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					                                                                           Chapter 1 and 2      1


Running head: CHAPTER 1, 2, 3




 Chapter 1, 2, 3, 4: Importance of the Problem, Research Question, Literature Review, Design,

                                     Plan of Evaluation

                                        Anita Swarup

                          University of the Sciences in Philadelphia
                                                                                  Chapter 1 and 2    2




Importance of the Problem

          The area of focus is Chronic Obstructive Pulmonary Disease otherwise known as

COPD. COPD is a lung disease in which the lungs are damaged, making it hard to breathe. In

COPD, the airways are partly obstructed. The airways and air sacs lose their shape and become

limp making it difficult to get air in and out ( Dressendorfer, Eves, Haykowsky, 2002). The

incidence of COPD is currently increasing in the U.S., with an estimated 16.5 million people

now suffering from shortness of breath and the immobilizing effects of this disease (Schoenstadt,

2006). Between 1979 and 1995, the number of individuals with COPD in the United States

increased relatively steadily from 7.5 million to 14.5 million persons (Schoenstadt, 2006). COPD

is the fourth leading cause of death in the United States for people ages 65 to 84, and it is the

fifth leading cause of death for people ages 45 to 64 and those age 85 and older (Schoenstadt,

2006). New government data based on a 1998 prevalence survey suggest that three million

Americans have been diagnosed with emphysema and nine million are diagnosed with chronic

bronchitis. COPD accounted for more than 112,000 deaths in 1998 (Rennard, 2000).

          Symptoms of COPD include cyanosis (poor oxygen supply), shortness of breath,

wheezing, hemoptysis (coughing up blood), weight loss, and lower extremity edema. These

symptoms prevent COPD patients from rigorous activities, and sometimes everyday activities

that require long periods of standing such as cooking, bathing, cleaning, and walking. Medical

treatment includes oxygen, anti-biotics, bronchodilators, and anti-inflammatory agents (

Dressendorfer, Eves, Haykowsky, 2002). OT Treatment includes breathing techniques, energy

conservation, and physical activity. It is believed that if they do not participate in physical

activity, then they will avoid shortness of breath, however physical activity will in turn improve
                                                                                Chapter 1 and 2    3


breathing ability in a patient. It takes a lot for persons with COPD to breathe properly, so

breathing techniques becomes a very important aspect of their life. If a person is not breathing

properly, then it makes them feel even more tired than they already are. Persons with COPD

require a good amount of energy throughout the day to control their shortness of breath, and

fatigue. Thus, energy conservation techniques are essential in preventing further complications

associated with fatigue, and shortness of breath.

       This proposal will have a beneficial impact on elderly COPD patients, because it will

identify whether exercise training or energy conservation techniques are more effective in

reducing the symptoms of COPD. The most important goals of OT are strictly linked with the

patient's autonomy, both to treat deficient activities and prevent any additional decline ( Bandura,

1997).Energy conservation techniques allow the resident to complete functional tasks efficiently

so they have more energy to participate in more meaningful activities (Schoenstadt, 2006). On

the other hand, physiological and psychological benefits have been reported in COPD patients

after participation in randomized controlled trials of prescribed exercise involving upper and

lower body aerobic and resistance training ( Dressendorfer, Eves, Haykowsky, 2002). The

comparison of both techniques is beneficial to practitioners, and elderly patients in deciding

which method is more suitable.



Research Question

Is exercise training more effective than energy conservation techniques (deep breathing, yoga,

pursed lip breathing) in reducing symptoms of COPD in the elderly?

Literature Review
                                                                                Chapter 1 and 2      4


         Elderly patients with COPD are often under treated (Medscape, 1999). Practitioners

may overlook the reversible component of COPD in the elderly, or characterize dyspnea to

excessive smoking or to atypical heart failure (Medscape, 1999). Similarly, until a few years ago,

patients older than 70 years had been excluded from some pulmonary rehabilitation studies

(Medscape, 1999). In fact, several factors do affect the ultimate success of rehabilitation in the

elderly, including the presence of other disabling diseases (eg, cancer or arthritis), long-term

medical therapy (for example, with oral steroids for COPD or other systemic diseases), level of

education, family support, and personal motivation (Medscape, 1999).

         Chronic Obstructive Pulmonary Disease (COPD) has become the fourth leading cause

of death in America (Schoenstadt, 2006). The role of OT is to maximize independence of the

person. COPD can have an intense impact on a person's ability to perform their activities of daily

living. As COPD progresses, the patient will have to expect and cope with difficulties on a daily

basis. Patients who are able to communicate and interact with others are most likely to adapt to

their changing circumstances (Schoenstadt, 2006). Many patients with COPD become unable to

communicate due to breathing problems such as shortness of breath. Currently there are many

treatment options available for COPD. Two essential components of an Occupational Therapy

treatment are breathing techniques/energy conservation, and exercise training. This proposes the

fact that whether exercise training is more effective than energy conservation techniques in

reducing symptoms of COPD in the elderly.



       A non-randomized parallel-group trial was performed in order to evaluate the

effectiveness of OT as an adjunctive measuring during pulmonary rehabilitation (PR) of

hospitalized COPD patients (Bellantone, Clini, Furino, Lorenzi, Lugli, Rizzardi, 2004).
                                                                                Chapter 1 and 2     5


Pulmonary Rehabilitation is a program of exercise classes that teaches you how to exercise and

do activities with less shortness of breath (Bellantone, Clini, Furino, Lorenzi, Lugli, Rizzardi,

2004). A clinical trial with parallel groups was started in severely disabled COPD patients. They

were assigned Occupational Therapy and Pulmonary Rehabilitation, or just Pulmonary

Rehabilitation. PR consisted of eighteen 3-hour daily sessions, while OT (domestic activities)

was added 3 times a week up to nine 1-hour sessions. Six-min walk with evaluation of dyspnea

and leg fatigue scores at end of effort, breathlessness sensation by means of the MRC scale as

well as the number of functions lost in the Basic Activity of Daily Living (BADL) (Bellantone,

Clini, Furino, Lorenzi, Lugli, Rizzardi, 2004). The major finding in this study is that only

patients of the Occupational Therapy & Pulmonary Rehabilitation showed significant

improvement during different BADL categories as opposed to the Pulmonary Rehabilitation

group which showed less improvement. At baseline, 17% of patients in the OT & PR group and

about 12% of patients in the PR group had lost 1 function according to BADL. After the

rehabilitation, there was a significantly higher percentage of patients with only 1 function lost in

the OT & PR but not in PR group, thus suggesting a positive effect due to OT intervention

(Bellantone, Clini, Furino, Lorenzi, Lugli, Rizzardi, 2004). This study shows that OT for basic

domestic activities during comprehensive pulmonary rehabilitation specifically improves the

outcome of severely disabled COPD inpatients.

       A randomized control study tested the effects of pranayama on COPD patients.

Pranayama are yogic breathing techniques (breathing techniques are a form of ECT) that

increase the capacity of lungs (Bihari, Katiyar, 2006). Forty eight patients (40 men and 8

women) with severe COPD were randomly divided (24 each) into two groups. Group 1 patients

were trained to do pranayama for 3 months for at least 30 minute duration. Both the groups were
                                                                                Chapter 1 and 2     6


allowed to continue with their usual physical activity and medications (Bihari, Katiyar, 2006).

The study demonstrated that in patients with significant COPD if specially trained for yogic

breathing called pranayama, show improvement of lung function parameters, improvement in the

exercise tolerance, symptoms score, their usual activity and reduction on the impact of disease on

their lives (Bihari, Katiyar, 2006).

       Another study investigated the impact of deep diaphragmatic breathing (DB) (which is a

type of energy conservation technique) on blood gases, breathing pattern, pulmonary mechanics

and dyspnea in severe hypercapnic chronic obstructive pulmonary disease (COPD) patients

recovering from an acute exacerbation (Ambrosino, Bianchi, Clini, Vitacca, 1998).Twenty five

patients were recruited during a period of 1 year from those admitted to our Intermediate

Intensive Care Unit, recovering from a recent episode of a noninfectious exacerbation of COPD

(Ambrosino, Bianchi, Clini, Vitacca, 1998). Transcutaneous partial pressure of carbon dioxide

(Ptc,CO2) and oxygen (Ptc,O2) and arterial oxygen saturation (Sa,O2), were continuously

monitored in 25 COPD patients with chronic hypercapnia, during natural breathing and DB

(Ambrosino, Bianchi, Clini, Vitacca, 1998). In eight of these patients, breathing pattern and

minute ventilation (V 'E) were also assessed by means of respiratory inductance

plethysmography (Ambrosino, Bianchi, Clini, Vitacca, 1998). In five tracheostomized patients,

breathing pattern and mechanics were assessed by means of a pneumotachograph/pressure

transducer connected to an oesophageal balloon (Ambrosino, Bianchi, Clini, Vitacca, 1998).

Subjective rating of dyspnoea was performed by means of a visual analogue scale (Ambrosino,

Bianchi, Clini, Vitacca, 1998). In comparison to natural breathing deep DB was associated with a

significant increase in Ptc,O2 and a significant decrease in Ptc,CO2, with a significant increase

in tidal volume and a significant reduction in respiratory rate resulting in increased V 'E
                                                                               Chapter 1 and 2    7


(Ambrosino, Bianchi, Clini, Vitacca, 1998). During DB, dyspnoea worsened significantly and

inspiratory muscle effort increased, as demonstrated by an increase in oesophageal pressure

swings, pressure-time product and work of breathing (Ambrosino, Bianchi, Clini, Vitacca,

1998).The study showed that in severe COPD patients deep diaphragmatic breathing is able to

improve blood gases and increase V 'E, whereas inspiratory muscle effort increases and dyspnea

worsens (Ambrosino, Bianchi, Clini, Vitacca, 1998).

       The purpose of a similar study conducted in 2005 was to examine the effect of volitional

pursed-lips breathing (PLB) on breathing pattern, respiratory mechanics, operational lung

volumes, and dyspnea in patients with COPD (Spahija, De Marchie, Grassino, 2005). Eight

patients (2 women and 6 men) with stable mild-to-severe COPD participated in the study, and

they were instructed on how to engage in the pursed lip breathing technique (Spahija, De

Marchie, Grassino, 2005). During the study the patients were seated on the bicycle ergometer,

while they breathed for 8 min using PLB and 8 min without using PLB (control breathing). This

was followed by 8-min periods of control breathing and PLB during constant-work-rate exercise.

The order of control breathing and PLB were changed among subjects, whereas exercise always

followed the resting condition. Subjects were allowed to rest for at least 10 to 15 min between the

two exercise runs (Spahija, De Marchie, Grassino, 2005). PLB promoted a slower and deeper

breathing pattern both at rest and during exercise. Overall, the study showed that volitionally

performed PLB by patients with COPD promoted a slower and deeper breathing pattern both at

rest and during exercise (Spahija, De Marchie, Grassino, 2005).

       In a previous study performed by B.R. Lindgren from the Division of Biostatistics School

of Public Health electronic spirometry units were used to monitor lung transplantation recipients

upon their return home. The data from 77 participants was used to come up with techniques to
                                                                               Chapter 1 and 2     8


confirm that the pulmonary function measurements, that forced vital capacity (FVC) and

expiratory volume in 1 s (FEV1), were reliable and valid (Lindgren, 2004). The standard

deviation was calculated for the best daily effort on repeated days of spirometry (Lindgren,

2004). The measure of day-to-day reliability was 0.20 for FVC and 0.15 for FEV1 (Lindgren,

2004). Validity was determined by examining the mean difference between the spirometry done

in the pulmonary function laboratory and the home monitoring results (Lindgren, 2004). The

clinic values were slightly higher, with an average difference of 0.15 for FVC and 0.12 for FEV1

(Lindgren, 2004).

       A study conducted by Universidade Federal de São Paulo in Brazil assessed the energy

spent by COPD patients using or not using energy conservation techniques (ECTs) during

activities of daily living (ADL) (Velloso, Jardim, 2006). Sixteen male COPD patients (62 years)

with moderate-to-very-severe COPD participated in the study (Velloso, Jardim, 2006). Dyspnea

was measured using the Borg scale, with the patient pointing to a scale indicating the degree of

dyspnea before and after performing each activity (Velloso, Jardim, 2006). Patients rested for 1

hour between the performance of the four exercises without using ECTs and the four exercises

using ECTs (Velloso, Jardim, 2006). Patients were required to perform ADL’s such as personal

hygiene activities, putting on/ taking off shoes, and storing food bags on high/low shelves with

ECT’s and without ECT’s (Velloso, Jardim, 2006). No significant difference in minute

ventilation using ECT-recommended postures was seen during the performance of personal

hygiene, putting shoes on and taking them off, and storing food bags on high shelves (Velloso,

Jardim, 2006). Activities related to personal hygiene presented a reduction of 13.7% in heart rate

when ECTs were used (Velloso, Jardim, 2006). When food bags were stored on high shelves,

there was a reduction of 5.1%, and when food bags were stored on low shelves, there was a
                                                                                   Chapter 1 and 2     9


reduction of 5.4% (Velloso, Jardim, 2006). There was a significant decrease in the dyspnea score

in all four activities performed with ECTs (Velloso, Jardim, 2006). Personal hygiene activities

presented a 1-point reduction in the Borg score. For putting shoes on and taking them off, the

reduction in Borg score was 0.6. For storing bags on high shelves, the reduction in Borg score

was 0.75. For placing bags on low shelves, the reduction in Borg score was 0.8 (Velloso, Jardim,

2006). Overall, the use of postures recommended by ECTs in patients with moderate-to-severe

COPD decreases dyspnea perception, as well as reduces heart rate (Velloso, Jardim, 2006).

        Spirometry will be used to measure the disability. It measures whether COPD is present,

and its severity. Therefore, the spirometry measurements have a high level of reliability and

validity and can be used for early detection of serious difficulties in COPD (Lindgren, 2004).

The spirometry classifies the severity of COPD as at risk (for developing COPD) when the

breathing test is normal. Mild signs that include a chronic cough and sputum production (Asthma

and COPD Center, 2007). Mild COPD when the breathing test shows mild airflow limitation.

Signs may include a chronic cough and sputum production. Moderate COPD when the breathing

test shows a deteriorating airflow limitation (Asthma and COPD Center, 2007). Usually the

signs have increased. Shortness of breath usually develops when working hard, walking fast, or

doing other brisk activities. At this stage, a person usually looks for medical attention (Asthma

and COPD Center, 2007). Severe COPD when the breathing test shows severe airflow

limitation. A person is short of breath after just a little activity, complications like respiratory

failure or signs of heart failure may develop (Asthma and COPD Center, 2007). At this stage, the

value of life is greatly weakened and the deteriorating symptoms can be life threatening (Asthma

and COPD Center, 2007). This is too much info for the methodology. Specify your measurement

tools and outline the plan. Will the severity of COPD be a selection criteria?
                                                                                 Chapter 1 and 2 10


       St George's Respiratory Questionnaire (SGRQ) is designed as a supervised self-

administered standardized questionnaire (Bihari, Katiyar, 2006). It is an instrument created to

determine the impact on overall health, daily life, and perceived well-being (Baveystock, Jones,

Littlejohns, Quirk, 2002). It was made for use by patients with fixed and reversible airway

obstruction (Baveystock, Jones, Littlejohns, Quirk, 2002). The patients complete the

questionnaire themselves under supervision of a paramedical staff (Bihari, Katiyar, 2006). Three

component scores are calculated for the SGRQ. Symptoms which focuses on the effect of

respiratory symptoms, their frequency and severity (Bihari, Katiyar, 2006).Activity which

focuses on activities that cause or are limited by breathlessness (Bihari, Katiyar, 2006). Impacts

which focuses on a range of aspects concerned with social functioning and psychological

disturbances resulting from airway disease (Bihari, Katiyar, 2006). The overall score sums up the

influence of the disease on the total health status within the last three months. Scores are

articulated as a percentage of total impairment where 100 represents worst possible health status

and '0' indicates best possible health status (Bihari, Katiyar, 2006). The reliability was

established in a previous Swedish study in which internal consistency reliability is satisfactory

Total test=0.91, Symptoms=0.81, Activity=0.88, Impacts=0.88 (Engström, Jones, Persson,

Sullivan, 1998). In general, answers to about three-fourth questions (37 of 50, 74.0%) correlated

significantly with their respective component scores, suggesting moderately high validity

(Engström, Jones, Persson, Sullivan, 1998).

       Exercise testing is mostly necessary to evaluate a persons’ exercise tolerance and to

expose any blood gas changes that cannot be seen from the baseline lung function tests.

Variables measured during testing should include workload, heart rate, electrocardiogram,

arterial oxygenation, and symptoms associated with the activity. The most successful assessment
                                                                                 Chapter 1 and 2 11


of exercise focuses on the type that will be done in training such as, treadmill testing for a

walking exercise training program or bicycle exercise. A previous study of exercise training done

in patients with COPD in an outpatient rehabilitation program showed a high test-retest

reliability of 0.3 to 0.8 m (Chan, Chan, Leung, Sykes, 2006). In this study a two-minute walk test

was done to asses the exercise capacity of COPD patients. The intraclass correlation coefficient

of the repeated 2MWTs was also high (R = 0.9994; p < 0.05) (Chan, Chan, Leung, Sykes, 2006).

Overall, the 2MWT was shown to be a reliable and valid test for the assessment of exercise

capacity and responsive following rehabilitation in patients with moderate-to-severe COPD

(Chan, Chan, Leung, Sykes, 2006).

       The Chronic Obstructive Pulmonary Disease Activity Rating Scale (CARS) is designed

to measure life-related activity, and was created to be used by people with chronic obstructive

pulmonary disease (Morimoto, Takai, Nakajima, Kagawa, 2002). The categories consist of self-

care, domestic, outdoor and social interaction Activities. The scaling is based on a 3-point scale

where 0 is dependant; 1 partially dependant; 2 completely dependent. The higher scores the less

impairment (Morimoto, Takai, Nakajima, Kagawa, 2002). Validity: The correlation between the

total score in the CARS and the PCS of the SF-12 was 0.58 (p<0.01). The correlation coefficient

between the CARS and pulmonary function tests was 0.47 for the FVC, 0.51 for the FEV1 and

0.39 for the %FEV1-predicted (p<0.01). The correlation between the breathlessness scores (per

Fletcher Hugh-Jones) and the CARS scores was -0.62 (P<0.01) (Morimoto, Takai, Nakajima,

Kagawa, 2002).

       The Baseline Dyspnea Index (BDI) a clinically derived index of the severity of patient

dyspnea based on functional impairment, magnitude of tasks that result in dyspnea, and the

degree of effort that produces dyspnea (Mahler, Weinberg, Wells, 1984). The BDI recognizes
                                                                                  Chapter 1 and 2 12


five grades for each of the following categories: functional impairment, magnitude of task, and

magnitude of effort (Mahler, Weinberg, Wells, 1984). The Baseline Dyspnea Index (BDI) looks

at the components of functional impairment, magnitude of effort and magnitude of task for

dyspnea evaluation (Mahler, Weinberg, Wells, 1984). A previous study performed at the

University of California administered by Eakin, Sassi-Dambron, Ries, and Kaplan compared a

various number of dypnea measures including the Baseline Dyspnea Index and the Transition

Dyspnea Index, UCSD Shortness of Breath Questionnaire (SOBQ), American Thoracic Society

Dyspnea Scale, Oxygen Cost Diagram, Visual Analog Scale, and Borg Scale. The evaluations

were reviewed for test-retest reliability internal consistency, interrater reliability, and construct

validity (Eakin, Kaplan, Ries, Sassi-Dambron, 1995). The results of the study implied that the

BDI demonstrated the highest levels of reliability and validity among the dyspnea measures

examined (Eakin, Kaplan, Ries, Sassi-Dambron, 1995).

         The study presented in this proposal focused on the effects of exercise training and

energy conservation techniques in patients with COPD, and is an expansion on prior research

done on this subject. This proposed study investigates the impact of exercise training, and energy

conservation techniques on elderly patients with COPD.

         It is hypothesized that persons with COPD who engage in exercise training, or energy

conservation techniques will lessen the amount of shortness of breath, wheezing, hemoptysis

(coughing up blood), and weight loss.

Chapter 3

Design

         This will be a randomized control study. Patients will be chosen at random using

computer generated randomization into two experimental groups: 24 patients will be trained to
                                                                                Chapter 1 and 2 13


participate in different forms of ECT’s 4 months for at least half an hour duration daily in along

with their usual physical activity and medications, 24 patients will participate in exercise

training, and 24 patients will be in a control group in which they will be allowed to continue with

their usual physical activity and medications for the same interval.

Subjects

       Inclusion Criteria: All patients > 40 years of age diagnosed with COPD, discharged from

an senior citizen rehab facility, and have been diagnosed COPD for at least one year ( post

exacerbation). Early and aggressive treatment of (COPD) exacerbations results in improved

recovery (Paggiaro, 2004). The people who meet the selection criteria will therefore be 2-3

weeks post discharge. Those who are admitted for other reasons besides COPD are also eligible,

and only patients with moderate to severe COPD will be included.

       Exclusion Criteria: Subjects have to be medically stable with no feverish or other severe

medical episodes which hinder their participation in exercise training and ECT’s. Also subjects

should have limited or no cognitive deficits, attentional deficits, any additional learning

disabilities, or known substance dependency. Individuals with psychiatric diagnoses that hinder

participation and concentration will also be excluded from the study.

Materials

       Spirometry will be used to measure the disability. It measures whether COPD is present,

and its severity. The Chronic Obstructive Pulmonary Disease Activity Rating Scale (CARS) is

designed to measure life-related activity, and was created to be used by people with chronic

obstructive pulmonary disease (Morimoto, Takai, Nakajima, Kagawa, 2002). St George's

Respiratory Questionnaire (SGRQ) is designed as a supervised self-administered standardized

questionnaire (Bihari, Katiyar, 2006). It is an instrument created to determine the impact on
                                                                                Chapter 1 and 2 14


overall health, daily life, and perceived well-being (Baveystock, Jones, Littlejohns, Quirk, 2002).

The Baseline Dyspnea Index (BDI) a clinically derived index of the severity of patient dyspnea

based on functional impairment, magnitude of tasks that result in dyspnea, and the degree of

effort that produces dyspnea (Mahler, Weinberg, Wells, 1984). Exercise testing is mostly

necessary to evaluate a persons’ exercise tolerance and to expose any blood gas changes that

cannot be seen from the baseline lung function tests. Each of these assessments will be utilized

during the study. The SGRQ and CARS will be used during the interview process, and after the

interventions. The spirometry, BDI, and exercise testing will be utilized during the interventions

to assess the impact of COPD.

Procedures

       Eligible individuals who are > 40 years of age diagnosed with COPD, discharged from an

senior citizen rehab facility, and have been diagnosed COPD for at least one year will be

enrolled in the study by the Research Coordinator. If the subjects give their permission to

participate, they will be randomly assigned to one of the three study groups. Subjects will be

assigned to and receive the interventions as they are recruited in the study. All groups will go

through a baseline interview prior to the intervention, which will be administered by professional

data collectors. This interview will include the Chronic Obstructive Pulmonary Disease Activity

Rating Scale (CARS), and St George's Respiratory Questionnaire (SGRQ). Also the subjects will

be tested before and after intervention using the spirometry to look at the severity of the disease.

Following the interviews the subjects will receive Occupational Therapy in which the focus will

be exercise training, and ECT’s (mainly breathing techniques).

       During randomization, chart review will be done to acquire the most up to date measures

of impairment for each subject. The Chart review will provide past medical history, information
                                                                                Chapter 1 and 2 15


on previous therapy sessions, cognitive status, physical status, sensory status, and motor status. It

will also reveal information on marital status, educational level, and employment status if any.

Occupational Therapists will make 16 visits to the subject’s homes for therapy sessions

       Subjects in the two experimental groups will be practicing ECT’s or exercise training.

The ECT’s will mainly be breathing techniques such as pursed lip breathing, and diaphragmatic

breathing. The exercise training will mainly be stretching, cardiovascular/ aerobic activity, and

strengthening. They will be participating in breathing or exercise techniques once a week during

each session for at least 30 minutes. The scheduled visits will occur once a week, if a subject is

unavailable due to illness or other reasons a visit can be made another day in that same week.

Through 16 visits the client and therapist should be able to establish a good client/ therapist

relationship. During the sessions the therapist will focus on breathing aspects of ECT’s or

exercise training. In the ECT group the therapist will teach the client proper breathing or exercise

techniques, and each week the client will practice these techniques for at least 30 minutes.

Gradually, the therapist will begin to incorporate activities in the home, and have the client apply

breathing techniques as needed during the activities. In exercise training group the therapist will

teach the client simple exercise training for COPD. Later the therapist will assess the amount of

exhaustion/ shortness of breath after exercise training. Together the therapist and client will

modify, or adapt to the environment when necessary during therapy sessions.

Visit 1  This visit will focus on building a relationship between the therapist, the client, and

caregiver. The therapist will assess the environment to evaluate adaptations made or if any are

needed. The client and therapist will talk about daily routines, roles and responsibilities in the

home. Lastly, the therapist and client will talk about what he/she has in mind to do with his/her

life and what goals he/she wants to set for future sessions. Before ending the session, the
                                                                                  Chapter 1 and 2 16


therapist will leave information on how they can be contacted and the time for the next visit will

be established.

Visit 2  Visit 2 will occur the week after visit one. The goals that were looked at in the first

visit 1 will be discussed to figure out if the client agrees. A plan to reach the goals will be set up.

Within the discussion of the goals, family involvement, interaction and role balance will be

addressed. Ultimately, the role of the caregiver in the intervention will also be discussed.

Visits 3- 15  During these sessions (every week), the interventions ( ECT’s = Breathing

techniques or exercise training) will assist and train the subject in participating in activities

which relate to goals set in the previous session. The breathing techniques will consist of pursed

lip breathing, deep breathing, and yoga. The exercise training will consist of ergometer, use of

light weights, walking, and standing activities such as meal preparation. The client will gradually

participate in these activities beginning with small light activities, and moving onto longer

activities. At the end of each session, the therapist and the client will go over progress and the

main goals will be addressed. The therapist will document any changes in strength, and

endurance. Performance evaluations will be completed during each visit and the therapist will

keep SOAP notes on each subject, as well as fill out a table of the progress. The documentation

will be made directly at the end of each visit regarding the therapist’s impressions concerning the

subject's progress or lack of progress and environmental barriers/ supports.

Visit 16  During the final visit, the therapist will conclude by going over the subject's

achievements. Focus will be on the subject's contributions toward achieving the goals,

overcoming environmental barriers, and talking about future goals and plans. Discussion will

concentrate on what was learned, and whether it was helpful and what the subject would change.

Finally, family or caregiver ideas will be discussed as well.
                                                                              Chapter 1 and 2 17


Visit Protocol

     Visits        ECT’s or Exercise Activity Type            Tolerance             Progress
                      Training
     Visit 1
     Visit 2
     Visit 3
     Visit 4
     Visit 5
     Visit 6
     Visit 7
     Visit 8
     Visit 9
    Visit 10
    Visit 11
    Visit 12
    Visit 13
    Visit 14
    Visit 15
    Visit 16



       The subjects in the control group will continue with their regular physical activity, and

medications with no therapeutic intervention. A therapist or nurse will go the subject’s homes

every week to monitor their status. Documentation of their status, and how they are feeling will

provide information on the effect of no therapy.

       The last portion of the study, one month after the study is over subjects in all groups will

receive a post-intervention interview offered at the subject's convenience in his or her home and

conducted by a data collector. The same set of measures as used in the beginning of the study
                                                                              Chapter 1 and 2 18


will be used again. During this process, the subject will again be tested using spirometry, and

also will go through the Chronic Obstructive Pulmonary Disease Activity Rating Scale (CARS),

and St George's Respiratory Questionnaire (SGRQ). The interviewer will also look at the amount

of social support the subject receives from family or friends. These data will give information on

the current services available to the groups, and will also give information that may impact the

outcome measures used in this study.

       Documentation of the therapy sessions will be done in SOAP note format. The SOAP

notes and subjects' confirmation of these notes will also be used to help determine the

effectiveness of the home-based intervention by providing information about the therapists' and

subjects' understanding of the intervention process.

Adequacy of Sample Size

Ethical Considerations

       All subjects will receive informed consent procedures.        After giving permission to

participate in the study subjects will get an identification number. The data will be recorded

under the ID number. A list of subjects’ names and ID numbers will be keep on a pass-word

protested spreadsheet on the researchers computer. All paper copies of data will be kept using

only the ID number. Information on individual subjects will be kept in a locked file cabinet in

the researcher’s office.

Chapter 4

Personnel

   1. Training and Experience of Principal Investigators and Key Personnel

   The proposed study will be applied and directed by established healthcare professionals in

the area of Occupational Therapy and Rehabilitation Medicine. The coordinator and investigators
                                                                                Chapter 1 and 2 19


will be apart of the staff of the senior citizen rehab facility. One Co- Principal Investigator will

be a certified Occupational Therapist who will have an adequate amount of experience in

geriatrics, and rehabilitation. Another Co- Principal investigator will be a healthcare professional

who is highly experienced in research, and who will also be an MD in Physical Medicine and

Rehabilitation.

   2. Allotment of Staff Time

   The Physical Medicine and Rehabilitation doctor will dedicate 20 % of his/her time to the

study. The Co –Principal investigator rehabilitation doctor will be managing the initiation of the

project, orderliness, financial aspects, and staff. The Co -Principal rehab doctor will supervise

the interventions, and organize them as well. The Co -Principal rehab doctor will also train other

OT’s who will be administering the interventions. The Co -Principal rehab doctor will also

assume the duty of assigning interventionists, and interviewers to the subjects take part in the

study. The Co -Principal OT will also be in charge of distributing the results of the study.

   The other Co – Principal investigator who is the OT will dedicate 25 % of his/her time to the

study. The OT will supervise the enrollment, randomization, assignment of subjects, and will

train the data collectors. The OT will assign subjects to groups, and facilitate data collection.

He/She will also direct data analyses, and help the rehab doctor with the distribution of findings.

       The research office is available to give management and support for the recruitment of

subjects, data collection, data storage, and analyses for all research studies associated with the

senior citizen rehab facility. The research office is also in charge of selecting those subjects who

meet the inclusion criteria for the study. The research office includes staff and technology

necessary to classify subjects who meet the criteria for the study. The computer database

contains the subjects name, address, phone number, social security number, medical record
                                                                               Chapter 1 and 2 20


number, past medical history, date of birth, diagnosis, date of admission, date of diagnosis, sex,

race, and current location. The research office makes sure that the data collected is reliable and

accurate. Whoever is involved in data collection undergoes training and reliability testing.

Overall, the research office is in charge of setting up subjects for research procedures involved in

the study making sure that the staff and subjects are aware of the date, time, and setting of the

scheduled procedures. To ensure precision during data collection each patient’s data will be

reviewed by an independent examiner who will evaluate all data for totality, and contradictory

information. Any mistakes will be adjusted by contacting the data collector or subject.

   3. Plan of Evaluation

       In an Occupational Therapy environment there are weekly evaluations, and meetings

   conducted to discuss patients, discharge, and other important factors. Basically, the

   investigators who are working on a study review the study weekly. During the administrative

   meeting the study will be audited to see what has been missed. Also the data will be reviewed

   for reliability, and plans for data analyses will be talked about.

       There will be an evaluation team that the investigators will meet with regularly. The team

   will include staff from the OT department, and the Physical Medicine and Rehabilitation

   department. The team will review the study for scientific merit and make sure that the

   purpose is being met, and will recommend changes needed to meet the objectives. The team

   will also review subject agreement, and adequacy of sample size and methodology to assure

   that there is development. An advisory board has also been made to supervise the study. This

   board will offer guidance from numerous members of the physical medicine and

   rehabilitation department.

   4. Plan of Operation
                                                                       Chapter 1 and 2 21


The first four months of the study will be devoted to coming up with the subject pool. The

Principal investigators will train the interventionists and interviewers to phone numerous

subjects.




                                     Time Line Year 1
                                        MONTHS
                    1      2     3      4     5      6     7     8      9     10    11       12
Activities

  Recruit and
 enroll subjects
     Train
interventionists/
 data collectors

Pretest Subjects



    CONDUCT
    PROGRAM




Posttest Subjects



  Analyze Data

 Write Reports



                                       Time Line Year 2
                                                             Chapter 1 and 2 22


                                  MONTHS
                13   14   15   16  17    18   19   20   21    22    23    24
  Activities


  Analyze
questionnaire
    Data




  Recruit
Interviewers




   Train
Interviewers


   Recruit
  Interview

 Participants
    Team

  Meeting

   Develop
  interview
  questions


  Conduct
 Interviews




  Meet with
TeamMembers
                                                           Chapter 1 and 2 23




   Year End
    Report




                             Time Line Year 3

                                 MONTHS
                  25   26   27   28  29     30   31   32    33    34     35     36
Activities

   Continue to
    Conduct
   Interviews


    Thematic
   Analysis of
 Interview Data


  SYNTHESIZE
  QUALITATIVE
       AND
 QUANTITATIVE
     DATA
  INTOTHEMES

     Team
    meeting
  Review Data
  Synthesis and
    Themes

   Meet with
 TeamMembers
                                                                                  Chapter 1 and 2 24



  Final Report

       meetings


       One of the Co- Principal Investigators will be in charge of identifying the patients who

were chosen through the inclusion criteria. Once the patients are recruited a Co- Principal

investigator will be in charge of tracking the subject. Patients will be identified as potential

subjects while they are in the senior citizen rehab facility. After discharge from Rehab subjects

will be asked to participate in the study.

   5. Collaborations

   This study is a collaboration of the department of Occupational Therapy, the department of

Physical Medicine and Rehabilitation, and the senior citizen rehabilitation facility.
                                                                              Chapter 1 and 2 25


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Chapter 1 and 2 27
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