Final Progress Report for Research Projects Funded by
Health Research Grants
Instructions: Please complete all of the items as instructed. Do not delete instructions. There is
no limit to the length of your responses to any question. Responses should be single-spaced, no
smaller than 12-point type. Questions? Contact Health Research Program staff at 717-783-
1. Grantee Institution: Arcadia University
2. Reporting Period (start and end date of grant award period): January 1, 2007-May 31,
3. Grant Contact Person (First Name, M.I., Last Name, Degree(s):
Barbara A Sheehan, M.Ed.
4. Grant Contact Person’s Telephone Number: 215-572-2887
5. Grant ME Number or SAP Number: 4100037704
5. Project Number and Title of Research Project: Project #1 - Multimodal Exercise Training
for Older Adults After Hip Fracture
6. Start and End Date of Research Project: January 1, 2007-May 31, 2008
7. Name of Principal Investigator for the Research Project:
Kathleen Kline Mangione, P.T., Ph.D.
8. Research Project Expenses.
9(A) Please provide the amount of health research grant funds spent on this project for the
entire duration of the grant: $15,155
9(B) Provide the names of all persons who worked on this research project and were
supported with health research funds. Include position titles (Principal Investigator,
Graduate Assistant, Post-doctoral Fellow, etc.), percent of effort on project and total health
research funds expended for the position.
Last Name Position Title % of Expenses
Mangione PI 20% 0
Eastlack Investigator 5% 0
Konersman Research assistant - trainer 50% $8424
Muth Research assistant - trainer 20% $2950
Palombaro Research assistant - examiner 5% $976
Roberto Recruitment honorarium na $200
9(C) Provide the names of all persons who worked on this research project, but who were not
supported with health research funds. Include position titles (Research Assistant,
Administrative Assistant, etc.) and percent of effort on project.
Last Name Position Title % of Effort
McCloy Research assistant - trainer 20%
9(D) Provide a list of all scientific equipment purchased as part of this research grant and the
value derived by the institution from this equipment.
Type of Scientific Equipment Value Derived Expenses
10. Co-funding of Research Project during Health Research Grant Award Period. Did this
research project receive funding from any other source during the project period when it was
supported by the health research grant?
If yes, please indicate the source and amount of other funds:
11. Leveraging of Additional Funds
11(A) As a result of the health research funds provided for this research project, were you
able to apply for and/or obtain funding from other sources to continue or expand the
If yes, please list the applications submitted (column A), the funding agency (National
Institutes of Health—NIH, or other source in column B), the date the application was
submitted (column C), and the amount of funds requested (column D). If you have received
a notice that the grant will be funded, please indicate the amount of funds to be awarded
(column E). If the grant was not funded, insert “not funded” in column E.
A. Title of research project B. Funding C. Date D. Amount E. Amount
on grant application agency (check Submitted of funds of funds to
those that apply) requested: be awarded:
Separating the cream- a NIH March 31, $1,500,000 $under
clinical tool for hip fracture Other source- 2008 review
NIH $ $
NIH $ $
11(B) Are you planning to apply for additional funding in the future to continue or expand
If yes, please describe your plans: These data are going to be combined with data collected at
two other research institutions. We are planning to use this data as pilot information for an
R01 examining the effectiveness of this early aggressive exercise program for recovery after
12. Future of Research Project. What are the future plans for this research project? There are
no future plans of this specific project. This project allowed me to determine that patients can
successfully perform high intensity strength and aerobic training early in the recovery period.
This feasibility stage was necessary before we could apply for federal funding to suggest
such an intensive program.
13. New Investigators. Were funds used to pay for research performed by pre- or post-doctoral
students as part of this project?
Yes_____ ____ No____X______
If yes, how many pre- and post-doctoral students received support?
14. Recruitment of Out-of–State Researchers. Did you bring researchers into Pennsylvania to
carry out this research project?
If yes, please list the name and degree of each researcher and his/her previous affiliation:
15. Impact on Research Capacity and Quality. Did the health research project enhance the
quality and/or capacity of research at your institution?
Yes____ _____ No_____ X_____
If yes, describe how improvements in infrastructure, the addition of new investigators, and
other resources have led to more and better research.
16. Collaboration, business and community involvement.
16(A) Did the health research funds lead to collaboration with research partners outside of
your institution (e.g., entire university, entire hospital system)?
Yes____X_____ No_____ _____
If yes, please describe the collaborations: I have trained research assistants at the University
of Maryland and the University of Connecticut for the methods used. We will use the pooled
data as pilot data for an R01 project this fall.
16(B) Did the research project result in commercial development of any research products?
If yes, please describe commercial development activities that resulted from the research
16(C) Did the research lead to new involvement with the community?
If yes, please describe involvement with community groups that resulted from the research
17. Progress in Achieving Research Goals, Objectives and Aims.
List the project goals, objectives and specific aims (as contained in the grant application’s
strategic plan). Summarize the progress made in achieving these goals, objectives and aims
for the entire grant award period. Indicate whether or not each goal/objective/aim was
achieved; if something was not achieved, note the reasons why. Describe the methods used.
If changes were made to the research goals/objectives/aims, methods, design or timeline
since the original grant application was submitted, please describe the changes. Provide
detailed results of the project. Include evidence of the data that was generated and analyzed,
and provide tables, graphs, and figures of the data.
Note: This response should be a DETAILED report of the methods and findings. It is not
sufficient to state that the work was completed. Insufficient information may result in an
unfavorable performance review, which may jeopardize future funding. There is no limit to
the length of your response. Responses must be single-spaced below, no smaller than 12-
point type. DO NOT DELETE THESE INSTRUCTIONS.
Purpose: To determine if a 16-week, multi-component intervention, initiated 2-3 months
post-fracture, leads to greater improvements in the ability to walk a distance indicative of the
ability to ambulate in the community as compared to a randomly selected control group. We
will also examine the effects of exercise on leg strength, walking speed, balance and
Primary Aim: To determine if a 16-week, multi-component intervention initiated 2-3 months
post-fracture, leads to greater improvements in the ability to walk a distance indicative of the
ability to ambulate in the community at 4 months after study entry than a no-treatment
control. Secondary Aim: To compare exercise and control groups on measures of lower
extremity function, lower extremity muscle performance, and endurance.
Subject recruitment and selection: Subjects were recruited from the local community. The
director of rehabilitation services from a local home health care agency sent letters to all
patients 65 years of age or older who sustained a hip fracture. The letter described the study
and asked the patient to contact the PI if they were interested in learning more about the
study. If the patient call the PI, the PI screened the patient for the following conditions: 1)
diagnosis of hip fracture (ICD-9 codes 820.0 to 820.9); 2) age 65 or older; 3) living in the
community at time of fracture; 4) hospitalization within 4 days of the fracture; 5) successful
fixation (partial or total hip replacement or open reduction internal fixation) of a hip fracture;
6) non-pathologic fracture; 7) minimal trauma fracture; and 8) ambulating without human
assistance pre-fracture. Potential participants were excluded if they had medical conditions
including recent history of unstable angina or congestive heart failure (3 months); were
undergoing chemotherapy for cancer; were receiving renal dialysis; had history of stroke
with residual hemiplegia; had Parkinson’s disease, diagnosis of schizophrenia or other
psychosis; had an exercise-exacerbated neuromuscular disorder; had hepatitis, HIV, or
endocarditis. These criteria were assessed via phone interview. Additional exclusions
included resting systolic BP >180 mm Hg or resting diastolic BP > 90 mm Hg; inability to
walk 10 ft without human assistance (by observation); irreducible leg-hip contractures (hip
flexion >40 degrees and/or knee flexion >20 degrees) (measured with a goniometer);
severely diminished lower extremity sensation; and a Mini-Mental State Examination score
<20. These criteria were assessed during a visit to the person’s home.
All outcome measures were obtained at the Health Science Center labs of Arcadia
University. The primary study outcome was a measure of the minimum distance a person
needs to be able to walk to carry out usual activities in the community. This was defined as
achieving the threshold value of 300 meters or more on the Six Minute Walk Test (SMWT),
a measure of the maximal distance a person can walk in 6 minutes on a standard walking
course. The SMWT was used as the measure of endurance. Heart rate, blood pressure, and
dyspnea (3) were recorded before and immediately after the walk. Distance was measured in
feet and converted to the nearest meter. Muscle performance characteristics of maximal
isometric force were obtained for bilateral knee extensors. Isometric force was measured
with a portable, hand-held dynamometer (Chatillon Digital Force Gauge 500). The subject
was seated on a chair, with the hip and knee flexed to 90°. The trunk and thigh were
stabilized with straps and resistance was applied just proximal to the ankle on the anterior
surface of the leg. The participant was asked to push as hard and as fast as possible for five
seconds. Two maximal effort trials, with a minute rest between trials were collected. The
Physical Performance Test is a 9 item performance-based measure where each item is scored
from 0 (unable to do the task) to 4 (able to do task quickly) for a total possible score of 36.
Falls and hospital rates will be queried by phone every month for subjects in the both groups.
Multi-Component Training Intervention: Training was provided 3x/week for the first 8
weeks, and then 2x/wk for the remaining 8 weeks. All training was provided by a licensed
physical therapist. Endurance training was used to start all sessions to ensure adequate warm
up for muscles. Blood pressure and resting heart rate (HR) were measured at the beginning of
each session. The HR training zone was calculated by the heart rate reserve (HRR) method
(HRmax-HR rest)multiplied by 50% and then added to HR rest. HR max was calculated as
220 minus the patient’s age. For persons taking medication that controls heart rate (e.g. ß-
blockers), Borg’s Rate of Perceived Exertion (PE) scale was used. The training intensity
using the PE scale was “moderate” work as consistent with a #3- #4 on the 0 to 10 scale.
The endurance intervention began initially with two to three minutes of continuous upper and
lower extremity active range of motion with the participant sitting. The participant was then
asked to walk on level surfaces and up and down a single or multiple steps, if able and
available, to keep the HR within the training zone for 20 minutes. The guidelines were that
the intensity of the training be + 5 beats of the prescribed HR, the duration be 20 continuous
minutes, and the program include as much upright standing and walking as possible.
The strength components of the muscle performance intervention were performed using a
portable progressive resistive exercise (PRE) machine.(Shuttle® MiniClinic, Contemporary
Design Company, P.O. Box 5089, Glacier, WA 98244) The machine has six latex bands each
with a starting load equal to approximately 6 pounds. At full excursion one band can provide
approximately 20 pounds of force. These latex bands provide the resistance and are attached
to the machine by a slotted bar on the frame. Inserting more bands into the slotted bar
increases the resistive load for the participant. When more than one band is used, the values
Muscle performance was focused on bilateral hip extensors, hip abductors, knee extensors,
and plantar flexors. These muscles were chosen because of their role in function, specifically
gait and transfer activities. The intensity of the strength training was determined during the
first day of intervention at the person’s place of residence. The PT determined the amount of
resistance the person can push against so that the participant completed a maximum of 8
repetitions (8-RM). The participant performed 3 sets of 8 repetitions at the 8-RM intensity.
The PT provided strong verbal encouragement during each repetition for the participant to
move as “fast and as hard as possible” during the concentric phase and to move slowly and
controlled in the eccentric phase. Intensity was adjusted every two weeks.
The participants were supine for 2 exercises: the combination of hip and knee extension
exercise (leg press) as well as for hip abduction exercise. Balance and strength were
addressed with two additional exercises performed in standing. Balance was addressed as the
patient performed one-legged activities (standing hip extension) or standing upright with a
decreased base of support (standing plantar flexion). Initially, patients were asked to decrease
their standing base of support by rising onto the balls of feet. This exercise also strengthened
the plantar flexors. Balance and strength were progressively challenged by advancing the
activity to unilateral heel raises. The person held lightly onto an assistive device for balance
Results: Seventy letters were sent to prospective patients, age 65 and older who were
receiving home care physical therapy with a primary diagnosis of hip fracture. From these
letters, 14 people contacted us and 10 were eventually randomized. The four who were
contacted but not recruited were not eligible due to Parkinson’s disease (n=1), too long a time
between fracture and surgery (n=1), fractured mid femur not hip (n=1), and too long post
fracture (n=1). Of the 10 patients recruited, nine completed the protocol. The patient who did
not complete the protocol sustained multiple falls during the first few weeks of the
intervention and declined further participation. There were five subjects who completed the
control group and four who completed the exercise group.
The demographics characteristics of the full sample are as follows. There were four men and
six women with a mean age of 79.4 years (range 70-88 yrs). Three of the fractures were
extra-capsular (inter-trochanteric) and were fixated with plates and screws while the
remaining seven were intra-capsular fractures fixated with hemiarthroplasties. The patients
were taking 10 medications, on average, for nine co-morbid conditions listed in the past
medical history of the medical record. On average, baseline assessments were conducted
10.8 weeks post fracture.
The outcomes suggest that the exercise group improved in several important areas related to
function. The goal of achieving 300 meters during the six-minute-walk test was not achieved
by either group, but the improvement in distance was greater for the exercise group as
compared to the control group. The modified physical performance test scores also suggested
that the exercise group performed better than the control group. An increase in 5 points is a
meaningful improvement. The exercise group also showed large improvements in the self-
reported physical function and vitality as measured by the SF-36. The surprising findings
were the lack of change in the strength measure and the increase speed of walking for the
control group during the 50 ft walk test. The lack of strength gains could be due to several
factors. First, it is possible that the exercise group did not get stronger. This view is not
consistent with the training data which show increases in the bimonthly training logs. The
testing protocol consisted of isometric testing of the quadriceps at 90 degrees of knee flexion.
There were no isometric exercises performed and testing at 90 degrees can be painful for
persons with osteoarthritis of the knees. Several of our subjects had osteoarthritis and it is
possible that local joint pain inhibited muscle performance during the test. The third potential
source of error could have been our examiner. The participants produced relatively similar
amounts of force even though their heights and weights were not similar. It is possible that
the examiner provided a consistent amount of resistance for each participant rather than
individually tailoring the resistance to meet the maximal capacity of the participant. The
change in 50 foot walk speed was driven by one subject who improved almost 40 seconds
whereas the other subjects improved by 5.5 seconds, on average. If this one control
participant was excluded from the analysis, the group difference would have been 5.2
seconds faster for the control group versus 8.1 seconds faster for the experimental group.
This analysis is more consistent with the other results from the study. The detailed results
appear below in table one.
Table 1: Outcomes
Control Group Exercise Group
Mean SD Mean SD
Physical function -baseline 46.00 24.083 33.75 20.565
Outcome 45.00 31.623 52.50 23.979
Role Physical-baseline 35.00 48.734 31.25 31.458
Outcome 35.00 28.504 31.25 31.458
Bodily Pain-baseline 72.00 18.547 59.50 13.204
Outcome 73.40 17.430 59.25 19.414
General Health- baseline 61.60 23.522 64.75 15.945
Outcome 68.00 20.433 61.50 27.767
Vitality-baseline 56.00 28.810 36.25 9.465
Outcome 44.00 27.477 46.25 17.970
Social Function-baseline 70.000 16.7705 62.500 32.2749
Outcome 85.00 20.540 84.38 15.729
Role Emotional- baseline 93.32 14.937 100.00 0.000
Outcome 86.66 29.829 100.00 0.000
Mental Health-baseline 80.00 16.248 74.00 8.327
Outcome 79.20 16.100 79.00 15.449
6-minute-walk distance-baseline 193.20 95.062 170.00 28.740
Outcome 202.50 117.555 217.25 71.056
50 ft walk time-baseline 33.40 15.567 34.93 10.049
Outcome 19.2000 1.86928 26.8125 13.80128
Modified Physical Performance
Test- baseline 15.80 5.215 15.50 3.000
Outcome 18.00 9.566 21.00 8.287
Isometric Force of Quadriceps-
unfractured leg(lbs) 21.166 5.5183 24.150 2.5321
Outcome 22.5900 7.04613 23.2625 4.46680
Isometric Force of Quadriceps-
fractured leg(lbs) 20.266 5.4346 18.300 6.2179
Outcome 21.680 6.2757 21.950 8.9830
highlighted areas show clinically relevant changes
18. Extent of Clinical Activities Initiated and Completed. Items 18(A) and 18(B) should be
completed for all research projects. If the research project involved clinical research (the
testing of treatment, prevention or diagnostic procedures on human subjects), items 18(C) –
(F) must also be completed.
18(A) Did you initiate a study that involved the testing of treatment, prevention or
diagnostic procedures on human subjects?
18(B) Did you complete a study that involved the testing of treatment, prevention or
diagnostic procedures on human subjects?
18(C) How many hospital and health care professionals were involved in the research
__7____Number of hospital and health care professionals involved in the research
18(D) How many subjects were included in the study compared to targeted goals?
___8___Number of subjects originally targeted to be included in the study
___10___Number of subjects enrolled in the study
18(E) How many subjects were enrolled in the study by gender, ethnicity and race?
______Latinos or Hispanics
__10____Not Latinos or Hispanics
______American Indian or Alaska Native
______Blacks or African American
______Native Hawaiian or Other Pacific Islander
18(F) Where was the research study conducted? (List the county where the research
study was conducted. If the treatment, prevention and diagnostic tests were offered in
more than one county, list all of the counties where the research study was
Montgomery County, PA
19. Human Embryonic Stem Cell Research. Item 19(A) should be completed for all research
projects. If the research project involved human embryonic stem cells, items 19(B) and
19(C) must also be completed.
19(A) Did this project involve, in any capacity, human embryonic stem cells?
19(B) Were these stem cell lines NIH-approved lines that were derived outside of
19(C) Please describe how this project involved human embryonic stem cells:
20. Articles Submitted to Peer-Reviewed Publications.
20(A) Identify all publications that resulted from the research project and that have been
submitted to peer-reviewed publications. Include only those publications that acknowledge
the Pennsylvania Department of Health as the funding source (as required in the grant
agreement). List the title of the journal article, the authors, the name of the peer-reviewed
publication, the date it was submitted, and the status of publication (submitted for
publication, accepted for publication or published.). Submit an electronic copy of each
publication in a PDF version 5.0.5 format, 1,200 dpi. Filenames for each publication should
include the number of the research project, the last name of the PI, the number of the
publication and an abbreviated research project title. For example, if you submit two
publications for PI Smith for the “Cognition and MRI in Older Adults” research project
(Project 1), and two publications for PI Zhang for the “Lung Cancer” research project
(Project 3), the filenames should be:
Project 1 – Smith – Publication 1 – Cognition and MRI
Project 1 – Smith – Publication 2 – Cognition and MRI
Project 3 – Zhang – Publication 1 – Lung Cancer
Project 3 – Zhang – Publication 2 – Lung Cancer
If the publication is not available electronically, provide 5 paper copies of the publication.
Note: The grant agreement requires that recipients acknowledge the Pennsylvania
Department of Health funding in all publications. Please ensure that all publications listed
acknowledge the Department of Health funding. If a publication does not acknowledge the
funding from the Commonwealth, do not list the publication.
Title of Journal Authors: Name of Peer- Date Publication
Article: reviewed Submitted: Status (check
Publication: appropriate box
20(B) Based on this project, are you planning to submit articles to peer-reviewed publications
in the future?
Yes_________ No__X___- this was pilot work
If yes, please describe your plans:
21. Changes in Outcome, Impact and Effectiveness Attributable to the Research Project.
Describe the outcome, impact, and effectiveness of the research project by summarizing its
impact on the incidence of disease, death from disease, stage of disease at time of diagnosis,
or other relevant measures of outcome, impact or effectiveness of the research project.
Responses must be single-spaced below, and no smaller than 12-point type. DO NOT
DELETE THESE INSTRUCTIONS. There is no limit to the length of your response.
The outcome of this pilot study showed that patients in the acute phase of recovery from hip
fracture (less than 3 months post fracture) are able to perform both aggressive strength
training and aerobic training without detrimental effects. From this small, heterogeneous
sample it is impossible to tell if the intervention was effective on the group level, but the
trends from the group suggest that the changes were occurring in the expected direction. The
outcomes also showed me that our original goal of achieving 300 meters in the six-minute-
walk test were too optimistic for this sample. On average, the group only walked 200 meters
at the end of the trial (6-7 months post fracture). Whether patients could meet the higher
threshold at one year post fracture is not known. Other data we have suggests that the
exercise program may have a latent effect such that larger gains are noted between groups
several months after the study. We did not include measures at one year post fracture, so the
long-term outcomes remain elusive with this intervention. We believe this data (combined
with the data at the other clinical sites) is sufficient to show the safety of the intervention and
the ability of multiple sites to carry out the same intervention.
22. Major Discoveries, New Drugs, and New Approaches for Prevention Diagnosis and
Treatment. Describe major discoveries, new drugs, and new approaches for prevention,
diagnosis and treatment that are attributable to the completed research project. Responses
must be single-spaced below, and no smaller than 12-point type. DO NOT DELETE THESE
INSTRUCTIONS. There is no limit to the length of your response,
No new drugs or discoveries were made with this study.
23. Inventions, Patents and Commercial Development Opportunities.
23(A) Were any inventions, which may be patentable or otherwise protectable under Title 35
of the United States Code, conceived or first actually reduced to practice in the performance
of work under this health research grant? Yes No X
If yes, complete items a – g below for each invention.
a. Title of Invention:
b. Name of Inventor(s):
c. Technical Description of Invention (describe nature, purpose, operation and physical,
chemical, biological or electrical characteristics of the invention):
d. Was a patent filed for the invention conceived or first actually reduced to practice in
the performance of work under this health research grant?
If yes, indicate date patent was filed:
e. Was a patent issued for the invention conceived or first actually reduced to practice in
the performance of work under this health research grant?
If yes, indicate number of patent, title and date issued:
Title of patent:
f. Were any licenses granted for the patent obtained as a result of work performed under
this health research grant? Yes No
If yes, how many licenses were granted?
g. Were any commercial development activities taken to develop the invention into a
commercial product or service for manufacture or sale? Yes No
If yes, describe the commercial development activities:
23(B) Based on the results of this project, are you planning to file for any licenses or patents,
or undertake any commercial development opportunities in the future?
If yes, please describe your plans: