Hip FractureNCT00592813
Efficacy of a Post-Rehabilitation Exercise Intervention
A study testing Enhanced Strong for Life and cardiovascular nutrition education in people with Hip Fracture and Disability, run by Boston University at 1 site in United States.
Trial summary
Background: Many people who have suffered a hip fracture are discharged from rehabilitation services with significant residual functional limitations and disability. We believe that a home-based exercise program that incorporates cognitive-behavioral techniques to increase exercise adherence and promote the return to… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Hip Fracture, Disability
- What is being tested?
- Enhanced Strong for Life and cardiovascular nutrition education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 232 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Nov 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a primary diagnosis of hip fracture;
- Aged 60 years and above;
- Have functional limitation (i.e., as determined by limitation in at least one of 9 functional tasks listed in the SF-36 physical function scale, excluding vigorous activities);
- Have recently been discharged from rehabilitation services;
- Be able to understand and communicate in English;
- Be able to safely and independently stand with or without the aid of a mobility device, without needing any assistance or supervision from another person;
- Have received written clearance from their primary care physician documenting no contra-indications for participating in the study;
- Be able to provide written informed consent.
Who cannot join
- Have serious cognitive deficits (i.e., a Mini-Mental State Examination score of less than 20)85;
- Have severe depression (i.e., a score of 20 or greater on the Geriatric Depression Scale)86;
- Have a terminal illness with survival expected to be less than 1 year;
- Have significant pulmonary or cardiovascular contraindications or pre-existing conditions that preclude participating in an exercise program;
- Legally blind;
- Currently receiving rehabilitation therapy;
- Live outside of the study's catchment area in the Boston metropolitan area and eastern Massachusetts.
Trial locations and contacts
1 site in 1 country.
United States1 site
Spaulding Rehabilitation Hospital
Cambridge, Massachusetts, 02138
About this study
Background:
Many people who have suffered a hip fracture are discharged from rehabilitation services with significant residual functional limitations and disability. We believe that a home-based exercise program that incorporates cognitive-behavioral techniques to increase exercise adherence and promote the return to daily activities could extend the benefits of formal rehabilitation for patients who have suffered a hip fracture.
Read more
Specific Aims:
We will conduct a 5-year multi-site randomized controlled trial in patients who have suffered a recent hip fracture and have completed all rehabilitation services. The specific aim that this project will address is whether:
Participation in the Strong for Life (SFL) program will improve function and disability outcomes in participants 6-months after they are discharged from rehabilitation services.
This study will also investigate the following secondary hypotheses:
- Changes in function and disability at 6-month follow-up will be correlated with changes in all three proposed intermediary variables: muscle strength, balance, and self-efficacy.
- The SFL program will significantly improve health-related quality of life among participants at 6-month follow-up.
- At 9-month follow-up the SFL program will continue to have a significant impact on participants' function and disability compared to the control group.
Target population:
The target population will be people aged 60 years or more who have suffered a recent traumatic hip fracture, have one or more residual functional limitations and have completed all inpatient, outpatient or homecare rehabilitation services.
Intervention:
We will use an enhanced version of the Strong for Life program. This home-based exercise program will include both resistance exercises using Thera-bands that will be shown on a video/DVD and weight-bearing exercises that are progressed using a step and/or a weighted vest. A cognitive-behavioral program that is customized for people recovering from hip fracture is being developed that will focus on promoting exercise adherence, decreasing fear of falling and increasing the return to daily activities in the patient's home and community.
Design:
A randomized controlled clinical trial will be implemented to measure the efficacy of the Strong for Life program. An attention-control intervention will be provided to all participants assigned to the control group. The outcome evaluation points are:
- T0: baseline, at the point of discharge from formal rehabilitation;
- T2: 6-month outcome assessment
- T3: 9-month follow-up
Outcomes:
The primary outcomes will be function measured by both self-report (AM PAC) and physical performance measures (SPPB). Secondary outcomes include disability, self-efficacy, balance, strength, cognition, and reaction time. Adherence to the exercise program and adverse events will also be monitored.
- Conditions
- Hip Fracture, Disability
- Being tested
- Enhanced Strong for Life, cardiovascular nutrition education
- Keywords
- rehabilitation, function
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Strong for LifeBehavioural
The program contains 5 minutes of warm-up, 25 minutes of strengthening, and 5 minutes of cool-down exercises. The SFL program is contained on a 35 minute videotape. Subjects are instructed to increase resistance when they can perform 10 repetitions of a movement pattern without significant fatigue or loss of proper execution. Subjects are instructed to move within a comfortable range of motion.
Participants will be taught the SFL program during two home visits conducted by a physical therapist. On the first visit, the exercise techniques will be taught, modified as needed based on individual needs and practiced as necessary until proper technique is attained. Each participant will be given written guidelines for how to progress resistance of the program, how to modify the exercises and how to complete bimonthly exercise calendars.
cardiovascular nutrition educationBehavioural
administered as an attention control intervention using home visits, phone calls and mail-outs of information
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Behavioral: Enhanced Strong for Life |
| cardiovascular education (attention control) | Placebo comparator | Not described Receives: Behavioral: cardiovascular nutrition education |
What is being measured
The primary outcome is the main question the study is designed to answer.
The specific aim that this project will address is whether: Participation in the SFL program will improve function and disability outcomes in participants 6-months after they are discharged from rehabilitation services.
performance based function is assessed using the Short Physical Performance Battery (SPPB) and self-reported function is assessed using the AM-PAC
Measured: baseline, 6-month and 9-month follow up
Secondary outcomes (2)
Changes in function and disability at 6-month follow-up will be correlated with changes in all three proposed intermediary variables: muscle strength, balance, and self-efficacy.
Measured: baseline, 6-month and 9-month follow up
At 9-month follow-up the SFL program will continue to have a significant impact on participants' function and disability compared to the control group.
Measured: baseline, 6-month and 9-month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2008 (estimated)
- Study startApr 2008
- Primary completionSep 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hip FractureStudies of the same condition, open and under way.
- More trials run by Boston UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 232 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR), Spaulding Rehabilitation Hospital
- Responsible party
- Principal investigator, Alan Jette, Boston University
- Investigators
- Alan M Jette, PhD, Principal investigator, Health & Disability Research InstituteNancy Latham, PhD, Principal investigator, Health & Disability Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00592813
- Sponsor's protocol ID
- NINR 1R01NR010815-01A2
- Other IDs
- 1R01NR010815-01A2
- Status last verified
- Apr 2013
- First submitted
- 2 Jan 2008
- Last updated
- 23 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Latham NK, Harris BA, Bean JF, Heeren T, Goodyear C, Zawacki S, Heislein DM, Mustafa J, Pardasaney P, Giorgetti M, Holt N, Goehring L, Jette AM. Effect of a home-based exercise program on functional recovery following rehabilitation after hip fracture: a randomized clinical trial. JAMA. 2014 Feb 19;311(7):700-8. doi: 10.1001/jama.2014.469.
PubMed 24549550
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Post-Rehabilitation Exercise Intervention
- ClinicalTrials.gov ID
- NCT00592813
- Acronym / sponsor ID
- NINR 1R01NR010815-01A2
- Conditions
- Hip Fracture, Disability
- Keywords
- rehabilitation, function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 232 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR), Spaulding Rehabilitation Hospital
- Study start
- Apr 2008
- Primary completion
- Sep 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 14 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
Many people who have suffered a hip fracture are discharged from rehabilitation services with significant residual functional limitations and disability. We believe that a home-based exercise program that incorporates cognitive-behavioral techniques to increase exercise adherence and promote the return to daily activities could extend the benefits of formal rehabilitation for patients who have suffered a hip fracture.
Specific Aims:
We will conduct a 5-year multi-site randomized controlled trial in patients who have suffered a recent hip fracture and have completed all rehabilitation services. The specific aim that this project will address is whether:
Participation in the Strong for Life (SFL) program will improve function and disability outcomes in participants 6-months after they are discharged from rehabilitation services.
This study will also investigate the following secondary hypotheses:
- Changes in function and disability at 6-month follow-up will be correlated with changes in all three proposed intermediary variables: muscle strength, balance, and self-efficacy.
- The SFL program will significantly improve health-related quality of life among participants at 6-month follow-up.
- At 9-month follow-up the SFL program will continue to have a significant impact on participants' function and disability compared to the control group.
Target population:
The target population will be people aged 60 years or more who have suffered a recent traumatic hip fracture, have one or more residual functional limitations and have completed all inpatient, outpatient or homecare rehabilitation services.
Intervention:
We will use an enhanced version of the Strong for Life program. This home-based exercise program will include both resistance exercises using Thera-bands that will be shown on a video/DVD and weight-bearing exercises that are progressed using a step and/or a weighted vest. A cognitive-behavioral program that is customized for people recovering from hip fracture is being developed that will focus on promoting exercise adherence, decreasing fear of falling and increasing the return to daily activities in the patient's home and community.
Design:
A randomized controlled clinical trial will be implemented to measure the efficacy of the Strong for Life program. An attention-control intervention will be provided to all participants assigned to the control group. The outcome evaluation points are:
- T0: baseline, at the point of discharge from formal rehabilitation;
- T2: 6-month outcome assessment
- T3: 9-month follow-up
Outcomes:
The primary outcomes will be function measured by both self-report (AM PAC) and physical performance measures (SPPB). Secondary outcomes include disability, self-efficacy, balance, strength, cognition, and reaction time. Adherence to the exercise program and adverse events will also be monitored.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Enhanced Strong for Life |
| cardiovascular education (attention control) | Placebo comparator | Behavioral: cardiovascular nutrition education |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Have a primary diagnosis of hip fracture;
- Aged 60 years and above;
- Have functional limitation (i.e., as determined by limitation in at least one of 9 functional tasks listed in the SF-36 physical function scale, excluding vigorous activities);
- Have recently been discharged from rehabilitation services;
- Be able to understand and communicate in English;
Key exclusion criteria (7 listed)
- Have serious cognitive deficits (i.e., a Mini-Mental State Examination score of less than 20)85;
- Have severe depression (i.e., a score of 20 or greater on the Geriatric Depression Scale)86;
- Have a terminal illness with survival expected to be less than 1 year;
- Have significant pulmonary or cardiovascular contraindications or pre-existing conditions that preclude participating in an exercise program;
- Legally blind;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enhanced Strong for LifeThe program contains 5 minutes of warm-up, 25 minutes of strengthening, and 5 minutes of cool-down exercises. The SFL program is contained on a 35 minute videotape. Subjects are instructed to increase resistance when they can perform 10 repetitions of a movement pattern without significant fatigue or loss of proper execution. Subjects are instructed to move within a comfortable range of motion. Participants will be taught the SFL program during two home visits conducted by a physical therapist. On the first visit, the exercise techniques will be taught, modified as needed based on individual needs and practiced as necessary until proper technique is attained. Each participant will be given written guidelines for how to progress resistance of the program, how to modify the exercises and how to complete bimonthly exercise calendars. | Behavioural | 1 |
| cardiovascular nutrition educationadministered as an attention control intervention using home visits, phone calls and mail-outs of information | Behavioural | cardiovascular education (attention control) |
Primary outcome
The specific aim that this project will address is whether: Participation in the SFL program will improve function and disability outcomes in participants 6-months after they are discharged from rehabilitation services.
Time frame: baseline, 6-month and 9-month follow up
performance based function is assessed using the Short Physical Performance Battery (SPPB) and self-reported function is assessed using the AM-PAC
2 secondary outcomes
Changes in function and disability at 6-month follow-up will be correlated with changes in all three proposed intermediary variables: muscle strength, balance, and self-efficacy.
Time frame: baseline, 6-month and 9-month follow up
At 9-month follow-up the SFL program will continue to have a significant impact on participants' function and disability compared to the control group.
Time frame: baseline, 6-month and 9-month follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2013.
- Derived from this study: PubMed 24549550Latham NK, Harris BA, Bean JF, Heeren T, Goodyear C, Zawacki S, Heislein DM, Mustafa J, Pardasaney P, Giorgetti M, Holt N, Goehring L, Jette AM. Effect of a home-based exercise program on functional recovery following rehabilitation after hip fracture: a randomized clinical trial. JAMA. 2014 Feb 19;311(7):700-8. doi: 10.1001/jama.2014.469.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alan M Jette, PhD principal investigator
Health & Disability Research Institute
Nancy Latham, PhD principal investigator
Health & Disability Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced Strong for Life and cardiovascular nutrition education in people with Hip Fracture and Disability, run by Boston University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The specific aim that this project will address is whether: Participation in the SFL program will improve function and disability outcomes in participants 6-months after they are discharged from rehabilitation services. (time frame: baseline, 6-month and 9-month follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00592813, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2013.