Unilateral Hip FracturePhase 3NCT00000436
Improving Functional Recovery After Hip Fracture
A Phase 3 study testing Self-efficacy and muscle strength training and High-intensity strength training in people with Unilateral Hip Fracture, run by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) at 1 site in United States.
Trial summary
This project will assess the effectiveness of a novel approach involving patient education and strength training to improve functional recovery after a hip fracture. Participants will be randomly assigned to one of two study groups. One group (control group) will receive standard medical care. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Unilateral Hip Fracture
- What is being tested?
- Self-efficacy and muscle strength training and High-intensity strength training
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 1993to Jun 2000
- Phase
- Phase 3
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients who are 65 years of age and older, and who have been admitted for a hip fracture to the Fracture Service at New York Presbyterian Hospital.
Who cannot join
- Patients who are unable to give informed consent on the 4th or 5th day after surgery.
- Patients whose hip fracture is due to underlying disease, secondary to malignancy (cancer).
- Patients who do not speak English.
- Patients for whom exercise is contraindicated or whose physicians believe that exercise is contraindicated.
- Patients who do not have access to a telephone or cannot be reached by telephone.
- Patients and physicians who refuse to participate or who intend to relocate upon discharge.
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital for Special Surgery
New York, New York, 10021
About this study
Official title: Self-Efficacy and High-Intensity Strength Training to Improve Postoperative Rehabilitation of Hip Fracture Patients
This project will assess the effectiveness of a novel approach involving patient education and strength training to improve functional recovery after a hip fracture. Participants will be randomly assigned to one of two study groups. One group (control group) will receive standard medical care. The other group will participate in a program of patient education and strength training, including an at-home walking program.
Read the detailed description
The specific aims of this project are to (a) implement an intervention program of patient education focused on self-efficacy (the belief that one's actions are responsible for successful outcomes) and strength training designed to improve the postoperative rehabilitation of older persons (65 years of age and older) who have sustained a fracture of the hip; and (b) evaluate in a randomized trial the efficacy of this intervention program to improve the overall postoperative functional status of such patients and decrease the rate of their subsequent institutionalization.
The study will also (a) describe and document the risk factors for functional deterioration, recurrent falls, and subsequent institutionalization in a cohort of such patients; (b) assess self-efficacy beliefs and their ability to influence and predict postoperative functional capacity in such patients; and (c) document the costs associated with implementing the program and generate data that can provide the basis for subsequent cost-benefit analysis.
We hypothesize that (a) a program of patient education focusing on self-efficacy and strength training can improve the functional capacity and reduce the rate of institutionalization of older persons following hip fracture; and (b) clinical, psychosocial factors, muscle strength, and balance are multifactorial determinants of functional capacity, recurrent falls, and subsequent institutionalization in hip fracture patients.
We will randomize 200 patients who have sustained a primary unilateral hip fracture to the multiple-component intervention program of patient education and high-intensity strength training or to standard medical care. The intervention program will comprise four major components: (1) an in-hospital postoperative patient instruction protocol conducted prior to discharge with the patient and a family member or caregiver; (2) a hospital-based, 8-week program of high-intensity isokinetic strength training for patients; (3) an at-home walking program designed to enable patients to maintain strength and physical activity following the hospital-based portion of the intervention; and (4) supportive telephone calls through which patients and their families or caregivers will have regular and ongoing contact with a hospital-based interventionist, as well as other hip fracture patients.
The principal outcome is within-patient change in the physical, social, and role function subscales of the SF-36. Secondary measures of outcome, including muscle strength, balance, functional status on the Cummings Scale, activities of daily living, recurrent falls, and rate of institutionalization, will be assessed at baseline and 1 year post-discharge.
The long-term objective of the project is to improve the overall functional capacity and reduce both recurrent falls and the need for institutionalization of hip fracture patients through development and evaluation of an intervention program whose feasibility and cost have the potential for application in a wide range of institutional settings involved in the treatment and rehabilitation of such patients.
- Conditions
- Unilateral Hip Fracture
- Being tested
- Self-efficacy and muscle strength training, High-intensity strength training
- Keywords
- Hip fracture, Self-efficacy, Strength training, Rehabilitation, Postoperative
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-efficacy and muscle strength trainingBehavioural
High-intensity strength trainingProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2000 (estimated)
- Study startJul 1993
- Study completionJun 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Unilateral Hip FractureStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Sponsor type
- US National Institutes of Health
- Investigators
- John P. Allegrante, PhD, Principal investigator, Hospital for Special Surgery, New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000436
- Sponsor's protocol ID
- P60AR038520
- Other IDs
- NIAMS-013
- Status last verified
- Mar 2001
- First submitted
- 29 Jan 2000
- Last updated
- 4 Jan 2007
- Results posted
- No
Publications
Allegrante JP, MacKenzie CR, Robbins L, Cornell CN. Hip fracture in older persons. Does self-efficacy-based intervention have a role in rehabilitation? Arthritis Care Res. 1991 Mar;4(1):39-47. doi: 10.1002/art.1790040108.
PubMed 11188586Ruchlin HS, Allegrante JP, Einstein J, O'Doherty J, Robbins L, Peterson MG, MacKenzie CR, Cornell CN. A method for documenting the economic efficacy of multiple-component interventions designed to enhance functional and social status. Arthritis Care Res. 1997 Apr;10(2):151-8. doi: 10.1002/art.1790100210. No abstract available.
PubMed 9313403Ruchlin HS, Elkin EB, Allegrante JP. The economic impact of a multifactorial intervention to improve postoperative rehabilitation of hip fracture patients. Arthritis Rheum. 2001 Oct;45(5):446-52. doi: 10.1002/1529-0131(200110)45:53.0.co;2-r.
PubMed 11642644Handoll HH, Cameron ID, Mak JC, Panagoda CE, Finnegan TP. Multidisciplinary rehabilitation for older people with hip fractures. Cochrane Database Syst Rev. 2021 Nov 12;11(11):CD007125. doi: 10.1002/14651858.CD007125.pub3.
PubMed 34766330
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-Efficacy and High-Intensity Strength Training to Improve Postoperative Rehabilitation of Hip Fracture Patients
- ClinicalTrials.gov ID
- NCT00000436
- Acronym / sponsor ID
- P60AR038520
- Conditions
- Unilateral Hip Fracture
- Keywords
- Hip fracture, Self-efficacy, Strength training, Rehabilitation, Postoperative
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants
- Lead sponsor
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)US National Institutes of Health
- Study start
- Jul 1993
- Study completion
- Jun 2000
- First posted
- 31 Jan 2000 (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.
This project will assess the effectiveness of a novel approach involving patient education and strength training to improve functional recovery after a hip fracture. Participants will be randomly assigned to one of two study groups. One group (control group) will receive standard medical care. The other group will participate in a program of patient education and strength training, including an at-home walking program.
Detailed description
The specific aims of this project are to (a) implement an intervention program of patient education focused on self-efficacy (the belief that one's actions are responsible for successful outcomes) and strength training designed to improve the postoperative rehabilitation of older persons (65 years of age and older) who have sustained a fracture of the hip; and (b) evaluate in a randomized trial the efficacy of this intervention program to improve the overall postoperative functional status of such patients and decrease the rate of their subsequent institutionalization.
The study will also (a) describe and document the risk factors for functional deterioration, recurrent falls, and subsequent institutionalization in a cohort of such patients; (b) assess self-efficacy beliefs and their ability to influence and predict postoperative functional capacity in such patients; and (c) document the costs associated with implementing the program and generate data that can provide the basis for subsequent cost-benefit analysis.
We hypothesize that (a) a program of patient education focusing on self-efficacy and strength training can improve the functional capacity and reduce the rate of institutionalization of older persons following hip fracture; and (b) clinical, psychosocial factors, muscle strength, and balance are multifactorial determinants of functional capacity, recurrent falls, and subsequent institutionalization in hip fracture patients.
We will randomize 200 patients who have sustained a primary unilateral hip fracture to the multiple-component intervention program of patient education and high-intensity strength training or to standard medical care. The intervention program will comprise four major components: (1) an in-hospital postoperative patient instruction protocol conducted prior to discharge with the patient and a family member or caregiver; (2) a hospital-based, 8-week program of high-intensity isokinetic strength training for patients; (3) an at-home walking program designed to enable patients to maintain strength and physical activity following the hospital-based portion of the intervention; and (4) supportive telephone calls through which patients and their families or caregivers will have regular and ongoing contact with a hospital-based interventionist, as well as other hip fracture patients.
The principal outcome is within-patient change in the physical, social, and role function subscales of the SF-36. Secondary measures of outcome, including muscle strength, balance, functional status on the Cummings Scale, activities of daily living, recurrent falls, and rate of institutionalization, will be assessed at baseline and 1 year post-discharge.
The long-term objective of the project is to improve the overall functional capacity and reduce both recurrent falls and the need for institutionalization of hip fracture patients through development and evaluation of an intervention program whose feasibility and cost have the potential for application in a wide range of institutional settings involved in the treatment and rehabilitation of such patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Patients who are 65 years of age and older, and who have been admitted for a hip fracture to the Fracture Service at New York Presbyterian Hospital.
Key exclusion criteria (6 listed)
- Patients who are unable to give informed consent on the 4th or 5th day after surgery.
- Patients whose hip fracture is due to underlying disease, secondary to malignancy (cancer).
- Patients who do not speak English.
- Patients for whom exercise is contraindicated or whose physicians believe that exercise is contraindicated.
- Patients who do not have access to a telephone or cannot be reached by telephone.
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 |
|---|---|---|
| Self-efficacy and muscle strength training | Behavioural | – |
| High-intensity strength training | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
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 4 Jan 2007.
- Background: PubMed 11188586Allegrante JP, MacKenzie CR, Robbins L, Cornell CN. Hip fracture in older persons. Does self-efficacy-based intervention have a role in rehabilitation? Arthritis Care Res. 1991 Mar;4(1):39-47. doi: 10.1002/art.1790040108.
- Background: PubMed 9313403Ruchlin HS, Allegrante JP, Einstein J, O'Doherty J, Robbins L, Peterson MG, MacKenzie CR, Cornell CN. A method for documenting the economic efficacy of multiple-component interventions designed to enhance functional and social status. Arthritis Care Res. 1997 Apr;10(2):151-8. doi: 10.1002/art.1790100210. No abstract available.
- Background: PubMed 11642644Ruchlin HS, Elkin EB, Allegrante JP. The economic impact of a multifactorial intervention to improve postoperative rehabilitation of hip fracture patients. Arthritis Rheum. 2001 Oct;45(5):446-52. doi: 10.1002/1529-0131(200110)45:53.0.co;2-r.
- Derived from this study: PubMed 34766330Handoll HH, Cameron ID, Mak JC, Panagoda CE, Finnegan TP. Multidisciplinary rehabilitation for older people with hip fractures. Cochrane Database Syst Rev. 2021 Nov 12;11(11):CD007125. doi: 10.1002/14651858.CD007125.pub3.
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.
John P. Allegrante, PhD principal investigator
Hospital for Special Surgery, New York
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Self-efficacy and muscle strength training and High-intensity strength training in people with Unilateral Hip Fracture, run by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) 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 1 inclusion and 6 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 4 Jan 2007. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00000436, which also lists 4 linked publications.
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 4 Jan 2007.