Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000436
Status:
COMPLETED
Last Update Posted:
2007-01-04
First Post:
2000-01-29
Brief Title:
Improving Functional Recovery After Hip Fracture
Sponsor:
National Institute of Arthritis and Musculoskeletal and Skin Diseases NIAMS
Organization:
National Institute of Arthritis and Musculoskeletal and Skin Diseases NIAMS
Study Overview
Official Title:
Self-Efficacy and High-Intensity Strength Training to Improve Postoperative Rehabilitation of Hip Fracture Patients
Status:
COMPLETED
Status Verified Date:
2001-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 ones 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NIAMS-013 | None | None | None |