Improving Functional Recovery After Hip Fracture NCT00000436

Clinical Trial Details — Status: Completed

Administrative data
NCT number	NCT00000436
Other study ID #	P60AR038520
Secondary ID	NIAMS-013
Status	Completed
Phase	Phase 3
First received	January 29, 2000
Last updated	January 2, 2007
Start date	July 1993
Est. completion date	June 2000

Study information
Verified date	March 2001
Source	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Contact	n/a
Is FDA regulated	No
Health authority	United States: Federal Government
Study type	Interventional

Clinical 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. The other group will participate in a program of patient education and strength training, including an at-home walking program.

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.

Recruitment information / eligibility
Status	Completed
Enrollment	200
Est. completion date	June 2000
Est. primary completion date
Accepts healthy volunteers	No
Gender	Both
Age group	65 Years and older
Eligibility	Inclusion Criteria: - 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. Exclusion Criteria: - 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Behavioral:
• Self-efficacy and muscle strength training

Procedure:
• High-intensity strength training

Locations
Country	Name	City	State
United States	Hospital for Special Surgery	New York	New York

Sponsors *(1)*
Lead Sponsor	Collaborator
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Country where clinical trial is conducted

United States,

References & Publications (3)

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. Review. — View Citation

Ruchlin 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. Review. — View Citation

Ruchlin 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. — View Citation

Improving Functional Recovery After Hip Fracture

Clinical Trial Details — Status: Completed

Administrative data

Study information