Completed

Self-Efficacy and High-Intensity Strength Training to Improve Postoperative Rehabilitation of Hip Fracture Patients

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What is being tested

Self-efficacy and muscle strength training

+ High-intensity strength training

BehavioralProcedure
Who is being recruted

Femoral Fractures+3

+ Leg Injuries

+ Wounds and Injuries

Over 65 Years
+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: July 1993
See protocol details

Summary

Principal SponsorNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Last updated: January 4, 2007
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 1993

Actual date on which the first participant was enrolled.

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.

NCT00000436
Principal SponsorNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Last updated: January 4, 2007
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

200 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Femoral FracturesLeg InjuriesWounds and InjuriesHip InjuriesFractures, BoneHip Fractures

Criteria

1 inclusion criteria required to participate
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

6 exclusion criteria prevent from participating
Patients and physicians who refuse to participate or who intend to relocate upon discharge

Patients for whom exercise is contraindicated or whose physicians believe that exercise is contraindicated

Patients who are unable to give informed consent on the 4th or 5th day after surgery

Patients who do not have access to a telephone or cannot be reached by telephone

Show More Criteria

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Hospital for Special Surgery

New York, United StatesOpen Hospital for Special Surgery in Google Maps
CompletedOne Study Center
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