Unilateral Hip Fracture Clinical Trial
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.
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Treatment