Effect of Cycle Ergometer in the Rehabilitation of Elderly Patients With Total Hip Arthroplasty

Study Overview
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Brief Summary
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The aim of this study is to evaluate the effects of an exercise program with a cycle ergometer in functional outcome and related-health quality of life (RHQL) in elderly patients with total hip arthroplasty.

Detailed Description
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Behavioral: Ergometer Cycling Ergometer Cycling under the guidance of a physical therapist after the second postoperative week. These training sessions were scheduled to be performed two times a week for a time period of at least eith weeks. Behavioral: No ergometer cycling Patients of the no ergometer cycling group did not receive any ergometer cycling after surgery, only conventional exercises.

Official Title
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Effect of Cycle Ergometer in the Rehabilitation of Elderly Patients With Total Hip Arthroplasty: Randomized Controlled Trial

Conditions
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Osteoarthritis, Hip, Osteonecrosis

Intervention / Treatment
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* Behavioral: Ergometer cycling
* Behavioral: Conventional exercises


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged patients (60 years or more) of both sexes Being submitted to the total hip arthroplasty, primary and unilateral, for hip osteoarthritis or hip osteonecrosis no history of physical therapy two months before surgery Exclusion Criteria: arthroplasty of hip fracture or other condition; neurological disease that compromises motor function; postoperative complications (dislocation, infection, cardiovascular events); revision of the prosthesis; patients who are unable to attend the sessions of physical therapy or refused to participate in the study

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ergometer cycling<br>Patients will participate of the exercises program with ergometer cycling and conventional exercises. | Behavioral: Ergometer cycling<br>* Patients will participate of the exercises program with ergometer cycling and conventional exercises. The program will initiate after two weeks of the postoperative and will continue until three months of the postoperative<br>|
| Active Comparator: Conventional exercises<br>Patients will participate only of the conventional exercises program. | Behavioral: Conventional exercises<br>* Patients will participate only of the conventional exercises program. The program will initiate after two weeks of the postoperative and will continue until three months of the postoperative<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in hip function at three months | Harris Hip Score (HHS) will be used to collect the data at baseline and at three months | Baseline and three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in physical performance of lower limbs at three months. | Short Physical Performance Battery (SPPB) developed by Guralnik (1994), to evaluate of balance, gait speed and muscle strenght, of lower limbs will be used to collect the data at baseline and at three months. | Baseline and three months | 
| Change from baseline in health-related quality of life (HRQOL)at three months by generic questionnaire | The generic questionnaire evaluation HRQOL Medical Outcomes Survey 36 - Item Short-Form developed by Ware and Sherboune (1992) will be used to collect the data at baseline and at three months | Baseline and three months | 
| Change from baseline in health-related quality of life (HRQOL) at three months by specific questionnaire | The specific questionnaire evaluattion HRQOL Western Ontario and McMaster Universities (WOMAC) developed by Bellamy (1988) will be used to collect the data at baseline and at three months. | Baseline and three months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hip arthroplasty, Aged, Rehabilitation, Exercise therapy