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

Phase 2

Completed

• Conditions: Osteoarthritis, Hip; Osteonecrosis
• Interventions: Behavioral: Ergometer cycling; Behavioral: Conventional exercises

• Registration Number: NCT01622465
• Lead Sponsor: University of Campinas, Brazil

Brief Summary

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

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.

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2012-06-11
• Study First Submitted QC: 2012-06-14
• Study First Posted: 2012-06-19
• Primary Completion: 2013-12
• Study Completion: 2014-04
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-03
• Last Update Posted: 2014-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ergometer cycling	Ergometer cycling	Patients will participate of the exercises program with ergometer cycling and conventional exercises.
Conventional exercises	Conventional exercises	Patients will participate only of the conventional exercises program.

Primary Outcome Measures

Name	Time	Method
Change from baseline in hip function at three months	Baseline and three months	Harris Hip Score (HHS) will be used to collect the data at baseline and at three months

Secondary Outcome Measures

Name	Time	Method
Change from baseline in health-related quality of life (HRQOL)at three months by generic questionnaire	Baseline and three months	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
Change from baseline in health-related quality of life (HRQOL) at three months by specific questionnaire	Baseline and three months	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.
Change from baseline in physical performance of lower limbs at three months.	Baseline and 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.

Trial Locations

Locations (1)

Hospital das Clínicas da Universidade Estadual de Campinas; 🇧🇷 Campinas, São Paulo, Brazil