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Clinical Trials/NCT01622465
NCT01622465
Completed
Phase 2

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

University of Campinas, Brazil1 site in 1 country14 target enrollmentAugust 2011

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Osteoarthritis, Hip
Sponsor
University of Campinas, Brazil
Enrollment
14
Locations
1
Primary Endpoint
Change from baseline in hip function at three months
Status
Completed
Last Updated
11 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2011
End Date
April 2014
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University of Campinas, Brazil
Responsible Party
Principal Investigator
Principal Investigator

Mariana Katia Rampazo

Principal Investigator

University of Campinas, Brazil

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change from baseline in hip function at three months

Time Frame: Baseline and three months

Harris Hip Score (HHS) will be used to collect the data at baseline and at three months

Secondary Outcomes

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

Study Sites (1)

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