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

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

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.

Study Overview

• Status: Completed
• Conditions: Osteonecrosis; Osteoarthritis, Hip
• Intervention / Treatment: Behavioral: Ergometer cycling; Behavioral: Conventional exercises

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 Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 2

Contacts and Locations

Study Locations

• Brazil
  • São Paulo
    • Campinas, São Paulo, Brazil, 13083-887
      • Hospital das Clínicas da Universidade Estadual de Campinas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ergometer cycling; Patients will participate of the exercises program with ergometer cycling and conventional exercises.	Behavioral: Ergometer cycling; 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
Active Comparator: Conventional exercises; Patients will participate only of the conventional exercises program.	Behavioral: Conventional exercises; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Campinas, Brazil
• Investigators: Principal Investigator: Mariana K Rampazo, PhDCandidate, University of Campinas, Nursing Department; Study Chair: Maria José D'Elboux, PhD, University of Campinas, Nursing Department

Publications and helpful links

General Publications

• Rampazo-Lacativa MK, D'Elboux MJ. Effect of cycle ergometer and conventional exercises on rehabilitation of older patients with total hip arthroplasty: study protocol for randomized controlled trial. Trials. 2015 Apr 8;16:139. doi: 10.1186/s13063-015-0647-8.

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: June 11, 2012
• First Submitted That Met QC Criteria: June 14, 2012
• First Posted (Estimate): June 19, 2012

Study Record Updates

• Last Update Posted (Estimate): December 4, 2014
• Last Update Submitted That Met QC Criteria: December 3, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: Rehabilitation; Aged; Hip arthroplasty; Exercise therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Bone Diseases; Osteoarthritis; Osteoarthritis, Hip; Osteonecrosis
• Other Study ID Numbers: 403/2011