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

Primary Purpose

Osteoarthritis, Hip, Osteonecrosis

Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Ergometer cycling
Conventional exercises
Sponsored by
University of Campinas, Brazil
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Hip focused on measuring Hip arthroplasty, Aged, Rehabilitation, Exercise therapy

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital das Clínicas da Universidade Estadual de Campinas

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ergometer cycling

Conventional exercises

Arm Description

Patients will participate of the exercises program with ergometer cycling and conventional exercises.

Patients will participate only of the conventional exercises program.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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
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.

Full Information

First Posted
June 11, 2012
Last Updated
December 3, 2014
Sponsor
University of Campinas, Brazil
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1. Study Identification

Unique Protocol Identification Number
NCT01622465
Brief Title
Effect of Cycle Ergometer in the Rehabilitation of Elderly Patients With Total Hip Arthroplasty
Official Title
Effect of Cycle Ergometer in the Rehabilitation of Elderly Patients With Total Hip Arthroplasty: Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Campinas, Brazil

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Hip, Osteonecrosis
Keywords
Hip arthroplasty, Aged, Rehabilitation, Exercise therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ergometer cycling
Arm Type
Experimental
Arm Description
Patients will participate of the exercises program with ergometer cycling and conventional exercises.
Arm Title
Conventional exercises
Arm Type
Active Comparator
Arm Description
Patients will participate only of the conventional exercises program.
Intervention Type
Behavioral
Intervention Name(s)
Ergometer cycling
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Conventional exercises
Intervention Description
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
Primary Outcome Measure Information:
Title
Change from baseline in hip function at three months
Description
Harris Hip Score (HHS) will be used to collect the data at baseline and at three months
Time Frame
Baseline and three months
Secondary Outcome Measure Information:
Title
Change from baseline in physical performance of lower limbs at three months.
Description
"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.
Time Frame
Baseline and three months
Title
Change from baseline in health-related quality of life (HRQOL)at three months by generic questionnaire
Description
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
Time Frame
Baseline and three months
Title
Change from baseline in health-related quality of life (HRQOL) at three months by specific questionnaire
Description
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.
Time Frame
Baseline and three months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mariana K Rampazo, PhDCandidate
Organizational Affiliation
University of Campinas, Nursing Department
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Maria José D'Elboux, PhD
Organizational Affiliation
University of Campinas, Nursing Department
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital das Clínicas da Universidade Estadual de Campinas
City
Campinas
State/Province
São Paulo
ZIP/Postal Code
13083-887
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
25873151
Citation
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.
Results Reference
derived

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

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