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

NCT ID: NCT01622465

Last Updated: 2014-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2014-04-30

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.

Conditions

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Osteoarthritis, Hip Osteonecrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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Ergometer cycling

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

Group Type EXPERIMENTAL

Ergometer cycling

Intervention Type BEHAVIORAL

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

Conventional exercises

Patients will participate only of the conventional exercises program.

Group Type ACTIVE_COMPARATOR

Conventional exercises

Intervention Type BEHAVIORAL

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

Interventions

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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

Intervention Type 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

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Campinas, Brazil

OTHER

Sponsor Role lead

Responsible Party

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Mariana Katia Rampazo

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mariana K Rampazo, PhDCandidate

Role: PRINCIPAL_INVESTIGATOR

University of Campinas, Nursing Department

Maria José D'Elboux, PhD

Role: STUDY_CHAIR

University of Campinas, Nursing Department

Locations

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Hospital das Clínicas da Universidade Estadual de Campinas

Campinas, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type DERIVED
PMID: 25873151 (View on PubMed)

Other Identifiers

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403/2011

Identifier Type: -

Identifier Source: org_study_id