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

Osteoarthritis, Hip Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01622465
• Other study ID #: 403/2011
• Status: Completed
• Phase: Phase 2
• First received: June 11, 2012
• Last updated: December 3, 2014
• Start date: August 2011
• Est. completion date: April 2014

Study information

• Verified date: December 2014
• Source: University of Campinas, Brazil
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: April 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis, Hip
• Osteonecrosis

Intervention

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
• 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

Locations

Country	Name	City	State
Brazil	Hospital das Clínicas da Universidade Estadual de Campinas	Campinas	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Campinas, Brazil

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes