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Completed

NCT Number: NCT01622465

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

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.

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Key information

Conditions

Osteoarthritis, Hip Arthritis Bone Diseases Joint Diseases Musculoskeletal Diseases Necrosis Osteoarthritis Osteonecrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Rheumatic Diseases

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hospital das Clínicas da Universidade Estadual de Campinas

Campinas, São Paulo, 13083-887, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ergometer Cycling

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

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

Primary outcomes

  1. 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

  1. Change from baseline in physical performance of lower limbs at three months.

    Time frame: Baseline and 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.

  2. Change from baseline in health-related quality of life (HRQOL)at three months by generic questionnaire

    Time frame: Baseline and three months

    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

  3. Change from baseline in health-related quality of life (HRQOL) at three months by specific questionnaire

    Time frame: Baseline and three months

    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.

Sponsors and collaborators

Lead sponsor

University of Campinas, Brazil

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Jun 19, 2012
Registry last updated
Dec 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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