Clinical trial NCT01622465: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteoarthritis, Hip
Osteonecrosis
Keywords: Hip arthroplasty
Aged
Rehabilitation
Exercise therapy
Lead sponsor: University of Campinas, Brazil
Sponsor class: OTHER
First posted: 2012-06-19
Enrollment: 14
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change from baseline in hip function at three months
timeFrame: Baseline and three months
Secondary outcomes:
measure: Change from baseline in physical performance of lower limbs at three months.
timeFrame: Baseline and three months
measure: Change from baseline in health-related quality of life (HRQOL)at three months by generic questionnaire
timeFrame: Baseline and three months
measure: Change from baseline in health-related quality of life (HRQOL) at three months by specific questionnaire
timeFrame: Baseline and three months
Other outcomes:
Locations:
city: Campinas
country: Brazil
facility: Hospital das Clínicas da Universidade Estadual de Campinas
state: São Paulo
Study officials:
affiliation: University of Campinas, Nursing Department
name: Mariana K Rampazo, PhDCandidate
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Campinas, Nursing Department
name: Maria José D'Elboux, PhD
role: STUDY_CHAIR
References:
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.