NCT01622465

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Aug 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 11, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 19, 2012

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

December 4, 2014

Status Verified

December 1, 2014

Enrollment Period

2.3 years

First QC Date

June 11, 2012

Last Update Submit

December 3, 2014

Conditions

Osteoarthritis, HipOsteonecrosis

Keywords

Hip arthroplastyAgedRehabilitationExercise therapy

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

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

    Baseline and three months

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

    Baseline and three months

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

    Baseline and three months

Study Arms (2)

Ergometer cycling

EXPERIMENTAL

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

Behavioral: Ergometer cycling

Conventional exercises

ACTIVE COMPARATOR

Patients will participate only of the conventional exercises program.

Behavioral: Conventional exercises

Interventions

Ergometer cyclingBEHAVIORAL

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

Ergometer cycling
Conventional exercisesBEHAVIORAL

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

Conventional exercises

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital das Clínicas da Universidade Estadual de Campinas

Campinas, São Paulo, 13083-887, Brazil

Location

Related Publications (1)

  • 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.

    PMID: 25873151DERIVED

MeSH Terms

Conditions

Osteoarthritis, HipOsteonecrosis

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesBone DiseasesNecrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Mariana K Rampazo, PhDCandidate

    University of Campinas, Nursing Department

    PRINCIPAL INVESTIGATOR

  • Maria José D'Elboux, PhD

    University of Campinas, Nursing Department

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 11, 2012

First Posted

June 19, 2012

Study Start

August 1, 2011

Primary Completion

December 1, 2013

Study Completion

April 1, 2014

Last Updated

December 4, 2014

Record last verified: 2014-12

Locations

BR(1)