Osteoarthritis, HipPhase 2NCT01622465
Effect of Cycle Ergometer in the Rehabilitation of Elderly Patients With Total Hip Arthroplasty
A Phase 2 study testing Ergometer cycling and Conventional exercises in people with Osteoarthritis, Hip and Osteonecrosis, run by University of Campinas, Brazil at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Osteoarthritis, Hip, Osteonecrosis
- What is being tested?
- Ergometer cycling and Conventional exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2011to Apr 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital das Clínicas da Universidade Estadual de Campinas
Campinas, São Paulo, 13083-887
About this study
Official title: Effect of Cycle Ergometer in the Rehabilitation of Elderly Patients With Total Hip Arthroplasty: Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Osteoarthritis, Hip, Osteonecrosis
- Being tested
- Ergometer cycling, Conventional exercises
- Keywords
- Hip arthroplasty, Aged, Rehabilitation, Exercise therapy
- Medical subject headings
- Osteoarthritis, Hip, Osteonecrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ergometer cyclingBehavioural
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 exercisesBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Ergometer cycling | Experimental | Patients will participate of the exercises program with ergometer cycling and conventional exercises. Receives: Behavioral: Ergometer cycling |
| Conventional exercises | Active comparator | Patients will participate only of the conventional exercises program. Receives: Behavioral: Conventional exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline and three months
Secondary outcomes (3)
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.
Measured: Baseline and three months
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
Measured: Baseline and three months
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.
Measured: Baseline and three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2012 (estimated)
- Study startAug 2011
- Primary completionDec 2013
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, HipStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Campinas, Brazil
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariana Katia Rampazo, University of Campinas, Brazil
- Investigators
- Mariana K Rampazo, PhDCandidate, Principal investigator, University of Campinas, Nursing DepartmentMaria José D'Elboux, PhD, Study chair, University of Campinas, Nursing Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01622465
- Sponsor's protocol ID
- 403/2011
- Status last verified
- Dec 2014
- First submitted
- 11 Jun 2012
- Last updated
- 4 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25873151
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cycle Ergometer in the Rehabilitation of Elderly Patients With Total Hip Arthroplasty: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01622465
- Acronym / sponsor ID
- 403/2011
- Conditions
- Osteoarthritis, Hip, Osteonecrosis
- Keywords
- Hip arthroplasty, Aged, Rehabilitation, Exercise therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of Campinas, BrazilUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 19 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ergometer cycling | Experimental | Behavioral: Ergometer cyclingPatients will participate of the exercises program with ergometer cycling and conventional exercises. |
| Conventional exercises | Active comparator | Behavioral: Conventional exercisesPatients will participate only of the conventional exercises program. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ergometer cyclingPatients 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 | Behavioural | Ergometer cycling |
| Conventional exercisesPatients 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 | Behavioural | Conventional exercises |
Primary outcome
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
3 secondary outcomes
Change from baseline in physical performance of lower limbs at three months.
Time frame: Baseline and three months
Change from baseline in health-related quality of life (HRQOL)at three months by generic questionnaire
Time frame: Baseline and three months
Change from baseline in health-related quality of life (HRQOL) at three months by specific questionnaire
Time frame: Baseline and three months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2014.
- Derived from this study: PubMed 25873151Rampazo-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mariana K Rampazo, PhDCandidate principal investigator
University of Campinas, Nursing Department
Maria José D'Elboux, PhD study chair
University of Campinas, Nursing Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ergometer cycling and Conventional exercises in people with Osteoarthritis, Hip and Osteonecrosis, run by University of Campinas, Brazil at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in hip function at three months (time frame: Baseline and three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01622465, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2014.