Rheumatoid ArthritisPhase 4NCT02219022
Progressive Resistance Exercise in Rheumatoid Arthritis
A Phase 4 study testing Experimental group in people with Rheumatoid Arthritis, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
A randomized controlled trial with rheumatoid arthritis patients will be realized. Patients will be randomized into two groups. Experimental group will do a 12 weeks training of progressive resistance exercise for global muscles and remain with the clinical treatment and the control only remain with the clinical… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Experimental group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2011to Oct 2015
- Phase
- Phase 4
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Rheumatoid arthritis according to American College of Rheumatology 2010
- Both genders
- Age between 18 and 65 years
- Functional class I, II and III
- Stable medication within the three months preceding the study
- Haven't done any kind of regular exercise (two or more times per Week) for at least three months before study start
- Have agreed to participate in the study and signed an informed consent form.
Who cannot join
- Participating in another type of study
- Have difficulty understanding the evaluation tools with fibromyalgia
- Joint deformities that make impossible do the exercises
- Other musculoskeletal diseases
- Other diseases that contraindicate exercises.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Progressive Resistance Exercise in Rheumatoid Arthritis Patients: a Randomized Controlled Trial
A randomized controlled trial with rheumatoid arthritis patients will be realized. Patients will be randomized into two groups. Experimental group will do a 12 weeks training of progressive resistance exercise for global muscles and remain with the clinical treatment and the control only remain with the clinical treatment. Patients will be evaluated at baseline, after 6, 12 and 24 weeks.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Control group, Experimental group
- Keywords
- Rheumatoid arthritis, Progressive resistance exercise, Pain, Functional capacity, Quality of life, Muscle strength
- Medical subject headings
- Arthritis, Rheumatoid, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control groupOther
Also called Clinical tretament
Experimental groupOther
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Patient remain with their usual clinical treatment. Receives: Other: Control group |
| Experimental group | Experimental | Patients in experimental group participated in a 12-week progressive resistance training using a maximum repetition exercise in which patients performed 1 Maximum Repetition with the maximum bearable weight. Once the 1 Maximum Repetitionwas determined, training was divided into the following regimen: 2 series of 8 repetitions, the first with 50% and the second with 70% of 1 Maximum Repetition.
The exercises were knee extension and flexion and hip abduction and adduction, elbow extension and flexion, wrist extension and flexion and shoulder abduction and adduction and spine extension and flexion all performed in machines. The 1 Maximum Repetition load was reevaluated every 6 weeks.
Patient remain with their usual clinical treatment. Receives: Other: Control group; Other: Experimental group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain - Visual analogue scale
Measured: baseline, 6, 12 and 24 weeks
Secondary outcomes (3)
Change in function capacity - Health Assessment questionaire
Measured: Baseline, after 6, 12 and 24 weeks
Change in quality of life - Short form 36
Measured: baseline, after 6, 12 and 24 weeks
Change in strength - 1 maximum repetition
Measured: baseline, after 6, 12 and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2014 (estimated)
- Study startJul 2011
- Primary completionJun 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Felipe Martinelli Lourenzi, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02219022
- Sponsor's protocol ID
- CEP/UNIFESP 1826/10
- Status last verified
- Aug 2016
- First submitted
- 13 Aug 2014
- Last updated
- 15 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Progressive Resistance Exercise in Rheumatoid Arthritis Patients: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02219022
- Acronym / sponsor ID
- CEP/UNIFESP 1826/10
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid arthritis, Progressive resistance exercise, Pain, Functional capacity, Quality of life, Muscle strength
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Jul 2011
- Primary completion
- Jun 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 18 Aug 2014 (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.
A randomized controlled trial with rheumatoid arthritis patients will be realized. Patients will be randomized into two groups. Experimental group will do a 12 weeks training of progressive resistance exercise for global muscles and remain with the clinical treatment and the control only remain with the clinical treatment. Patients will be evaluated at baseline, after 6, 12 and 24 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: Control groupPatient remain with their usual clinical treatment. |
| Experimental group | Experimental | Other: Control group, Other: Experimental groupPatients in experimental group participated in a 12-week progressive resistance training using a maximum repetition exercise in which patients performed 1 Maximum Repetition with the maximum bearable weight. Once the 1 Maximum Repetitionwas determined, training was divided into the following regimen: 2 series of 8 repetitions, the first with 50% and the second with 70% of 1 Maximum Repetition. The exercises were knee extension and flexion and hip abduction and adduction, elbow extension and flexion, wrist extension and flexion and shoulder abduction and adduction and spine extension and flexion all performed in machines. The 1 Maximum Repetition load was reevaluated every 6 weeks. Patient remain with their usual clinical treatment. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Rheumatoid arthritis according to American College of Rheumatology 2010
- Both genders
- Age between 18 and 65 years
- Functional class I, II and III
- Stable medication within the three months preceding the study
Key exclusion criteria (5 listed)
- Participating in another type of study
- Have difficulty understanding the evaluation tools with fibromyalgia
- Joint deformities that make impossible do the exercises
- Other musculoskeletal diseases
- Other diseases that contraindicate exercises.
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 |
|---|---|---|
| Control groupAlso: Clinical tretament | Other | Control group, Experimental group |
| Experimental group | Other | Experimental group |
Primary outcome
Change in pain - Visual analogue scale
Time frame: baseline, 6, 12 and 24 weeks
3 secondary outcomes
Change in function capacity - Health Assessment questionaire
Time frame: Baseline, after 6, 12 and 24 weeks
Change in quality of life - Short form 36
Time frame: baseline, after 6, 12 and 24 weeks
Change in strength - 1 maximum repetition
Time frame: baseline, after 6, 12 and 24 weeks
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 15 Aug 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Experimental group in people with Rheumatoid Arthritis, run by Federal University of São Paulo 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 7 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 15 Aug 2016. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 in pain - Visual analogue scale (time frame: baseline, 6, 12 and 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Aug 2016; AzTrials last refreshed its copy on 1 Nov 2026.