Rheumatoid ArthritisNCT01483157
Vascular Occlusion and Rheumatoid Arthritis
A study testing vascular occlusion with exercise trainig and high intensity resistance training in people with Rheumatoid Arthritis, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Resistance exercise plus vascular occlusion may induce greater improvements in strength and muscle mass resistance training alone. The investigators speculate this training strategy could be beneficial in patients with rheumatoid arthritis. Read more about this study
- Who is it for?
- Ages 30 to 70 years, women only
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- vascular occlusion with exercise trainig and high intensity resistance training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- Nov 2011to Nov 2015
- Phase
- Interventional
- 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 30 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- female with rheumatoid arthritis
- Disease activity scores > 2.6
- use of anti-TNF-alpha drugs for at least 8 weeks
Who cannot join
- BMD < 20 kg/m2
- fibromyalgia
- cardiovascular disease
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
University of Sao Paulo - School of Medicine - Clinical Hospital
São Paulo, São Paulo, 05403-010
Reynaldo Costa Rodrigues, PhD Student, 55 11 26618022, rcrodriguespt@yahoo.com.br
Ana Lucia Sa Pinto, PhD
About this study
Official title: Effects of Strength Training With Vascular Occlusion in Patients With Rheumatoid Arthritis: A Randomized Clinical Trial
Resistance exercise plus vascular occlusion may induce greater improvements in strength and muscle mass resistance training alone. The investigators speculate this training strategy could be beneficial in patients with rheumatoid arthritis.
- Conditions
- Rheumatoid Arthritis
- Being tested
- vascular occlusion with exercise trainig, high intensity resistance training
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vascular occlusion with exercise trainigOther
twelve weeks of resistance training with vascular occlusion twice a week
high intensity resistance trainingOther
twelve weeks of resistance training twice a week
| Study group | Role | What they receive |
|---|---|---|
| low intensity with vascular occlusion | Experimental | Not described Receives: Other: vascular occlusion with exercise trainig |
| high intensity resistance training | Experimental | Not described Receives: Other: high intensity resistance training |
| no exercise training | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
muscle strength
Measured: twelve weeks
Secondary outcomes (1)
quality of life
Measured: twelve weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2011 (estimated)
- Study startNov 2011
- Primary completionNov 2015 (estimated)
- Study completionNov 2015 (estimated)
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 Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bruno Gualano, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01483157
- Sponsor's protocol ID
- vascular occlusion and RA
- Status last verified
- Feb 2014
- First submitted
- 29 Nov 2011
- Last updated
- 28 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Rodrigues R, Ferraz RB, Kurimori CO, Guedes LK, Lima FR, de Sa-Pinto AL, Gualano B, Roschel H. Low-Load Resistance Training With Blood-Flow Restriction in Relation to Muscle Function, Mass, and Functionality in Women With Rheumatoid Arthritis. Arthritis Care Res (Hoboken). 2020 Jun;72(6):787-797. doi: 10.1002/acr.23911. Epub 2020 May 14.
PubMed 31033228
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Strength Training With Vascular Occlusion in Patients With Rheumatoid Arthritis: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01483157
- Acronym / sponsor ID
- vascular occlusion and RA
- Conditions
- Rheumatoid Arthritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Nov 2015 (estimated)
- Study completion
- Nov 2015 (estimated)
- First posted
- 1 Dec 2011 (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.
Resistance exercise plus vascular occlusion may induce greater improvements in strength and muscle mass resistance training alone. The investigators speculate this training strategy could be beneficial in patients with rheumatoid arthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| low intensity with vascular occlusion | Experimental | Other: vascular occlusion with exercise trainig |
| high intensity resistance training | Experimental | Other: high intensity resistance training |
| no exercise training | No intervention | – |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- female with rheumatoid arthritis
- Disease activity scores > 2.6
- use of anti-TNF-alpha drugs for at least 8 weeks
Key exclusion criteria (3 listed)
- BMD < 20 kg/m2
- fibromyalgia
- cardiovascular disease
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 |
|---|---|---|
| vascular occlusion with exercise trainigtwelve weeks of resistance training with vascular occlusion twice a week | Other | low intensity with vascular occlusion |
| high intensity resistance trainingtwelve weeks of resistance training twice a week | Other | high intensity resistance training |
Primary outcome
muscle strength
Time frame: twelve weeks
1 secondary outcome
quality of life
Time frame: twelve weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2014.
- Derived from this study: PubMed 31033228Rodrigues R, Ferraz RB, Kurimori CO, Guedes LK, Lima FR, de Sa-Pinto AL, Gualano B, Roschel H. Low-Load Resistance Training With Blood-Flow Restriction in Relation to Muscle Function, Mass, and Functionality in Women With Rheumatoid Arthritis. Arthritis Care Res (Hoboken). 2020 Jun;72(6):787-797. doi: 10.1002/acr.23911. Epub 2020 May 14.
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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.
University of Sao Paulo - School of Medicine - Clinical Hospital
São Paulo, Brazil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vascular occlusion with exercise trainig and high intensity resistance training in people with Rheumatoid Arthritis, run by University of Sao 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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 28 Feb 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
muscle strength (time frame: twelve weeks). 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 NCT01483157, 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 28 Feb 2014.