Vascular Occlusion and Rheumatoid Arthritis
This study is currently recruiting participants.
Verified November 2011 by University of Sao Paulo
Sponsor:
University of Sao Paulo
Information provided by (Responsible Party):
Bruno Gualano, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01483157
First received: November 29, 2011
Last updated: November 30, 2011
Last verified: November 2011
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Rheumatoid Arthritis |
Other: vascular occlusion with exercise trainig Other: high intensity resistance training Other: control |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Effects of Strength Training With Vascular Occlusion in Patients With Rheumatoid Arthritis: A Randomized Clinical Trial |
Resource links provided by NLM:
Further study details as provided by University of Sao Paulo:
Primary Outcome Measures:
- muscle strength [ Time Frame: twelve weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- quality of life [ Time Frame: twelve weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 30 |
| Study Start Date: | November 2011 |
| Estimated Study Completion Date: | November 2013 |
| Estimated Primary Completion Date: | November 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: low intensity with vascular occlusion |
Other: vascular occlusion with exercise trainig
twelve weeks of resistance training with vascular occlusion twice a week
|
| Experimental: high intensity resistance training |
Other: high intensity resistance training
twelve weeks of resistance training twice a week
|
| No Intervention: control |
Other: control
no exercise
|
Eligibility| Ages Eligible for Study: | 30 Years to 70 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- female with rheumatoid arthritis
- Disease activity scores > 2.6
- use of anti-TNF-alpha drugs for at least 8 weeks
Exclusion Criteria:
- BMD < 20 kg/m2
- fibromyalgia
- cardiovascular disease
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01483157
Locations
| Brazil | |
| University of Sao Paulo - School of Medicine - Clinical Hospital | Recruiting |
| Sao Paulo, Brazil, 05403-010 | |
| Contact: Reynaldo Costa Rodrigues, PhD Student 55 11 26618022 rcrodriguespt@yahoo.com.br | |
| Principal Investigator: Ana Lucia Sa Pinto, PhD | |
| Sub-Investigator: Lissiane Noronha Guedes, MD | |
| Sub-Investigator: Bruno Gualano, PhD | |
Sponsors and Collaborators
University of Sao Paulo
More Information
No publications provided
| Responsible Party: | Bruno Gualano, Professor, University of Sao Paulo |
| ClinicalTrials.gov Identifier: | NCT01483157 History of Changes |
| Other Study ID Numbers: | vascular occlusion and RA |
| Study First Received: | November 29, 2011 |
| Last Updated: | November 30, 2011 |
| Health Authority: | Brazil: National Committee of Ethics in Research |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases |
Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |
ClinicalTrials.gov processed this record on June 18, 2013