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Vascular Occlusion and Rheumatoid Arthritis

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ClinicalTrials.gov Identifier: NCT01483157
Recruitment Status : Unknown
Verified February 2014 by Bruno Gualano, University of Sao Paulo.
Recruitment status was:  Recruiting
First Posted : December 1, 2011
Last Update Posted : February 28, 2014
Sponsor:
Information provided by (Responsible Party):
Bruno Gualano, University of Sao Paulo

Brief 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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Other: vascular occlusion with exercise trainig Other: high intensity resistance training Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Strength Training With Vascular Occlusion in Patients With Rheumatoid Arthritis: A Randomized Clinical Trial
Study Start Date : November 2011
Estimated Primary Completion Date : November 2015
Estimated Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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: no exercise training



Primary Outcome Measures :
  1. muscle strength [ Time Frame: twelve weeks ]

Secondary Outcome Measures :
  1. quality of life [ Time Frame: twelve weeks ]


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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Bruno Gualano, Professor, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01483157     History of Changes
Other Study ID Numbers: vascular occlusion and RA
First Posted: December 1, 2011    Key Record Dates
Last Update Posted: February 28, 2014
Last Verified: February 2014

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases