Vascular Occlusion and Rheumatoid Arthritis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2014 by University of Sao Paulo.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Bruno Gualano, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01483157
First received: November 29, 2011
Last updated: February 27, 2014
Last verified: February 2014
  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

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 2015
Estimated Primary Completion Date: November 2015 (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: no exercise training

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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: February 27, 2014
Health Authority: Brazil: National Committee of Ethics in Research

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

ClinicalTrials.gov processed this record on May 26, 2016