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Exercise in Sjogren, Myositis and Takayasu's Arteritis

This study is currently recruiting participants.
Verified February 2016 by Bruno Gualano, University of Sao Paulo
Sponsor:
ClinicalTrials.gov Identifier:
NCT01501019
First Posted: December 29, 2011
Last Update Posted: February 19, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Bruno Gualano, University of Sao Paulo
  Purpose

Exercise may improve physical capacity and health parameters in Primary Syndrome´s Sjogren, Myositis and Takayasu's Arteritis.

Therefore, this study aims to investigate the role of an exercise training program in patients with Primary Syndrome´s Sjogren, Myositis and Takayasu's Arteritis.


Condition Intervention
Primary Sjogren´s Syndrome Myositis Other: Exercise training

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Exercise Training in Primary Sjogren´s Syndrome, Myositis and Takayasu's Arteritis

Resource links provided by NLM:


Further study details as provided by Bruno Gualano, University of Sao Paulo:

Primary Outcome Measures:
  • Aerobic Capacity [ Time Frame: Twelve weeks ]
    Maximum Oxygen Consumption (VO2Max)

  • Muscle strength [ Time Frame: Twelve weeks ]
  • Quality of life [ Time Frame: Twelve weeks ]

Secondary Outcome Measures:
  • Serum anti-inflammatory cytokines [ Time Frame: Twelve weeks ]
    Interleukin-10

  • Serum pro-inflammatory cytokines [ Time Frame: Twelve weeks ]
    Interleukin-1 (IL-1), interleukin-6 (IL-6), tumor necrosis factor-a (TNF-a)

  • Serum inflammatory markers [ Time Frame: Twelve weeks ]
    erythrocyte sedimentation rate (ESR), c-reactive protein (CRP), aldolase


Estimated Enrollment: 60
Study Start Date: October 2011
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Sjogren and Myositis Control (no control for takayasu's)
Experimental: Sjogren, Myositis and Takayasu's Trained Other: Exercise training

"Sjöegren arm": 30-60 minutes of combined aerobic and strength exercises, twice a week, moderate intensity.

"Myositis arm": 30 minutes of resistance training combined partial blood flow restriction, twice a week, low intensity.

"Takayasu's arteritis arm": 30-50 minutes of aerobic, twice a week, moderate intensity.


  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Physically inactive
  • Stable drugs regime for at least three months

Exclusion Criteria:

  • Other rheumatic diseases
  • Physical disability that prevent the patient to perform the physical tests
  • Severe pulmonary disease
  Contacts and Locations
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): NCT01501019


Locations
Brazil
University of Sao Paulo School of Medicine Clinical Hospital Recruiting
Sao Paulo, Brazil, 05403-010
Contact: Thalita Blasques Dassouki, MSc    55 11 2661-8022    thatausp@yahoo.com.br   
Principal Investigator: Ana Lucia Sa Pinto, PhD         
Sub-Investigator: Bruno Gualano, PhD         
Sub-Investigator: Fernanda R Lima, PhD         
Sub-Investigator: Hamilton Roschel, PhD         
Sub-Investigator: Sandra G Pasoto, PhD         
Sponsors and Collaborators
University of Sao Paulo
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bruno Gualano, Principal Investigator, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01501019     History of Changes
Other Study ID Numbers: Exercise in Autoimmunity
First Submitted: November 29, 2011
First Posted: December 29, 2011
Last Update Posted: February 19, 2016
Last Verified: February 2016

Additional relevant MeSH terms:
Salivary Gland Diseases
Syndrome
Sjogren's Syndrome
Arteritis
Myositis
Takayasu Arteritis
Aortic Arch Syndromes
Disease
Pathologic Processes
Arthritis, Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Xerostomia
Mouth Diseases
Stomatognathic Diseases
Dry Eye Syndromes
Lacrimal Apparatus Diseases
Eye Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Vasculitis
Vascular Diseases
Cardiovascular Diseases
Muscular Diseases
Neuromuscular Diseases
Nervous System Diseases
Aortic Diseases