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Exercise in Sjogren, Myositis and Takayasu's Arteritis

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. Read our disclaimer for details. Identifier: NCT01501019
Recruitment Status : Unknown
Verified February 2016 by Bruno Gualano, University of Sao Paulo.
Recruitment status was:  Recruiting
First Posted : December 29, 2011
Last Update Posted : February 19, 2016
Information provided by (Responsible Party):
Bruno Gualano, University of Sao Paulo

Brief Summary:

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 or disease Intervention/treatment Phase
Primary Sjogren´s Syndrome Myositis Other: Exercise training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
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
Study Start Date : October 2011
Estimated Primary Completion Date : July 2016

Arm Intervention/treatment
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.

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

  2. Muscle strength [ Time Frame: Twelve weeks ]
  3. Quality of life [ Time Frame: Twelve weeks ]

Secondary Outcome Measures :
  1. Serum anti-inflammatory cytokines [ Time Frame: Twelve weeks ]

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

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

Information from the National Library of Medicine

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

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

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 identifier (NCT number): NCT01501019

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University of Sao Paulo School of Medicine Clinical Hospital Recruiting
Sao Paulo, Brazil, 05403-010
Contact: Thalita Blasques Dassouki, MSc    55 11 2661-8022   
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

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Bruno Gualano, Principal Investigator, University of Sao Paulo Identifier: NCT01501019     History of Changes
Other Study ID Numbers: Exercise in Autoimmunity
First Posted: December 29, 2011    Key Record Dates
Last Update Posted: February 19, 2016
Last Verified: February 2016
Additional relevant MeSH terms:
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Sjogren's Syndrome
Takayasu Arteritis
Aortic Arch Syndromes
Pathologic Processes
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Dry Eye Syndromes
Lacrimal Apparatus Diseases
Eye Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Vascular Diseases
Cardiovascular Diseases
Muscular Diseases
Neuromuscular Diseases
Nervous System Diseases
Aortic Diseases