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Exercise in Sjogren, Myositis and Takayasu's Arteritis

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ClinicalTrials.gov 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
Sponsor:
Information provided by (Responsible Party):
Bruno Gualano, University of Sao Paulo

November 29, 2011
December 29, 2011
February 19, 2016
October 2011
July 2016   (Final data collection date for primary outcome measure)
  • Aerobic Capacity [ Time Frame: Twelve weeks ]
    Maximum Oxygen Consumption (VO2Max)
  • Muscle strength [ Time Frame: Twelve weeks ]
  • Quality of life [ Time Frame: Twelve weeks ]
Aerobic Capacity [ Time Frame: Twelve weeks ]
Maximum Oxygen Consumption (VO2Max)
Complete list of historical versions of study NCT01501019 on ClinicalTrials.gov Archive Site
  • 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
  • Serum anti-inflammatory citokines [ Time Frame: Twelve weeks ]
    Interleukin-10
  • Serum pro-inflammatory citokines [ 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
Not Provided
Not Provided
 
Exercise in Sjogren, Myositis and Takayasu's Arteritis
Effects of Exercise Training in Primary Sjogren´s Syndrome, Myositis and Takayasu's Arteritis

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.

Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Primary Sjogren´s Syndrome
  • Myositis
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.

  • No Intervention: Sjogren and Myositis Control (no control for takayasu's)
  • Experimental: Sjogren, Myositis and Takayasu's Trained
    Intervention: Other: Exercise training
Mattar MA, Gualano B, Perandini LA, Shinjo SK, Lima FR, Sá-Pinto AL, Roschel H. Safety and possible effects of low-intensity resistance training associated with partial blood flow restriction in polymyositis and dermatomyositis. Arthritis Res Ther. 2014 Oct 25;16(5):473. doi: 10.1186/s13075-014-0473-5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
60
Same as current
Not Provided
July 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
 
NCT01501019
Exercise in Autoimmunity
No
Not Provided
Not Provided
Bruno Gualano, University of Sao Paulo
University of Sao Paulo
Not Provided
Not Provided
University of Sao Paulo
February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP