Exercise in Sjogren, Myositis and Takayasu's Arteritis

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2016 by University of Sao Paulo
Information provided by (Responsible Party):
Bruno Gualano, University of Sao Paulo
ClinicalTrials.gov Identifier:
First received: November 29, 2011
Last updated: February 17, 2016
Last verified: February 2016

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
Other: Exercise training

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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 University of Sao Paulo:

Primary Outcome Measures:
  • Aerobic Capacity [ Time Frame: Twelve weeks ] [ Designated as safety issue: No ]
    Maximum Oxygen Consumption (VO2Max)

  • Muscle strength [ Time Frame: Twelve weeks ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: Twelve weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Serum anti-inflammatory cytokines [ Time Frame: Twelve weeks ] [ Designated as safety issue: Yes ]

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

  • Serum inflammatory markers [ Time Frame: Twelve weeks ] [ Designated as safety issue: Yes ]
    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.


Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
  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: NCT01501019

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 
Study First Received: November 29, 2011
Last Updated: February 17, 2016
Health Authority: Brazil: National Committee of Ethics in Research

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

ClinicalTrials.gov processed this record on May 26, 2016