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Exercise in Sjogren and Myositis

This study is currently recruiting participants.
Verified January 2013 by University of Sao Paulo
Sponsor:
Information provided by (Responsible Party):
Bruno Gualano, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01501019
First received: November 29, 2011
Last updated: January 17, 2013
Last verified: January 2013
History of Changes
  Purpose

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

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


Condition Intervention
Primary Sjogren´s Syndrome
Myositis
 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 and Myositis

Resource links provided by NLM:

U.S. FDA Resources

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 ]
    Interleukin-10

  • 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: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Sjogren and Myositis Control
Experimental: Sjogren and Myositis Trained Other: Exercise training
30-60 minutes of combined aerobic and strength exercises, twice a week, moderate intensity

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Bruno Gualano, Principal Investigator, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01501019     History of Changes
Other Study ID Numbers: Exercise, Sjogren and Myositis
Study First Received: November 29, 2011
Last Updated: January 17, 2013
Health Authority: Brazil: National Committee of Ethics in Research

Additional relevant MeSH terms:
Salivary Gland Diseases
Myositis
Sjogren's Syndrome
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Arthritis, Rheumatoid
Arthritis
Joint Diseases
 Rheumatic Diseases
Xerostomia
Mouth Diseases
Stomatognathic Diseases
Dry Eye Syndromes
Lacrimal Apparatus Diseases
Eye Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 19, 2013