Exercise in Sjogren and Myositis

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 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: February 25, 2014
Last verified: February 2014
  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:


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 2014 (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
"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.

  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
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

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: February 25, 2014
Health Authority: Brazil: National Committee of Ethics in Research

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

ClinicalTrials.gov processed this record on September 16, 2014