Exercise in Sjogren, Myositis and Takayasu's Arteritis
Effects of Exercise Training in Primary Sjogren´s Syndrome, Myositis and Takayasu's Arteritis
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2011
CompletedFirst Submitted
Initial submission to the registry
November 29, 2011
CompletedFirst Posted
Study publicly available on registry
December 29, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedFebruary 19, 2016
February 1, 2016
4.8 years
November 29, 2011
February 17, 2016
Conditions
Outcome Measures
Primary Outcomes (3)
Aerobic Capacity
Maximum Oxygen Consumption (VO2Max)
Twelve weeks
Muscle strength
Twelve weeks
Quality of life
Twelve weeks
Secondary Outcomes (3)
Serum anti-inflammatory cytokines
Twelve weeks
Serum pro-inflammatory cytokines
Twelve weeks
Serum inflammatory markers
Twelve weeks
Study Arms (2)
Sjogren and Myositis Control (no control for takayasu's)
NO INTERVENTIONSjogren, Myositis and Takayasu's Trained
EXPERIMENTALInterventions
"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.
Eligibility Criteria
You may qualify if:
- Physically inactive
- Stable drugs regime for at least three months
You may not qualify if:
- Other rheumatic diseases
- Physical disability that prevent the patient to perform the physical tests
- Severe pulmonary disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Sao Paulo School of Medicine Clinical Hospital
São Paulo, São Paulo, 05403-010, Brazil
Related Publications (1)
Mattar MA, Gualano B, Perandini LA, Shinjo SK, Lima FR, Sa-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.
PMID: 25344395DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 29, 2011
First Posted
December 29, 2011
Study Start
October 1, 2011
Primary Completion
July 1, 2016
Last Updated
February 19, 2016
Record last verified: 2016-02