Exercise in Sjogren, Myositis and Takayasu's Arteritis

February 17, 2016 updated by: Bruno Gualano, University of Sao Paulo

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Sao Paulo, Brazil, 05403-010
        • Recruiting
        • University of Sao Paulo School of Medicine Clinical Hospital
        • Contact:
        • Sub-Investigator:
          • Fernanda R Lima, PhD
        • Sub-Investigator:
          • Hamilton Roschel, PhD
        • Sub-Investigator:
          • Sandra G Pasoto, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Aerobic Capacity
Time Frame: Twelve weeks
Maximum Oxygen Consumption (VO2Max)
Twelve weeks
Muscle strength
Time Frame: Twelve weeks
Twelve weeks
Quality of life
Time Frame: Twelve weeks
Twelve weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum anti-inflammatory cytokines
Time Frame: Twelve weeks
Interleukin-10
Twelve weeks
Serum pro-inflammatory cytokines
Time Frame: Twelve weeks
Interleukin-1 (IL-1), interleukin-6 (IL-6), tumor necrosis factor-a (TNF-a)
Twelve weeks
Serum inflammatory markers
Time Frame: Twelve weeks
erythrocyte sedimentation rate (ESR), c-reactive protein (CRP), aldolase
Twelve weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (ANTICIPATED)

July 1, 2016

Study Registration Dates

First Submitted

November 29, 2011

First Submitted That Met QC Criteria

December 26, 2011

First Posted (ESTIMATE)

December 29, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

February 19, 2016

Last Update Submitted That Met QC Criteria

February 17, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Exercise in Autoimmunity

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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