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Exercise in Sjogren, Myositis and Takayasu's Arteritis

Primary Purpose

Primary Sjogren´s Syndrome, Myositis

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Exercise training
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Sjogren´s Syndrome

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Sao Paulo School of Medicine Clinical HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Sjogren and Myositis Control (no control for takayasu's)

Sjogren, Myositis and Takayasu's Trained

Arm Description

Outcomes

Primary Outcome Measures

Aerobic Capacity
Maximum Oxygen Consumption (VO2Max)
Muscle strength
Quality of life

Secondary Outcome Measures

Serum anti-inflammatory cytokines
Interleukin-10
Serum pro-inflammatory cytokines
Interleukin-1 (IL-1), interleukin-6 (IL-6), tumor necrosis factor-a (TNF-a)
Serum inflammatory markers
erythrocyte sedimentation rate (ESR), c-reactive protein (CRP), aldolase

Full Information

First Posted
November 29, 2011
Last Updated
February 17, 2016
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT01501019
Brief Title
Exercise in Sjogren, Myositis and Takayasu's Arteritis
Official Title
Effects of Exercise Training in Primary Sjogren´s Syndrome, Myositis and Takayasu's Arteritis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Unknown status
Study Start Date
October 2011 (undefined)
Primary Completion Date
July 2016 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Sjogren´s Syndrome, Myositis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sjogren and Myositis Control (no control for takayasu's)
Arm Type
No Intervention
Arm Title
Sjogren, Myositis and Takayasu's Trained
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Exercise training
Intervention Description
"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.
Primary Outcome Measure Information:
Title
Aerobic Capacity
Description
Maximum Oxygen Consumption (VO2Max)
Time Frame
Twelve weeks
Title
Muscle strength
Time Frame
Twelve weeks
Title
Quality of life
Time Frame
Twelve weeks
Secondary Outcome Measure Information:
Title
Serum anti-inflammatory cytokines
Description
Interleukin-10
Time Frame
Twelve weeks
Title
Serum pro-inflammatory cytokines
Description
Interleukin-1 (IL-1), interleukin-6 (IL-6), tumor necrosis factor-a (TNF-a)
Time Frame
Twelve weeks
Title
Serum inflammatory markers
Description
erythrocyte sedimentation rate (ESR), c-reactive protein (CRP), aldolase
Time Frame
Twelve weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
University of Sao Paulo School of Medicine Clinical Hospital
City
Sao Paulo
ZIP/Postal Code
05403-010
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thalita Blasques Dassouki, MSc
Phone
55 11 2661-8022
Email
thatausp@yahoo.com.br
First Name & Middle Initial & Last Name & Degree
Ana Lucia Sa Pinto, PhD
First Name & Middle Initial & Last Name & Degree
Bruno Gualano, PhD
First Name & Middle Initial & Last Name & Degree
Fernanda R Lima, PhD
First Name & Middle Initial & Last Name & Degree
Hamilton Roschel, PhD
First Name & Middle Initial & Last Name & Degree
Sandra G Pasoto, PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
25344395
Citation
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.
Results Reference
derived

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Exercise in Sjogren, Myositis and Takayasu's Arteritis

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