NCT01501019

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

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 29, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 29, 2011

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Last Updated

February 19, 2016

Status Verified

February 1, 2016

Enrollment Period

4.8 years

First QC Date

November 29, 2011

Last Update Submit

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 INTERVENTION

Sjogren, Myositis and Takayasu's Trained

EXPERIMENTAL
Other: Exercise training

Interventions

"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.

Sjogren, Myositis and Takayasu's Trained

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

RECRUITING

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.

MeSH Terms

Conditions

Myositis

Interventions

Exercise

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

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

Locations