Primary Sjogren´s SyndromeNCT01501019
Exercise in Sjogren, Myositis and Takayasu's Arteritis
A study testing Exercise training in people with Primary Sjogren´s Syndrome and Myositis, run by University of Sao Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Primary Sjogren´s Syndrome, Myositis
- What is being tested?
- Exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2011to Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Physically inactive
- Stable drugs regime for at least three months
Who cannot join
- Other rheumatic diseases
- Physical disability that prevent the patient to perform the physical tests
- Severe pulmonary disease
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
University of Sao Paulo School of Medicine Clinical Hospital
São Paulo, São Paulo, 05403-010
Thalita Blasques Dassouki, MSc, 55 11 2661-8022, thatausp@yahoo.com.br
Ana Lucia Sa Pinto, PhD
About this study
Official title: 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.
- Conditions
- Primary Sjogren´s Syndrome, Myositis
- Being tested
- Exercise training
- Medical subject headings
- Myositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise trainingOther
"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.
| Study group | Role | What they receive |
|---|---|---|
| Sjogren and Myositis Control (no control for takayasu's) | No intervention | Not described |
| Sjogren, Myositis and Takayasu's Trained | Experimental | Not described Receives: Other: Exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aerobic Capacity
Maximum Oxygen Consumption (VO2Max)
Measured: Twelve weeks
Muscle strength
Measured: Twelve weeks
Quality of life
Measured: Twelve weeks
Secondary outcomes (3)
Serum anti-inflammatory cytokines
Interleukin-10
Measured: Twelve weeks
Serum pro-inflammatory cytokines
Interleukin-1 (IL-1), interleukin-6 (IL-6), tumor necrosis factor-a (TNF-a)
Measured: Twelve weeks
Serum inflammatory markers
erythrocyte sedimentation rate (ESR), c-reactive protein (CRP), aldolase
Measured: Twelve weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2011 (estimated)
- Study startOct 2011
- Primary completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary Sjogren´s SyndromeStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bruno Gualano, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01501019
- Sponsor's protocol ID
- Exercise in Autoimmunity
- Status last verified
- Feb 2016
- First submitted
- 29 Nov 2011
- Last updated
- 19 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25344395
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Exercise Training in Primary Sjogren´s Syndrome, Myositis and Takayasu's Arteritis
- ClinicalTrials.gov ID
- NCT01501019
- Acronym / sponsor ID
- Exercise in Autoimmunity
- Conditions
- Primary Sjogren´s Syndrome, Myositis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Jul 2016 (estimated)
- First posted
- 29 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sjogren and Myositis Control (no control for takayasu's) | No intervention | – |
| Sjogren, Myositis and Takayasu's Trained | Experimental | Other: Exercise training |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Physically inactive
- Stable drugs regime for at least three months
Key exclusion criteria (3 listed)
- Other rheumatic diseases
- Physical disability that prevent the patient to perform the physical tests
- Severe pulmonary disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Sjogren, Myositis and Takayasu's Trained |
Primary outcome
Aerobic Capacity
Time frame: Twelve weeks
Maximum Oxygen Consumption (VO2Max)
Muscle strength
Time frame: Twelve weeks
Quality of life
Time frame: Twelve weeks
3 secondary outcomes
Serum anti-inflammatory cytokines
Time frame: Twelve weeks
Serum pro-inflammatory cytokines
Time frame: Twelve weeks
Serum inflammatory markers
Time frame: Twelve weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2016.
- Derived from this study: PubMed 25344395Mattar 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
University of Sao Paulo School of Medicine Clinical Hospital
São Paulo, Brazil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise training in people with Primary Sjogren´s Syndrome and Myositis, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aerobic Capacity (time frame: Twelve weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01501019, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2016.