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Rheumatoid ArthritisNCT03186924

Reducing Sedentary Time in Rheumatoid Arthritis: The Take a STAND for Health Study

A study testing Take a STAND for health in people with Rheumatoid Arthritis, run by University of Sao Paulo at 1 site in Brazil.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This research program aims to comprehensively investigate the clinical, physiological, metabolic, and molecular effects of reducing sedentary behavior in rheumatoid arthritis. To this aim, we will conduct a 4-month parallel-group randomized controlled trial aiming to investigate the feasibility and efficacy of a newly… Read more about this study

Who is it for?
Any age, women only
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
Take a STAND for health
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteBrazil
Study dates
8 Jun 2017to 17 Dec 2021
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 Any age
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Post-menopausal women diagnosed with rheumatoid arthritis

Who cannot join

  • any physical disabilities that preclude physical exercise testing
  • participation in structured exercise training programs within the last 12 months
  • unstable dose of disease modifying drugs, including biological therapy, in the last 3 months prior to and during the study

Trial locations and contacts

1 site in 1 country.

Brazil1 site, 1 recruiting

  • University of Sao Paulo

    São Paulo, 05508-30

    Bruno Gualano, PhD, 551126618022, gualano@usp.br

    Bruno Gualano, PhD

    Recruiting

Other trials in Brazil

About this study

This research program aims to comprehensively investigate the clinical, physiological, metabolic, and molecular effects of reducing sedentary behavior in rheumatoid arthritis. To this aim, we will conduct a 4-month parallel-group randomized controlled trial aiming to investigate the feasibility and efficacy of a newly developed personalized intervention focused on replacing sedentary time with light-(or very light-) intensity physical activity in rheumatoid arthritis. Additionally, a sub-sample of patients will complete a randomised cross-over study aiming to unravel potential mechanisms underlying the metabolic, physiological and molecular effects of breaking up sedentary time with light-intensity physical activity versus carrying out the minimum amount of daily exercise at once and then remaining sedentary versus simply remaining sedentary throughout all sessions, in a well-controlled laboratorial condition.

Being tested
Take a STAND for health
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Take a STAND for healthBehavioural

    The Take a STAND for health is a newly developed 4-month goal-setting intervention aimed at reducing sedentary behavior

Study groups in NCT03186924
Study groupRoleWhat they receive
Take a STAND for healthExperimentalA newly developed personalized intervention focused on replacing sedentary time with light-(or very light-) intensity physical activity
Receives: Behavioral: Take a STAND for health
ControlNo interventionThe control group will receive all regular medical care and advice on healthy lifestyle, including the promotion of recommended physical activity levels and health nutrition.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sedentary behaviour as assessed by ActivPAL™

    Measured: 4 months

Secondary outcomes (21)

  1. Physical activity levels as assessed by ActiGraph GT3X®

    Measured: 4 months

  2. Disease activity as assessed by DAS28

    Measured: 4 months

  3. Drug doses

    Current and cumulative dose of prednisone, and current use of biological agents and non-biological disease-modifying anti-rheumatic drugs

    Measured: 4 months

  4. Fatigue as assessed by the Fatigue Severity Scale

    Measured: 4 months

  5. Pain as assessed by the Visual Analogic Scale

    Measured: 4 months (RCT) and 8 hours (crossover)

  6. Body composition as assessed by densitometry (DEXA)

    lean mass, fat mass and bone mass

    Measured: 4 months

  7. Aerobic conditioning as assessed by a cardiopulmonary test

    Measured: 4 months

  8. Physical functioning as assessed by a Health Assessment Questionnaire

    Measured: 4 months

  9. Muscle function as assessed by a battery of tests

    Timed Stands Test and Timed Up-and-Go Test

    Measured: 4 months

  10. Blood pressure

    Measured: 4 months (RCT) and 8 hours (crossover)

  11. Insulin sensitivity as assessed by surrogates of insulin sensitivity

    Glucose, insulin, c-peptide, and HbA1c

    Measured: 4 months (RCT) and 8 hours (crossover)

  12. Inflammatory cytokines

    Measured: 4 months (RCT) and 8 hours (crossover)

  13. Lipid profile

    Total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides

    Measured: 4 months (RCT) and 8 hours (crossover)

  14. Heart rate responses to exercise as assessed by a cardiopulmonary test

    Chronotropic response and heart rate recovery

    Measured: 4 months

  15. Muscle sympathetic nerve activity as assessed by microneurography

    Measured: 4 months

  16. Quality of life as assessed by the SF-36 questionnaire

    Measured: 4 months

  17. Western blotting

    Measured: 4 months (RCT) and 8 hours (crossover)

  18. RT-PCR

    Measured: 4 months (RCT) and 8 hours (crossover)

  19. RNA sequencing

    Measured: 4 months (RCT) and 8 hours (crossover)

  20. Lipidomics

    Measured: 4 months (RCT) and 8 hours (crossover)

  21. Vascular function and structure as assessed using a high-resolution ultrasound machine

    Flow-mediated dilation and carotid intima-media thickness

    Measured: 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jun 2017
  2. Study start8 Jun 2017
  3. Primary completion17 Dec 2021 (estimated)
  4. Study completion17 Dec 2021 (estimated)

Resources

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
Model description
We will perform a 4-month parallel-group randomised controlled trial, in which rheumatoid arthritis patients will be assessed at baseline (PRE) and after 4 months (POST). Moreover, a sub-sample (n=18) of patients will perform a randomised crossover trial at baseline (PRE). Patients will complete three experimental sessions in a random manner, as follows: Prolonged sitting (SIT), in which participants engaged in prolonged sitting throughout an 8-h period and were instructed to minimize excessive movement; Exercise followed by prolonged sitting (EX), in which participants performed a 30-min moderate-to-vigorous exercise bout on a treadmill, subsequently, participants engaged in prolonged sitting as described for SIT; Light-intensity breaks (BR), in which participants completed a 3-min bout of light-intensity walking every 30 min of sitting throughout the experimental period.
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03186924
Sponsor's protocol ID
Take a STAND for health RA
Status last verified
Apr 2021
First submitted
8 Jun 2017
Last updated
13 Apr 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Pinto AJ, Meireles K, Pecanha T, Mazzolani BC, Smaira FI, Rezende D, Benatti FB, DE Medeiros Ribeiro AC, DE Sa Pinto AL, Lima FR, Roschel H, Gualano B. Clinical and Cardiometabolic Effects of Reducing Sedentary Behavior in Postmenopausal Women with Rheumatoid Arthritis. Med Sci Sports Exerc. 2025 Jan 1;57(1):23-32. doi: 10.1249/MSS.0000000000003546. Epub 2024 Sep 16.

    PubMed 39283176

  • Pinto AJ, Pecanha T, Meireles K, Benatti FB, Bonfiglioli K, de Sa Pinto AL, Lima FR, Pereira RMR, Irigoyen MCC, Turner JE, Kirwan JP, Owen N, Dunstan DW, Roschel H, Gualano B. A randomized controlled trial to reduce sedentary time in rheumatoid arthritis: protocol and rationale of the Take a STAND for Health study. Trials. 2020 Feb 12;21(1):171. doi: 10.1186/s13063-020-4104-y.

    PubMed 32051025

Questions about this trial

What is this clinical trial studying?

A study testing Take a STAND for health in people with Rheumatoid Arthritis, 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 1 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 13 Apr 2021. 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?

Sedentary behaviour as assessed by ActivPAL™ (time frame: 4 months). 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 NCT03186924, which also lists 2 linked publications.

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 13 Apr 2021.

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