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

NCT ID: NCT03186924

Last Updated: 2021-04-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-08

Study Completion Date

2021-12-17

Brief Summary

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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.

Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Take a STAND for health

A newly developed personalized intervention focused on replacing sedentary time with light-(or very light-) intensity physical activity

Group Type EXPERIMENTAL

Take a STAND for health

Intervention Type BEHAVIORAL

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

Control

The control group will receive all regular medical care and advice on healthy lifestyle, including the promotion of recommended physical activity levels and health nutrition.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Take a STAND for health

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Post-menopausal women diagnosed with rheumatoid arthritis

Exclusion Criteria

* 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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Bruno Gualano

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Sao Paulo

São Paulo, , Brazil

Site Status RECRUITING

Countries

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Brazil

Facility Contacts

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Bruno Gualano, PhD

Role: primary

551126618022

References

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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.

Reference Type DERIVED
PMID: 39283176 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32051025 (View on PubMed)

Other Identifiers

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Take a STAND for health RA

Identifier Type: -

Identifier Source: org_study_id

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