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

NCT03186924 | Unknown

• 1 other identifier: Take a STAND for health RA
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• Sedentary behaviour as assessed by ActivPAL™

  4 months

Secondary Outcomes (21)

• Physical activity levels as assessed by ActiGraph GT3X®

  4 months

• Disease activity as assessed by DAS28

  4 months

• Drug doses

  4 months

• Fatigue as assessed by the Fatigue Severity Scale

  4 months

• Pain as assessed by the Visual Analogic Scale

  4 months (RCT) and 8 hours (crossover)

Study Arms (2)

Take a STAND for health

EXPERIMENTAL

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

Behavioral: Take a STAND for health

Control

NO INTERVENTION

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.

Interventions

Take a STAND for health BEHAVIORAL

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

Take a STAND for health

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Post-menopausal women diagnosed with rheumatoid arthritis

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

University of Sao Paulo

São Paulo, 05508-30, Brazil

RECRUITING

Related Publications (2)

• 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.

  PMID: 39283176 DERIVED

• 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.

  PMID: 32051025 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Health

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Population Characteristics

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: Professor

Model Details: 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.

Study Record Dates

• First Submitted: June 8, 2017
• First Posted: June 14, 2017
• Study Start: June 8, 2017
• Primary Completion: December 17, 2021
• Study Completion: December 17, 2021
• Last Updated: April 13, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)