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

Not Applicable

• Conditions: Rheumatoid Arthritis
• Interventions: Behavioral: Take a STAND for health

• Registration Number: NCT03186924
• Lead Sponsor: University of Sao Paulo

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-06-08
• Study First Submitted: 2017-06-08
• Study First Submitted QC: 2017-06-12
• Study First Posted: 2017-06-14
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-08
• Last Update Posted: 2021-04-13
• Primary Completion: 2021-12-17
• Study Completion: 2021-12-17

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

• Post-menopausal women diagnosed with rheumatoid arthritis

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Take a STAND for health	Take a STAND for health	A newly developed personalized intervention focused on replacing sedentary time with light-(or very light-) intensity physical activity

Primary Outcome Measures

Name	Time	Method
Sedentary behaviour as assessed by ActivPAL™	4 months

Secondary Outcome Measures

Name	Time	Method
Disease activity as assessed by DAS28	4 months
Drug doses	4 months	Current and cumulative dose of prednisone, and current use of biological agents and non-biological disease-modifying anti-rheumatic drugs
Pain as assessed by the Visual Analogic Scale	4 months (RCT) and 8 hours (crossover)
Blood pressure	4 months (RCT) and 8 hours (crossover)
Inflammatory cytokines	4 months (RCT) and 8 hours (crossover)
Aerobic conditioning as assessed by a cardiopulmonary test	4 months
Muscle function as assessed by a battery of tests	4 months	Timed Stands Test and Timed Up-and-Go Test
Insulin sensitivity as assessed by surrogates of insulin sensitivity	4 months (RCT) and 8 hours (crossover)	Glucose, insulin, c-peptide, and HbA1c
RT-PCR	4 months (RCT) and 8 hours (crossover)
Physical activity levels as assessed by ActiGraph GT3X®	4 months
Fatigue as assessed by the Fatigue Severity Scale	4 months
Heart rate responses to exercise as assessed by a cardiopulmonary test	4 months	Chronotropic response and heart rate recovery
Muscle sympathetic nerve activity as assessed by microneurography	4 months
Vascular function and structure as assessed using a high-resolution ultrasound machine	4 months	Flow-mediated dilation and carotid intima-media thickness
Quality of life as assessed by the SF-36 questionnaire	4 months
Western blotting	4 months (RCT) and 8 hours (crossover)
RNA sequencing	4 months (RCT) and 8 hours (crossover)
Body composition as assessed by densitometry (DEXA)	4 months	lean mass, fat mass and bone mass
Physical functioning as assessed by a Health Assessment Questionnaire	4 months
Lipid profile	4 months (RCT) and 8 hours (crossover)	Total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides
Lipidomics	4 months (RCT) and 8 hours (crossover)

Trial Locations

Locations (1)

University of Sao Paulo; 🇧🇷 Sao Paulo, Brazil