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

Study Overview
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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.

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

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Behavioral: Take a STAND for health


Participation Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Take a STAND for health<br>A newly developed personalized intervention focused on replacing sedentary time with light-(or very light-) intensity physical activity | Behavioral: Take a STAND for health<br>* The Take a STAND for health is a newly developed 4-month goal-setting intervention aimed at reducing sedentary behavior<br>|
| No Intervention: Control<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sedentary behaviour as assessed by ActivPAL™ |  | 4 months | 

Secondary Outcome Measures

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