Rheumatoid Arthritis
Conditions
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.
Interventions
BEHAVIORALTake a STAND for health
The Take a STAND for health is a newly developed 4-month goal-setting intervention aimed at reducing sedentary behavior
Sponsors
University of Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sedentary behaviour as assessed by ActivPAL™ | 4 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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) | 4 months | lean mass, fat mass and bone mass |
| 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 | 4 months | Timed Stands Test and Timed Up-and-Go Test |
| Blood pressure | 4 months (RCT) and 8 hours (crossover) | — |
| Insulin sensitivity as assessed by surrogates of insulin sensitivity | 4 months (RCT) and 8 hours (crossover) | Glucose, insulin, c-peptide, and HbA1c |
| Physical activity levels as assessed by ActiGraph GT3X® | 4 months | — |
| Lipid profile | 4 months (RCT) and 8 hours (crossover) | Total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides |
| 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 | — |
| 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 | 4 months | Flow-mediated dilation and carotid intima-media thickness |
| Inflammatory cytokines | 4 months (RCT) and 8 hours (crossover) | — |
Countries
Brazil
Outcome results
None listed