Clinical trial NCT03186924: Reducing Sedentary Time in Rheumatoid Arthritis: The Take a STAND for Health Study
Official title: Reducing Sedentary Time in Rheumatoid Arthritis: The Take a STAND for Health Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rheumatoid Arthritis
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2017-06-14
Enrollment: 30
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Sedentary behaviour as assessed by ActivPAL™
timeFrame: 4 months
Secondary outcomes:
measure: Physical activity levels as assessed by ActiGraph GT3X®
timeFrame: 4 months
measure: Disease activity as assessed by DAS28
timeFrame: 4 months
measure: Drug doses
timeFrame: 4 months
measure: Fatigue as assessed by the Fatigue Severity Scale
timeFrame: 4 months
measure: Pain as assessed by the Visual Analogic Scale
timeFrame: 4 months (RCT) and 8 hours (crossover)
measure: Body composition as assessed by densitometry (DEXA)
timeFrame: 4 months
measure: Aerobic conditioning as assessed by a cardiopulmonary test
timeFrame: 4 months
measure: Physical functioning as assessed by a Health Assessment Questionnaire
timeFrame: 4 months
measure: Muscle function as assessed by a battery of tests
timeFrame: 4 months
measure: Blood pressure
timeFrame: 4 months (RCT) and 8 hours (crossover)
measure: Insulin sensitivity as assessed by surrogates of insulin sensitivity
timeFrame: 4 months (RCT) and 8 hours (crossover)
measure: Inflammatory cytokines
timeFrame: 4 months (RCT) and 8 hours (crossover)
measure: Lipid profile
timeFrame: 4 months (RCT) and 8 hours (crossover)
measure: Heart rate responses to exercise as assessed by a cardiopulmonary test
timeFrame: 4 months
measure: Muscle sympathetic nerve activity as assessed by microneurography
timeFrame: 4 months
measure: Quality of life as assessed by the SF-36 questionnaire
timeFrame: 4 months
measure: Western blotting
timeFrame: 4 months (RCT) and 8 hours (crossover)
measure: RT-PCR
timeFrame: 4 months (RCT) and 8 hours (crossover)
measure: RNA sequencing
timeFrame: 4 months (RCT) and 8 hours (crossover)
measure: Lipidomics
timeFrame: 4 months (RCT) and 8 hours (crossover)
measure: Vascular function and structure as assessed using a high-resolution ultrasound machine
timeFrame: 4 months
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: University of Sao Paulo
Study officials:
References:
citation: 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.