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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03186924
• Other study ID #: Take a STAND for health RA
• Status: Recruiting
• Phase: N/A
• Start date: June 8, 2017
• Est. completion date: December 17, 2021

Study information

• Verified date: April 2021
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 17, 2021
• Est. primary completion date: December 17, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

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

Locations

Country	Name	City	State
Brazil	University of Sao Paulo	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

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