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

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.

Study Overview

• Status: Recruiting
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Behavioral: Take a STAND for health

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo, Brazil, 05508-30
    • Recruiting
    • University of Sao Paulo
    • Contact: Bruno Gualano, PhD; Phone Number: 551126618022; Email: gualano@usp.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Take a STAND for health; A newly developed personalized intervention focused on replacing sedentary time with light-(or very light-) intensity physical activity	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
No Intervention: Control; 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?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University of Sao Paulo

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2017
• Primary Completion (Anticipated): December 17, 2021
• Study Completion (Anticipated): December 17, 2021

Study Registration Dates

• First Submitted: June 8, 2017
• First Submitted That Met QC Criteria: June 12, 2017
• First Posted (Actual): June 14, 2017

Study Record Updates

• Last Update Posted (Actual): April 13, 2021
• Last Update Submitted That Met QC Criteria: April 8, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: Take a STAND for health RA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No