Reducing Sedentary Time in Rheumatoid Arthritis: The Take a STAND for Health Study
Primary Purpose
Rheumatoid Arthritis
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Take a STAND for health
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
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
Sites / Locations
- University of Sao PauloRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Take a STAND for health
Control
Arm Description
A newly developed personalized intervention focused on replacing sedentary time with light-(or very light-) intensity physical activity
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.
Outcomes
Primary Outcome Measures
Sedentary behaviour as assessed by ActivPAL™
Secondary Outcome Measures
Physical activity levels as assessed by ActiGraph GT3X®
Disease activity as assessed by DAS28
Drug doses
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
Pain as assessed by the Visual Analogic Scale
Body composition as assessed by densitometry (DEXA)
lean mass, fat mass and bone mass
Aerobic conditioning as assessed by a cardiopulmonary test
Physical functioning as assessed by a Health Assessment Questionnaire
Muscle function as assessed by a battery of tests
Timed Stands Test and Timed Up-and-Go Test
Blood pressure
Insulin sensitivity as assessed by surrogates of insulin sensitivity
Glucose, insulin, c-peptide, and HbA1c
Inflammatory cytokines
Lipid profile
Total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides
Heart rate responses to exercise as assessed by a cardiopulmonary test
Chronotropic response and heart rate recovery
Muscle sympathetic nerve activity as assessed by microneurography
Quality of life as assessed by the SF-36 questionnaire
Western blotting
RT-PCR
RNA sequencing
Lipidomics
Vascular function and structure as assessed using a high-resolution ultrasound machine
Flow-mediated dilation and carotid intima-media thickness
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03186924
Brief Title
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
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 8, 2017 (Actual)
Primary Completion Date
December 17, 2021 (Anticipated)
Study Completion Date
December 17, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Take a STAND for health
Arm Type
Experimental
Arm Description
A newly developed personalized intervention focused on replacing sedentary time with light-(or very light-) intensity physical activity
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Take a STAND for health
Intervention Description
The Take a STAND for health is a newly developed 4-month goal-setting intervention aimed at reducing sedentary behavior
Primary Outcome Measure Information:
Title
Sedentary behaviour as assessed by ActivPAL™
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Physical activity levels as assessed by ActiGraph GT3X®
Time Frame
4 months
Title
Disease activity as assessed by DAS28
Time Frame
4 months
Title
Drug doses
Description
Current and cumulative dose of prednisone, and current use of biological agents and non-biological disease-modifying anti-rheumatic drugs
Time Frame
4 months
Title
Fatigue as assessed by the Fatigue Severity Scale
Time Frame
4 months
Title
Pain as assessed by the Visual Analogic Scale
Time Frame
4 months (RCT) and 8 hours (crossover)
Title
Body composition as assessed by densitometry (DEXA)
Description
lean mass, fat mass and bone mass
Time Frame
4 months
Title
Aerobic conditioning as assessed by a cardiopulmonary test
Time Frame
4 months
Title
Physical functioning as assessed by a Health Assessment Questionnaire
Time Frame
4 months
Title
Muscle function as assessed by a battery of tests
Description
Timed Stands Test and Timed Up-and-Go Test
Time Frame
4 months
Title
Blood pressure
Time Frame
4 months (RCT) and 8 hours (crossover)
Title
Insulin sensitivity as assessed by surrogates of insulin sensitivity
Description
Glucose, insulin, c-peptide, and HbA1c
Time Frame
4 months (RCT) and 8 hours (crossover)
Title
Inflammatory cytokines
Time Frame
4 months (RCT) and 8 hours (crossover)
Title
Lipid profile
Description
Total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides
Time Frame
4 months (RCT) and 8 hours (crossover)
Title
Heart rate responses to exercise as assessed by a cardiopulmonary test
Description
Chronotropic response and heart rate recovery
Time Frame
4 months
Title
Muscle sympathetic nerve activity as assessed by microneurography
Time Frame
4 months
Title
Quality of life as assessed by the SF-36 questionnaire
Time Frame
4 months
Title
Western blotting
Time Frame
4 months (RCT) and 8 hours (crossover)
Title
RT-PCR
Time Frame
4 months (RCT) and 8 hours (crossover)
Title
RNA sequencing
Time Frame
4 months (RCT) and 8 hours (crossover)
Title
Lipidomics
Time Frame
4 months (RCT) and 8 hours (crossover)
Title
Vascular function and structure as assessed using a high-resolution ultrasound machine
Description
Flow-mediated dilation and carotid intima-media thickness
Time Frame
4 months
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
University of Sao Paulo
City
Sao Paulo
ZIP/Postal Code
05508-30
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bruno Gualano, PhD
Phone
551126618022
Email
gualano@usp.br
First Name & Middle Initial & Last Name & Degree
Bruno Gualano, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32051025
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.
Results Reference
derived
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Reducing Sedentary Time in Rheumatoid Arthritis: The Take a STAND for Health Study
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