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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03186924
Recruitment Status : Recruiting
First Posted : June 14, 2017
Last Update Posted : June 14, 2017
Sponsor:
Information provided by (Responsible Party):
Bruno Gualano, University of Sao Paulo

Brief Summary:
This research program aims to comprehensively investigate the clinical, physiological, metabolic, and molecular effects of reducing sedentary behavior in rheumatoid arthritis. This 4-month parallel-group randomized controlled trial aims 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. A multitude of gold-standard techniques will be applied to evaluate the effects of the intervention on several outcomes, including sedentary time (primary outcome), physical activity levels, clinical parameters specific to each condition, cardiometabolic risk factors, immune function, and health-related quality of life. In addition, skeletal muscle and blood samples will be collected and a variety of molecular analyses will be performed to gather knowledge on the potential mechanisms which underpin the response to this intervention.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Behavioral: Take a STAND for health Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Reducing Sedentary Time in Rheumatoid Arthritis: The Take a STAND for Health Study
Actual Study Start Date : June 8, 2017
Estimated Primary Completion Date : June 8, 2020
Estimated Study Completion Date : June 8, 2020

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. Sedentary behaviour as assessed by ActivPAL™ [ Time Frame: 4 months ]

Secondary Outcome Measures :
  1. Physical activity levels as assessed by ActiGraph GT3X® [ Time Frame: 4 months ]
  2. Disease activity as assessed by DAS28 [ Time Frame: 4 months ]
  3. Drug doses [ Time Frame: 4 months ]
    Current and cumulative dose of prednisone, and current use of biological agents and non-biological disease-modifying anti-rheumatic drugs

  4. Fatigue as assessed by the Fatigue Severity Scale [ Time Frame: 4 months ]
  5. Pain as assessed by the Visual Analogic Scale [ Time Frame: 4 months ]
  6. Body composition as assessed by densitometry (DEXA) [ Time Frame: 4 months ]
    lean mass, fat mass and bone mass

  7. Aerobic conditioning as assessed by a cardiopulmonary test [ Time Frame: 4 months ]
  8. Physical functioning as assessed by a Health Assessment Questionnaire [ Time Frame: 4 months ]
  9. Muscle function as assessed by a battery of tests [ Time Frame: 4 months ]
    Timed Stands Test and Timed Up-and-Go Test

  10. Arterial blood pressure [ Time Frame: 4 months ]
  11. Insulin sensitivity as assessed by surrogates of insulin sensitivity [ Time Frame: 4 months ]
  12. Inflammatory cytokines [ Time Frame: 4 months ]
  13. Lipid profile [ Time Frame: 4 months ]
    Total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides

  14. Heart rate responses to exercise as assessed by a cardiopulmonary test [ Time Frame: 4 months ]
    Chronotropic response and heart rate recovery

  15. Muscle sympathetic nerve activity as assessed by microneurography [ Time Frame: 4 months ]
  16. Quality of life as assessed by the SF-36 questionnaire [ Time Frame: 4 months ]
  17. Western blotting [ Time Frame: 4 months ]
  18. RT-PCR [ Time Frame: 4 months ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03186924


Locations
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Brazil
University of Sao Paulo Recruiting
Sao Paulo, Brazil, 05508-30
Contact: Bruno Gualano, PhD    551126618022    gualano@usp.br   
Principal Investigator: Bruno Gualano, PhD         
Sponsors and Collaborators
University of Sao Paulo

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bruno Gualano, Professor, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT03186924    
Other Study ID Numbers: Take a STAND for health RA
First Posted: June 14, 2017    Key Record Dates
Last Update Posted: June 14, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases