- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02528344
High Intensity Interval Training and Rheumatoid Arthritis
December 7, 2016 updated by: Duke University
The Effects of High-Intensity Interval Training on Inflammation in Adults With Rheumatoid Arthritis
The overall objective is to determine whether High Intensity Interval Training (HIIT) has potential to improve disease activity scores for Rheumatoid Arthritis (RA) patients.
By reducing inflammation and modifying immune function HIIT may offer a substantial paradigm shift in RA care, especially in older persons with RA who experience aging related-immunesenescence, increased systemic inflammation and greater physical inactivity than young persons.
Prior to embarking on a large scale trial of HIIT-induced disease modification, this pilot study aims to demonstrate that HIIT can produce measurable responses in disease activity scores and peak VO2in persons undergoing routine pharmacologic treatment for RA.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
12
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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North Carolina
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Durham, North Carolina, United States, 27710
- Duke Molecular Physiology Institute
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Seropositive (positive rheumatoid factor or anti-citrullinated protein antibody) or erosions typical of RA on radiographs.
- History of fulfilling 2010 ACR/EULAR Classification Criteria for RA
- Able to walk on a treadmill
- Not participating in regular physical exercise (more than 60 minutes of moderate intensity or 30 minutes of vigorous intensity exercise per week) or weight reduction dieting.
- No medication changes within the last three months.
- Willing to forego knee joint injections, regular NSAID use, and use acetaminophen for any necessary analgesia during the course of the intervention.
- No current (within the last three weeks) pharmacologic therapy with corticosteroids.
Exclusion Criteria:
- Coronary artery disease
- Diabetes mellitus
- Chronic obstructive pulmonary disease
- Absolute contra-indications to exercise: Recent (<6 months) acute cardiac event unstable angina, uncontrolled dysrhythmias causing symptoms or hemodynamic compromise, symptomatic aortic stenosis, uncontrolled symptomatic heart failure, acute pulmonary embolus, acute myocarditis or pericarditis, suspected or known dissecting aneurism and acute systemic infection.
- Other inflammatory arthropathy or myopathy, Paget's disease, pigmented villonodular synovitis, joint infection, ochronosis, neuropathic arthropathy, osteochondromatosis, acromegaly, hemochromatosis, Wilson's disease, osteonecrosis, knee replacement.
- Contraindicated Medicine: ticlopidine, clopidogrel, dipyridamole, warfarin, heparin, enoxaparin and other blood thinners.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: HIIT - RA
All participants will undergo high intensity interval training 3x/week for 10-12 weeks.
Intense exercise will be interspersed with appropriate rest periods of low intensity exercise
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All participants will undergo high intensity interval training 3x/week for 10-12 weeks.
Intense exercise will be interspersed with appropriate rest periods of low intensity exercise
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in Disease Activity Scores
Time Frame: Baseline and Post-Intervention (12-weeks)
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Baseline and Post-Intervention (12-weeks)
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in Peak Oxygen Consumption
Time Frame: Baseline and Post-Intervention (12-weeks)
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Baseline and Post-Intervention (12-weeks)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Andonian BJ, Koss A, Koves TR, Hauser ER, Hubal MJ, Pober DM, Lord JM, MacIver NJ, St Clair EW, Muoio DM, Kraus WE, Bartlett DB, Huffman KM. Rheumatoid arthritis T cell and muscle oxidative metabolism associate with exercise-induced changes in cardiorespiratory fitness. Sci Rep. 2022 May 6;12(1):7450. doi: 10.1038/s41598-022-11458-4.
- Andonian BJ, Johannemann A, Hubal MJ, Pober DM, Koss A, Kraus WE, Bartlett DB, Huffman KM. Altered skeletal muscle metabolic pathways, age, systemic inflammation, and low cardiorespiratory fitness associate with improvements in disease activity following high-intensity interval training in persons with rheumatoid arthritis. Arthritis Res Ther. 2021 Jul 10;23(1):187. doi: 10.1186/s13075-021-02570-3.
- Andonian BJ, Bartlett DB, Huebner JL, Willis L, Hoselton A, Kraus VB, Kraus WE, Huffman KM. Effect of high-intensity interval training on muscle remodeling in rheumatoid arthritis compared to prediabetes. Arthritis Res Ther. 2018 Dec 27;20(1):283. doi: 10.1186/s13075-018-1786-6.
- Bartlett DB, Willis LH, Slentz CA, Hoselton A, Kelly L, Huebner JL, Kraus VB, Moss J, Muehlbauer MJ, Spielmann G, Kraus WE, Lord JM, Huffman KM. Ten weeks of high-intensity interval walk training is associated with reduced disease activity and improved innate immune function in older adults with rheumatoid arthritis: a pilot study. Arthritis Res Ther. 2018 Jun 14;20(1):127. doi: 10.1186/s13075-018-1624-x.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2015
Primary Completion (Actual)
October 1, 2016
Study Registration Dates
First Submitted
August 17, 2015
First Submitted That Met QC Criteria
August 17, 2015
First Posted (Estimate)
August 19, 2015
Study Record Updates
Last Update Posted (Estimate)
December 8, 2016
Last Update Submitted That Met QC Criteria
December 7, 2016
Last Verified
June 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00064057
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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