High Intensity Interval Training and Rheumatoid Arthritis
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HIIT
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring High Intensity Interval Training
Eligibility Criteria
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.
Sites / Locations
- Duke Molecular Physiology Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
HIIT - RA
Arm Description
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
Outcomes
Primary Outcome Measures
Change in Disease Activity Scores
Secondary Outcome Measures
Change in Peak Oxygen Consumption
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02528344
Brief Title
High Intensity Interval Training and Rheumatoid Arthritis
Official Title
The Effects of High-Intensity Interval Training on Inflammation in Adults With Rheumatoid Arthritis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
High Intensity Interval Training
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HIIT - RA
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
HIIT
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in Disease Activity Scores
Time Frame
Baseline and Post-Intervention (12-weeks)
Secondary Outcome Measure Information:
Title
Change in Peak Oxygen Consumption
Time Frame
Baseline and Post-Intervention (12-weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Duke Molecular Physiology Institute
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
35523821
Citation
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.
Results Reference
derived
PubMed Identifier
34246305
Citation
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.
Results Reference
derived
PubMed Identifier
30587230
Citation
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.
Results Reference
derived
PubMed Identifier
29898765
Citation
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.
Results Reference
derived
Learn more about this trial
High Intensity Interval Training and Rheumatoid Arthritis
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