Rheumatoid ArthritisNCT02528344
High Intensity Interval Training and Rheumatoid Arthritis
A study testing HIIT in people with Rheumatoid Arthritis, run by Duke University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- HIIT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke Molecular Physiology Institute
Durham, North Carolina, 27710
About this study
Official title: 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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- HIIT
- Keywords
- High Intensity Interval Training
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIITBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| HIIT - RA | Experimental | 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 Receives: Behavioral: HIIT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Disease Activity Scores
Measured: Baseline and Post-Intervention (12-weeks)
Secondary outcomes (1)
Change in Peak Oxygen Consumption
Measured: Baseline and Post-Intervention (12-weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2015 (estimated)
- Study startSep 2015
- Primary completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02528344
- Sponsor's protocol ID
- Pro00064057
- Status last verified
- Jun 2016
- First submitted
- 17 Aug 2015
- Last updated
- 8 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 35523821Andonian 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.
PubMed 34246305Andonian 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.
PubMed 30587230Bartlett 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.
PubMed 29898765
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of High-Intensity Interval Training on Inflammation in Adults With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT02528344
- Acronym / sponsor ID
- Pro00064057
- Conditions
- Rheumatoid Arthritis
- Keywords
- High Intensity Interval Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Oct 2016 (actual)
- First posted
- 19 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HIIT - RA | Experimental | Behavioral: HIITAll 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 |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HIITAll 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 | Behavioural | HIIT - RA |
Primary outcome
Change in Disease Activity Scores
Time frame: Baseline and Post-Intervention (12-weeks)
1 secondary outcome
Change in Peak Oxygen Consumption
Time frame: Baseline and Post-Intervention (12-weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2016.
- Derived from this study: PubMed 35523821Andonian 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.
- Derived from this study: PubMed 34246305Andonian 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.
- Derived from this study: PubMed 30587230Andonian 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.
- Derived from this study: PubMed 29898765Bartlett 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIIT in people with Rheumatoid Arthritis, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Disease Activity Scores (time frame: Baseline and Post-Intervention (12-weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02528344, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2016.