Rheumatoid ArthritisTRAINERaNCT06841562
Targeted Remotely-delivered Anti-inflammatory Interventions With Exercise for Rheumatoid Arthritis
A study testing TRAINERa intensive exercise training in people with Rheumatoid Arthritis, run by Duke University at 1 site in United States.
Trial summary
The primary objective of this study is to assess the feasibility of an intensive, remotely-delivered, combined aerobic and resistance training exercise program for patients with Rheumatoid Arthritis (RA) and to collect data to support power calculations for a larger research study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- TRAINERa intensive exercise training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jul 2025to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Persons with early RA - defined as duration of diagnosis equal to or less than 6 months, and not currently taking biologic DMARD therapy. Participants may be on one or a combination of the following conventional synthetic DMARDs: hydroxychloroquine, methotrexate, sulfasalazine, leflunomide, azathioprine
- 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
- Active RA, not in clinical disease remission (Clinical Disease Activity Index for RA (CDAI) > 2.8)
- Stable doses (for ≥ 1 month) of all RA and cardiovascular risk-related medications (including statins, metformin, SGLT2 inhibitors, GLP1RA) except for glucocorticoids
Who cannot join
- Pregnant or intending to become pregnant during the intervention period
- Current treatment with exogenous insulin
- Other inflammatory arthropathy or myopathy, Paget's disease, pigmented villonodular synovitis, joint infection, ochronosis, neuropathic arthropathy, osteochondromatosis, acromegaly, hemochromatosis, or Wilson's disease
- Current malignancy other than minimally invasive carcinomas routinely treated topically or with minor surgical treatment
- Absolute contraindications to exercise testing: ongoing unstable angina; uncontrolled cardiac arrhythmia with hemodynamic compromise; active endocarditis; symptomatic severe aortic stenosis; decompensated heart failure; acute pulmonary embolism, pulmonary infarction, or deep vein thrombosis; acute myocarditis or pericarditis; acute aortic dissection; physical disability that precludes safe and adequate testing
- Relative contraindications to exercise testing: known obstructive left main coronary artery stenosis; moderate to severe aortic stenosis with uncertain relation to symptoms; tachyarrhythmias with uncontrolled ventricular rates; acquired advanced or complete heart block; hypertrophic obstructive cardiomyopathy with severe resting gradient; recent stroke or transient ischemic attack; mental impairment with limited ability to cooperate; uncorrected medical conditions, such as hypertension (see below), significant anemia, important electrolyte imbalance, and hyperthyroidism
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- Acute myocardial infarction (MI) within six months
- Resting hypertension with systolic or diastolic blood pressures ≥180/110 mm Hg
- Lack of internet access
- Planned, intentional weight loss during study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Duke University
Durham, North Carolina, 27710
Alyssa Sudnick, MS, 19196606769, alyssa.sudnick@duke.edu
Brian J Andonian, MD, MHSc
About this study
Official title: Targeted Remotely-delivered Anti-inflammatory Interventions With Exercise for Rheumatoid Arthritis - Early Rheumatoid Arthritis Pilot Study
The primary objective of this study is to assess the feasibility of an intensive, remotely-delivered, combined aerobic and resistance training exercise program for patients with Rheumatoid Arthritis (RA) and to collect data to support power calculations for a larger research study.
Read the detailed description
The primary aim of this study is to assess the feasibility of an intensive, remotely-delivered, combined aerobic and resistance training exercise intervention program for patients with Rheumatoid Arthritis (RA) and to collect data to inform the design of a larger research study. This protocol will build upon a recent project, gathering additional data to support future grant applications. The findings will provide critical information for determining the design and appropriate sample size and ensuring sufficient statistical power for a larger study. Additionally, this pilot will evaluate the practicality of implementing a remotely supervised exercise training intervention in early and active RA patients, helping to establish its potential for broader clinical use.
- Conditions
- Rheumatoid Arthritis
- Being tested
- TRAINERa intensive exercise training
- Keywords
- exercise 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.
TRAINERa intensive exercise trainingBehavioural
Remotely-delivered exercise training intervention
| Study group | Role | What they receive |
|---|---|---|
| TRAINERa intensive exercise training | Experimental | Participants with early and active rheumatoid arthritis (RA) will complete a 12-week RA-tailored remotely supervised and delivered moderate to vigorous intensity aerobic training combined with resistance training exercise program. Receives: Behavioral: TRAINERa intensive exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of exercise training intervention
Feasibility will be measured as a dichotomous outcome through patient adherence, defined as meeting 100% of the prescribed exercise protocol, on average.
Measured: The primary feasibility target is participant adherence to the intervention protocol exercise prescription averaged over the course of the final 6 weeks of the 12-week program > 60%.
Secondary outcomes (2)
Acceptability of exercise training intervention
Acceptability will be measured with dichotomous patient-reported responses to questions on willingness to recommend the current intervention to others with RA and willingness to participate in such a study again.
Measured: 12 weeks
Safety of exercise training intervention
Safety will be measured by adverse events and serious adverse events.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2025
- Study start14 Jul 2025
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brian J Andonian, MD, MHSc, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06841562
- Sponsor's protocol ID
- PRO00117047
- Acronym
- TRAINERa
- Status last verified
- Mar 2026
- First submitted
- 19 Feb 2025
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: New clinical data will be collected from 15 participants with rheumatoid arthritis before and after a 12-week exercise training intervention. All de-identified individual participant data (including demographic, clinical and immune cell data) will be deposited into a NIH supported public repository. Adequate information will be retained to generate a unique identifier for each study participant.
Publications
Andonian BJ, Ross LM, Sudnick AM, Johnson JL, Pieper CF, Belski KB, Counts JD, King AP, Wallis JT, Bennett WC, Gillespie JC, Moertl KM, Richard D, Huebner JL, Connelly MA, Siegler IC, Kraus WE, Bales CW, Porter Starr KN, Huffman KM. Effect of Remotely Supervised Weight Loss and Exercise Training Versus Lifestyle Counseling on Cardiovascular Risk and Clinical Outcomes in Older Adults With Rheumatoid Arthritis: A Randomized Controlled Trial. ACR Open Rheumatol. 2024 Mar;6(3):124-136. doi: 10.1002/acr2.11639. Epub 2023 Dec 21.
PubMed 38126260
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeted Remotely-delivered Anti-inflammatory Interventions With Exercise for Rheumatoid Arthritis - Early Rheumatoid Arthritis Pilot Study
- ClinicalTrials.gov ID
- NCT06841562
- Acronym / sponsor ID
- TRAINERa / PRO00117047
- Conditions
- Rheumatoid Arthritis
- Keywords
- exercise training
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 14 Jul 2025 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 24 Feb 2025 (actual)
- 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 primary objective of this study is to assess the feasibility of an intensive, remotely-delivered, combined aerobic and resistance training exercise program for patients with Rheumatoid Arthritis (RA) and to collect data to support power calculations for a larger research study.
Detailed description
The primary aim of this study is to assess the feasibility of an intensive, remotely-delivered, combined aerobic and resistance training exercise intervention program for patients with Rheumatoid Arthritis (RA) and to collect data to inform the design of a larger research study. This protocol will build upon a recent project, gathering additional data to support future grant applications. The findings will provide critical information for determining the design and appropriate sample size and ensuring sufficient statistical power for a larger study. Additionally, this pilot will evaluate the practicality of implementing a remotely supervised exercise training intervention in early and active RA patients, helping to establish its potential for broader clinical use.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TRAINERa intensive exercise training | Experimental | Behavioral: TRAINERa intensive exercise trainingParticipants with early and active rheumatoid arthritis (RA) will complete a 12-week RA-tailored remotely supervised and delivered moderate to vigorous intensity aerobic training combined with resistance training exercise program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Persons with early RA - defined as duration of diagnosis equal to or less than 6 months, and not currently taking biologic DMARD therapy. Participants may be on one or a combination of the following conventional synthetic DMARDs: hydroxychloroquine, methotrexate, sulfasalazine, leflunomide, azathioprine
- 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
- Active RA, not in clinical disease remission (Clinical Disease Activity Index for RA (CDAI) > 2.8)
- Stable doses (for ≥ 1 month) of all RA and cardiovascular risk-related medications (including statins, metformin, SGLT2 inhibitors, GLP1RA) except for glucocorticoids
Key exclusion criteria (10 listed)
- Pregnant or intending to become pregnant during the intervention period
- Current treatment with exogenous insulin
- Other inflammatory arthropathy or myopathy, Paget's disease, pigmented villonodular synovitis, joint infection, ochronosis, neuropathic arthropathy, osteochondromatosis, acromegaly, hemochromatosis, or Wilson's disease
- Current malignancy other than minimally invasive carcinomas routinely treated topically or with minor surgical treatment
- Absolute contraindications to exercise testing: ongoing unstable angina; uncontrolled cardiac arrhythmia with hemodynamic compromise; active endocarditis; symptomatic severe aortic stenosis; decompensated heart failure; acute pulmonary embolism, pulmonary infarction, or deep vein thrombosis; acute myocarditis or pericarditis; acute aortic dissection; physical disability that precludes safe and adequate testing
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 |
|---|---|---|
| TRAINERa intensive exercise trainingRemotely-delivered exercise training intervention | Behavioural | TRAINERa intensive exercise training |
Primary outcome
Feasibility of exercise training intervention
Time frame: The primary feasibility target is participant adherence to the intervention protocol exercise prescription averaged over the course of the final 6 weeks of the 12-week program > 60%.
Feasibility will be measured as a dichotomous outcome through patient adherence, defined as meeting 100% of the prescribed exercise protocol, on average.
2 secondary outcomes
Acceptability of exercise training intervention
Time frame: 12 weeks
Safety of exercise training intervention
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Background: PubMed 38126260Andonian BJ, Ross LM, Sudnick AM, Johnson JL, Pieper CF, Belski KB, Counts JD, King AP, Wallis JT, Bennett WC, Gillespie JC, Moertl KM, Richard D, Huebner JL, Connelly MA, Siegler IC, Kraus WE, Bales CW, Porter Starr KN, Huffman KM. Effect of Remotely Supervised Weight Loss and Exercise Training Versus Lifestyle Counseling on Cardiovascular Risk and Clinical Outcomes in Older Adults With Rheumatoid Arthritis: A Randomized Controlled Trial. ACR Open Rheumatol. 2024 Mar;6(3):124-136. doi: 10.1002/acr2.11639. Epub 2023 Dec 21.
- Individual participant dataSharing planned: Yes. New clinical data will be collected from 15 participants with rheumatoid arthritis before and after a 12-week exercise training intervention. All de-identified individual participant data (including demographic, clinical and immune cell data) will be deposited into a NIH supported public repository. Adequate information will be retained to generate a unique identifier for each study participant.
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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.
Brian J Andonian, MD, MHSc principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TRAINERa intensive exercise training 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 5 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 19 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Johanna Johnson, MS (19196606766, johanna.johnson@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of exercise training intervention (time frame: The primary feasibility target is participant adherence to the intervention protocol exercise prescription averaged over the course of the final 6 weeks of the 12-week program > 60%.). 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 NCT06841562, which also lists 1 linked publication.
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 19 Mar 2026.