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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TRAINERa intensive exercise training | Behavioral | Remotely-delivered exercise training intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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%. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 weeks |
| Safety of exercise training intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Johanna Johnson, MS | Contact | 19196606766 | johanna.johnson@duke.edu | |
| Brian J Andonian, MD, MHSc | Contact | 19196606743 | brian.andonian@duke.edu |
| Name | Affiliation | Role |
|---|---|---|
| Brian J Andonian, MD, MHSc | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University | Recruiting | Durham | North Carolina | 27710 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38126260 | Background | 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. |
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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.
All scientific data from this project will be made available by the end of the award period or time of associated publication, whichever comes first.
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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Safety will be measured by adverse events and serious adverse events. |
| 12 weeks |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |