Duke University
Durham, North Carolina, 27710, United States
Location status: Recruiting
Location contact
Alyssa Sudnick, MS
CONTACT
Brian J Andonian, MD, MHSc
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06841562
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Durham, North Carolina, 27710, United States
Location status: Recruiting
Alyssa Sudnick, MS
CONTACT
Brian J Andonian, MD, MHSc
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Remotely-delivered 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.
Time frame: 12 weeks
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.
Time frame: 12 weeks
Safety will be measured by adverse events and serious adverse events.
Contact information is provided by the study sponsor or research team.
Brian J Andonian, MD, MHSc
CONTACT
Johanna Johnson, MS
CONTACT
Duke University
Other
Targeted Remotely-delivered Anti-inflammatory Interventions With Exercise for Rheumatoid Arthritis - Early Rheumatoid Arthritis Pilot Study
Acronym: TRAINERa
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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