Effect of Exercise Type on Muscle Quality in Patients With OA, SARC and RA: an Explorative Study (NCT06480643) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Effect of Exercise Type on Muscle Quality in Patients With OA, SARC and RA: an Explorative Study
69 participantsStarted 2024-12-01
Plain-language summary
C4M hypothesizes that patients with low muscle strength may respond differently to different types of exercise intervention, dependent on the underlying aetiology, i.e. impaired protein synthesis versus metabolic dysfunction and that this response is predictable based on the clinical diagnosis, i.e. rheumatoid arthritis (RA), osteoarthritis (OA) and Sarcopenia alone (SARC) and a number of clinical, blood based and muscle metabolic and architectural biomarkers. Understanding the underlying biochemical response of each patient group to the different type of exercise loading could help with the development of disease-specific training, making it more effective and more predictable on outcomes.
Who can participate
Age range
50 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria For all patients
* Low muscle strength defined as hand grip strength (HGS) \<27 kg and \<16 kg for males and females respectively. If HGS is not possible due to interfering pain or joint- deformity, the chair stand test is used instead, with low muscle strength defined as not able to rise from the chair without arms or a time \>15 sec (Cruz Jentoft 2019).
* Gait speed of \>0.8m/s to exclude patients who are too disabled to participate in the study (Cruz Jentoft 2019).
OA patients
* Age between 50 and 70
* Patients with either knee and/or hip OA according to clinical American College of Rheumatology (ACR) criteria (Altman 1986).
* Kellgren and Lawrence grading score of 2-4 for hip and/or knee OA (Altman 1991).
* C-reactive Protein (CRP) levels \<10mg/L within 3 months prior to enrolment (Sanchez 2014).
Rheumatoid arthritis patients
* Age between 50 and 70
* Diagnosed with RA according to European Alliance of Associations for Rheumatology (EULAR)/ACR criteria (Aletaha 2010).
* Disease activity score in 28 joints (DAS28) 2.8\<5.6, as defined by the EULAR criteria (Aletaha 2010), either de novo or despite Disease-Modifying Antirheumatic Drug therapy.
* Stable disease three months prior to the start of the exercise intervention.
* Stable rheumatic medication three months prior to the start of the exercise intervention.
* Stopped the usage of corticosteroids 3 months prior to the start of the exercise intervention.
*…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Isokinetic muscle strength in Nm/kg
Timeframe: Measured before and after the 8 week- exercise block.