Pending: Are muscle characteristics associated with the effect of exercise training on muscle strength in rheumatic diseases and sarcopenia? - an explorative study: The Care for Muscle (C4M) Study

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Trial Status Pending
Overall study start date
Overall study end date
Country The Netherlands
Trial Number NL86908.018.24
Trial URL https://onderzoekmetmensen.nl/en/trial/57399
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. This response is related to various clinical, blood-based, and muscle metabolic and architectural biomarkers and the clinical diagnosis, i.e., rheumatoid arthritis (RA), osteoarthritis (OA), and sarcopenia alone (SARC). Understanding the underlying biochemical muscle characteristics of each diagnosis group can help to develop more targeted training in making it more effective.
Study Design two-arm parallel-group exploratory trial including a total of 69 patients
Study Setting(s) Hospital
Study Acronym C4M
Study Hypotheses 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.
Condition Rheumatoid arthritis
Intervention Exercise intervention 2 times a week for 8 weeks on location and once a week at home.
Primary Outcome Measure The primary study parameter is the difference in isokinetic muscle strength pre- and post-intervention in all three patient groups. Quadriceps strength (isokinetic, BIODEX).
Secondary Outcome Measure

A set of biomarkers obtained by muscle biopsy and blood that characterize muscle quality in terms of energy management, histology (architecture), gene expression and inflammation.

  • Feasibility: therapy adherence, drop-out rate, user satisfaction, Net Promoter score (Reichheld 2003)
  • Subject characteristics: age, gender, height, weight, comorbidity (CIRS), medication, educational level, employment, marital status, smoking and alcohol use, duration symptoms, use of walking devices
  • Anthropometrics: BMI, absolute & relative muscle mass (Bio Impedance Analysis). Short-form mini-nutritional assessment (MNA-SF, Rubenstein 2001).
  • Disease characteristics: diagnosis, radiologic severity RA/OA
  • Performance: Muscle endurance (Biodex), Handgrip strength (JAMAR), Short Physical Performance Battery (SPPB), Six Minute Walking Test (6MWT), FITMAX survey (Meijer 2021), PROMIS short form-CAT pain, fatigue, physical function, social function.
  • Muscle architecture (by ultrasound): Volume, CSA, muscle pennation angle, fascicle length.

Eligibility

Participant Type(s) Rheumatoid arthritis
Age Group Adolescent / Teen (12-17 years), Adult (18-64)
Sex Both
Target Number of Participants 69
Total Final Enrolment
Participant Inclusion Criteria For all patients: Willingness and motivation to exercise. Low muscle strength defined as hand grip strength (HGS) 27 kg and 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). Osteoarthritis patients - Ages between 50 and 70 - Patients with either knee and/or hip osteoarthritis according to clinical American College of Rheumatology criteria (Altman 1986). - Kellgren and Lawrence (K&L) grading score of 2-4 for hip and/or knee OA. - C-reactive Protein (CRP) levels 10mg/L within 3 months prior to enrolment Rheumatoid arthritis patients - Ages between 50 and 70 - Diagnosed with RA according to EULAR/ ACR criteria (Aletaha 2010). - Disease activity score (DAS28) 2.81 year and Sarcopenia patients - Ages between 50 and 80. - Sarcopenia without joint involvement (no OA, RA), according to the EWGSOPII criteria (Cruz Jentoft 2019) of low muscle strength defined as hand grip strength (HGS) d sarcopenia (appendicular muscle Lean Mass (ALM)/height2 s no selection criterion. Severe sarcopenia will be excluded (gait speed nt disease).
Participant Exclusion Criteria BMI 35 Kg/m2 Contra-indications for exercise testing and prescription are on the basis of theanswers from the *physical activity readiness questionnaire* (PAR-Q) and familiarity(by self-report) of the following heart conditions: heart failure symptoms, myocardialinfarction less than three months before the start of the training program anddiagnosed with other cardiac diseases Participants taking beta-blockers for the duration of the intervention. Diagnosed with other neurologic or cachectic diseases or major surgery that may interfere with muscle quality (i.e. multiple sclerosis, ongoing cancer treatment or radiotherapy/ chemotherapy in the previous 6 months). Participating in another regular and intense (> 2 times a week) physical training programme within 2 months prior to enrolment. Ligament/muscle tear and/or other injuries within 6 months. Taking drugs (e.g. performance enhancing drugs) or nutritional supplements (e.g. protein powder) known to increase muscle mass. Inability to be scheduled for exercise therapy Insufficient comprehension of Dutch language or no informed consent.