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Innovation of MR based assessment of muscle function during in-magnet exercise

Innovation of MR based assessment of muscle function during in-magnet exercise - Novel Dynamic MRI acquisitions to study muscle function

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON53413
Enrollment
178
Registered
2023-02-06
Start date
2023-01-01
Completion date
Unknown
Last updated
2024-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Muscle disorders

Interventions

None listed

Sponsors

Amsterdam UMC
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients with sarcopenia. In order to be eligible to participate in this study, a participant must meet the following criteria: • Non-hospitalized individuals • Ability to follow test instructions • Age above 65 years • Diagnosed with Sarcopenia according to the SARC-F questionnaire and handgrip Strength Patients with neuromuscular diseases In order to be eligible to participate in this study, a patient must meet the following criteria: • Confirmed NMD diagnosis • Referral to supervised exercise rehabilitation program • Ability to follow test instructions • Non-hospitalized individuals • Age > 18 years Athletes with hamstring injury In order to be eligible to participate in this study, an athlete must meet the following criteria: • Anamnestic pain in posterior thigh • Localised pain during palpation of hamstring muscle • Localised pain during passive straight leg raising • Increasing pain during isometric contraction • Age> 18 years old Control participants In order to be eligible to participate in this study, a participant must meet the following criteria: • Non-hospitalized individuals • Ability to follow test instructions • Age> 18 years

Exclusion criteria

Exclusion criteria: • Inability to provide informed consent • Have a history of claustrophobia • Patients/ participant is not eligible to perform the exercise test described in this study protocol or follow instructions • Contra-indication for MRI (e.g., pacemaker, Claustrophobia; See F1 vragenlijsten screening MRI Amsterdam UMC) • Muscle injury in the 6 months prior to participation in this study (Except for the athletes) • Being under investigation for non-diagnosed disease at the time of investigation • Risk factors for exercise testing registered by a Dutch version of the pre-participation questionnaire (American college of sports medicine and American Heart association). Possible risk factors will be discussed with a medical specialist or general practitioner before a subject can be included. Specific exclusion criteria for adults with Neuromuscular disease • Engaged in an exercise program for a period longer than 4 weeks in the past 6 months. • Participants with variably of rapidly progressive NMD, characterized by muscle impairment that worsens over months, e.g. amyotrophic lateral sclerosis. • Participants who are not stable on medication. • Participants with cardio-pulmonary involvement. Specific exclusion criteria for Athletes with hamstring injury: • Cause of the hamstring injury is an extrinsic trauma of the posterior thigh • Patient does not have the intention to return to full sports activity

Design outcomes

Primary

MeasureTime frame
For the muscle oxidative capacity the main endpoints are the repeatability of/ and sensitivity to changes in high-energy phosphate metabolites, including adenosine triphosphate (ATP), phosphocreatine (PCr), inorganic phosphate (Pi), myofiber pH and T2* relaxation times measured at rest, during a supine cycling test and during recovery. The main endpoints for the assessment of muscle contractile function are the feasibility of/ repeatability of/ and sensitivity to changes of the strain rate and strain rate distributions along and perpendicular to the fibers measured during knee-flexion & -extension exercise.

Secondary

MeasureTime frame
Secondary study parameters: • Muscle Morphology measures using qMRI (Muscle volumes; Fat fractions; architectural parameters, diffusion measures; water T2 relaxation times) • Hand grip strength • Motor function tests (e.g. KATZ score, SPPB, IADL, TUG) • BMI (height & weight) • Blood pressure • 7-day Activity levels • Questionnaires (e.g. fall history, co-morbidities(CIRS), mental functioning (MOCA), daily life activities (IPAQ), feasibility of the in-magnet exercises)

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)