Innovation of MR based assessment of muscle function during in-magnet exercise
- Conditions
- Muscle disordersAgeing10028302
- Registration Number
- NL-OMON53413
- Lead Sponsor
- Amsterdam UMC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 178
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
• 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
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>For the muscle oxidative capacity the main endpoints are the repeatability of/<br /><br>and sensitivity to changes in high-energy phosphate metabolites, including<br /><br>adenosine triphosphate (ATP), phosphocreatine (PCr), inorganic phosphate (Pi),<br /><br>myofiber pH and T2* relaxation times measured at rest, during a supine cycling<br /><br>test and during recovery. The main endpoints for the assessment of muscle<br /><br>contractile function are the feasibility of/ repeatability of/ and sensitivity<br /><br>to changes of the strain rate and strain rate distributions along and<br /><br>perpendicular to the fibers measured during knee-flexion & -extension exercise.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary study parameters:<br /><br><br /><br>• Muscle Morphology measures using qMRI (Muscle volumes; Fat fractions;<br /><br>architectural parameters, diffusion measures; water T2 relaxation times)<br /><br>• Hand grip strength<br /><br>• Motor function tests (e.g. KATZ score, SPPB, IADL, TUG)<br /><br>• BMI (height & weight)<br /><br>• Blood pressure<br /><br>• 7-day Activity levels<br /><br>• Questionnaires (e.g. fall history, co-morbidities(CIRS), mental functioning<br /><br>(MOCA), daily life activities (IPAQ), feasibility of the in-magnet exercises)</p><br>