to determine the feasibility, repeatability and sensitivity of our newly developed non-invasive dynamic MR acquisitions to study muscle contractile function and muscle oxidative capacity during dynamic exercise. Muscle oxidative capacity will be…
ID
Source
Brief title
Condition
- Muscle disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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)
Background summary
Sarcopenia is a recently-classified disease that is characterized by the
progressive loss of skeletal muscle mass and function, which typically occurs
from middle-age onwards. Its increasing prevalence is becoming a major societal
problem, given its associations with frailty, falls, fractures, and
hospitalization. The etiology of impaired muscle function with increasing age
is multifactorial, with both muscle strength and muscle oxidative capacity
being important contributors. However, the currently available techniques to
measure underlying factors influencing muscle function are invasive or lack
specificity with respect to contribution of individual muscle. More insight in
the underlying factors contributing to impaired muscle function with increasing
age, will help to further optimize exercise, dietary and/or pharmacological
interventions.
Study objective
to determine the feasibility, repeatability and sensitivity of our newly
developed non-invasive dynamic MR acquisitions to study muscle contractile
function and muscle oxidative capacity during dynamic exercise. Muscle
oxidative capacity will be measured during a supine cycling test using
interleaved T2* mapping and phosphorous magnetic resonance spectroscopy (31P
MRS) acquisitions. Muscle contractile function will be measured using
time-resolved 3D phase contrast acquisitions during a knee flexion and
extension test.
Study design
2-way prospective observational feasibility and repeatability study
Study burden and risks
Participants will be asked to visit the hospital one or two times. During
these visits a static and dynamic MRI acquisition are performed in rest and
during in-magnet exercise. A selection of the participants will also be asked
to perform some functional tests, fill-out questionnaires and collect wearable
data for a period of 7-days. There are no medical risks associated with this
study. The MRI scan is safe and painless. An MRI scan does not cause radiation
and no drugs will be administered. The scanner does make a lot of noise, so we
will give you hearing protection to reduce the noise. Some people find lying in
the MRI scanner uncomfortable. The exercise test done during the second part of
the MRI scan may cause some muscle fatigue. A hospital staff member will be
constantly present and in touch while you are in the scanner, and if you are
uncomfortable the scanning can be stopped. There are no known risks associated
with answering the questionnaires or performing the functional tests. After
performing the functional tests, the muscles may feel a little tired. There is
a significant time investment on behalf of the participants, since participants
are required to visit the institute on one or two occasions. The visits range
in duration from 1.5 to 4.5 hours per session. Participants will receive
personal feedback of their results, this will not directly lead to better
health care or health care advice. Participants will receive reimbursement for
their travel and parking costs. Participants have no direct benefit by
participating in this study. A group-related benefit of this observational
study is that in the future dynamic MR acquisitions might become a valuable
tool in research and management of impaired muscle function in ageing,
sarcopenia, muscle disease and mapping the recovery of muscle injuries.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
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
• 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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL82616.018.22 |