In this exploratory study we aim:1) To identify the confounding factors in qMRI analysis (e.g. age, gender, body composition)2) To determine the relation between qMRI parameters and muscle force and function taking into account the confounding…
ID
Source
Brief title
Condition
- Muscle disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measures are isometric and isokinetic muscle force and the
obtained qMRI parameters:
- Muscle fat fraction, muscle volume, muscle length, and muscle shape assessed
with a Dixon sequence.
- T2 relaxation time of muscle water (T2water) assessed with a multi-slice
multi spin echo sequence.
- Mean diffusivity, fractional anisotropy, estimated muscle fibre length,
muscle pennation angle and physiological cross-sectional area assessed with a
diffusion weighted sequence.
Other study parameters are the potential confounders in qMRI, like age, body
weight, height, and composition, daily-life activity levels, and smoking and
drinking history.
Secondary outcome
n.a.
Background summary
Neuromuscular diseases are characterized by progressive muscle wasting, leading
to disability, significant reduction of quality of life, or even death.
Magnetic resonance imaging (MRI) allows non-invasive, quantitative evaluation
of muscle architecture, status, and microstructure in those patients. However,
although sensitive, quantitative MRI (qMRI) parameters often lack specificity
and are not linked to muscle function. Furthermore, the within-group variance
in qMRI parameters is large, which requires large sample sizes in clinical
trials. This is a problem in rare diseases, like neuromuscular disorders.
Identifying the confounding factors that lead to this within-group variance and
accounting for these factors in qMRI muscle analysis will reduce the needed
samples size and will allow better patient-specific evaluation of disease
progression and effect of therapy.
Study objective
In this exploratory study we aim:
1) To identify the confounding factors in qMRI analysis (e.g. age, gender, body
composition)
2) To determine the relation between qMRI parameters and muscle force and
function taking into account the confounding factors determined in aim 1.
Study design
This is an observational cohort study. Study assessments include an MRI scan
and muscle strength measurements of the lower extremity, a body composition
measurement with bioimpedance, and questionnaires on daily-life activity and
life-style.
Study burden and risks
The participants will undergo one 60 minute MRI scan. This involves risks
regarding to claustrophobia and back pain due to laying in supine position.
Furthermore, the participants needs to perform muscle strength measures, which
can lead to muscle soreness the day after. There will be no direct benefit for
the participants themselves. The work will allow us to better study muscle
changes in patients who suffer from diseases affecting muscles, and will be of
interest for the evaluation of injuries and recovery in athletes.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
• Age between 16 and 60 years old
• BMI between 18 and 30 kg/m2
Exclusion criteria
• History of neuromuscular disease
• Contra-indications for undergoing an MRI scan (e.g. because of pacemaker,
claustrophobia, metal implants, metal splinters in the eye)
• Inability to lie supine for 60 minutes
• Inability to perform knee extension or knee flexion
• Contra-indications for physical exercise without prior consultation
with a physician verified using the Physical Activity Readiness Questionnaire
(PAR-Q).
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 | NL82307.041.22 |