This pilot study aims to explore whether and why the cardiorespiratory fitness is compromised in newly diagnosed patients with early Relapsing Remitting Multiple Sclerosis (RRMS) with no or minimal clinical symptoms (i.e. Expanded Disability Status…
ID
Source
Brief title
Condition
- Demyelinating disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Maximal exercise capacity, lung function, and mitochondrial function of
muscles.
Secondary outcome
Blood parameters: Haemoglobin concentration, hematocrit, C-reactive protein
(CRP).
Background summary
Scientific evidence consistently shows reduced cardiorespiratory fitness in
people with Multiple Sclerosis (MS) compared to healthy peers. It is often
suggested that this is caused by the fact that MS patients have an
inactivity-related physiological profile caused by a more sedentary lifestyle
compared to healthy controls. However, in keeping with a recent Norwegian study
showing that reduced cardiorespiratory fitness increases the susceptibility to
develop MS and clinical observations, it is hypothesized that low
cardiorespiratory fitness is already present at the onset of the disease and is
thus not the result of neurodegenerative disease course. Cardiorespiratory
fitness depends on the functional integration of the cardiovascular,
respiratory, and skeletal muscle system. It is therefore important to examine
in early MS how each step of the oxygen transport pathway contributes to
cardiorespiratory deconditioning, and whether explanatory modifiable
determinants of reduced cardiorespiratory fitness can be found.
Study objective
This pilot study aims to explore whether and why the cardiorespiratory fitness
is compromised in newly diagnosed patients with early Relapsing Remitting
Multiple Sclerosis (RRMS) with no or minimal clinical symptoms (i.e. Expanded
Disability Status Scale (EDSS) score 0-2 and normal pyramidal and cerebellar
functions) compared to matched healthy siblings or other matched healthy
controls.
Study design
Observational case-control study with a cross-sectional design
Study burden and risks
There will be one enrolment consultation of 1 hour. After inclusion, the
measurements (2 times in 2 weeks) will take approximately 2 hours each to
complete. The risks and burden will be related to the testing procedures, i.e.
cardiopulmonary exercise testing, lung function examination, muscle biopsy, and
blood sampling. It should be noted that all these are common clinical
diagnostic procedures, and proven to be safe (in patients with MS). There is no
direct benefit of study participation. Participants will, however, contribute
to increasing knowledge and insight of exercise tolerance in patients with
early MS. The risk-classification for this non-intervention study is
*negligible*.
De Boelelaan 1118
Amsterdam 1081 HZ
NL
De Boelelaan 1118
Amsterdam 1081 HZ
NL
Listed location countries
Age
Inclusion criteria
MS patients
In order to be eligible to participate in this study, the MS patients must meet all of the following criteria:
- definite diagnosis of Relapsing Remitting MS according to the most recent international diagnostic criteria;
- diagnosis within 12 months prior to inclusion date;
- disease severity: EDSS score of maximal 2 with normal pyramidal and cerebellar functions (i.e. Functional Systems Score for pyramidal functions = 0 and Functional Systems Score for cerebellar functions = 0).
- age at definite diagnosis between 18-65 years.
Healthy Siblings/Controls (controls)
In order to be eligible to participate in this study, the healthy controls must meet the following criteria:
- healthy sibling of participant with MS, and matching with respect to sex, age (± 5 years), level of physical activity in the past year;
- healthy persons, matching to MS participants with respect to sex, age (± 5 years), and level of physical activity in the past year.
- age between 18-65 years
Exclusion criteria
- Physician-confirmed diagnosis of (other) neurological disorders or systemic or malignant neoplastic diseases.
- Serious comorbidities precluding Cardiopulmonary Exercise test (CPET) or Lung function examination.
- Use of heart rate regulating medication (e.g. Beta-blockers).
- Use of medication for lung diseases.
- Being pregnant, or receiving medical help/fertility treatment to become pregnant.
- Body Mass Index of 30 or higher.
- Sports and exercise activities in the past year of > 10 hours/week.
- Does not speak Dutch.
Design
Recruitment
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 | NL67705.029.18 |