Cardiorespiratory fitness in newly diagnosed patients with Relapsing Remitting Multiple Sclerosis compared to matched healthy controls: already lagging behind from the start?
- Conditions
- Multiple Sclerosis (MS)10012303
- Registration Number
- NL-OMON48103
- Lead Sponsor
- Vrije Universiteit Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 32
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
- 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.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Maximal exercise capacity, lung function, and mitochondrial function of<br /><br>muscles.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Blood parameters: Haemoglobin concentration, hematocrit, C-reactive protein<br /><br>(CRP).</p><br>