Multiple Sclerosis
Conditions
Keywords
Multiple Sclerosis, Controlled combined exercise, Cardiovascular fitness, Fatigue, Depression
Brief summary
This study is focused on patients with multiple sclerosis (MS), their cardiovascular fitness, and the effect of combined controlled training on the perception of fatigue, the development of depression, and quality of life in the first year after diagnosis.
Detailed description
The main goal is to find out if fatigue, depression, and quality of life depend on the type of training as well as controlled management of newly diagnosed patients. Fatigue is one of the frequent disabling symptoms and the most difficult to influence pharmacologically. It could lead to inactivity and the progression of deconditioning. We know from systematic reviews that aerobic activity leads to improvement in fatigue, however, there are also opinions about exercise intolerance due to disruption of cardiac autonomy control. The investigators will try to determine whether early rehabilitation intervention leads to support and motivation of patients with an incurable chronic neurodegenerative disease to improve the patient condition and contentment. The researchers will focus on effective training by comparing the study group with a control group of patients undergoing conventional rehabilitation versus a protocol-defined controlled combined (aerobic-resistant) exercise program - based on the results of spiroergometry. Both groups will be treated at ambulatory sections by protocol-defined rehabilitation for a 1-hour duration, twice a week for one month, and once a week for the next month (12 therapies in total). The control group will be educated in exercises according to kinesiological analysis to do regularly at home. Finally, the researchers will see if early intervention leads to a change in the active approach of probands.
Interventions
PROCEDUREConventional rehabilitation
Patients will undergo conventional rehabilitation.
PROCEDUREControlled combined exercise group
Patients will undergo protocol-defined combined aerobic-resistant therapy on a cycling ergometer and multifunctional fitness device
Sponsors
University Hospital Ostrava
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
All participants of the study will undergo a clinical examination including a questionnaire survey and spiroergometry - examiners will not have access to intervention documents before and after the intervention (period of 6 months), as well as examiners will not perform the therapy.
Intervention model description
The study subjects will be enrolled into two parallel groups.
Eligibility
Sex/Gender
ALL
Age
20 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Age 20 - 45 years * Newly diagnosed patients with multiple sclerosis * Relapsing-remitting MS (RRMS) or clinically isolated syndrome (CIS) * EDSS 0-6 * Signed informed consent
Exclusion criteria
* Progressive forms of MS (PRMS or SPMS), Malignant MS * Non-cooperation, disagreement with the study * Contraindication to spiroergometry
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Power to weight ratio (W.kg-1) | 6 months | Change after six months follow up in conventional, experimental and control group |
| Maximal aerobic capacity (VO2max.kg-1) | 6 months | Change after six months follow up in conventional, experimental and control group |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Symptom-Checklist-90-Standard (SCL-90-S) | 6 months | Change in result of percentile score |
| Beck Depression Inventory Score II (BDI II) | 6 months | Self-reported rating inventory that measures characteristic attitudes and symptoms of depression, 0-13 - minimal or none depression, 29-63 - severe depression |
| 36-Item Short Form Survey (SF-36) | 6 months | Self-reported measure of health-related quality of life, minimum 0 points, maximum 100 points - the higher score is the sign of better quality of life |
| Heart rate variability (ms) | 6 months | Change after six months follow up in conventional, experimental and control group |
| Body composition analysis %) | 6 months | Body composition (fat, water, muscle, bone mass) analysis will be performed in study subjects and expressed as per cent. |
| Maximal heart rate (bpm) | 6 months | Change after six months follow up in conventional, experimental and control group |
| Modified Fatigue Impact Scale (MFIS) | 6 months | Self-reported measure of level of fatigue, minimum 0 points, maximum 84 points - the less score means less fatigue |
Other
| Measure | Time frame | Description |
|---|---|---|
| Cost-benefit analysis of early rehabilitation intervention (CZK) | 6 months | Cost-benefit analysis of early rehabilitation intervention will be performed and expressed as the price in Czech crowns (CZK). |
Countries
Czechia
Contacts
Primary ContactJiří Hynčica
Outcome results
None listed