An interventional study of Controlled combined exercise group and Conventional rehabilitation in Multiple Sclerosis, sponsored by University Hospital Ostrava. Recruiting at 1 site in Czechia. Open to participants aged 20 Years to 45 Years. Per ClinicalTrials.gov, last updated 2024-01-16.
Sponsored by University Hospital Ostrava · Not applicable, Interventional, and Prevention
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.
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.
3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.
This study's planned enrollment of 70 is above the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →University Hospital Ostrava is the lead sponsor of 146 studies on the registry; 50 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients randomized into the Experimental arm will undergo controlled exercise on a cycling ergometer in combination with strength training on a multifunctional fitness device for 1-hour duration, twice a week for one month, and once a week for the next month (12 therapies in total).
Procedure: Controlled combined exercise group
Patients randomized into this study arm will undergo conventional rehabilitation.
Procedure: Conventional rehabilitation
Patients randomized into this study arm will undergo no intervention and will serve as the control group.
Patients will undergo protocol-defined combined aerobic-resistant therapy on a cycling ergometer and multifunctional fitness device
Patients will undergo conventional rehabilitation.
Maximal aerobic capacity (VO2max.kg-1)
Change after six months follow up in conventional, experimental and control group
Time frame: 6 months
Power to weight ratio (W.kg-1)
Change after six months follow up in conventional, experimental and control group
Time frame: 6 months
Modified Fatigue Impact Scale (MFIS)
Self-reported measure of level of fatigue, minimum 0 points, maximum 84 points - the less score means less fatigue
Time frame: 6 months
Symptom-Checklist-90-Standard (SCL-90-S)
Change in result of percentile score
Time frame: 6 months
Beck Depression Inventory Score II (BDI II)
Self-reported rating inventory that measures characteristic attitudes and symptoms of depression, 0-13 - minimal or none depression, 29-63 - severe depression
Time frame: 6 months
36-Item Short Form Survey (SF-36)
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
Time frame: 6 months
Maximal heart rate (bpm)
Change after six months follow up in conventional, experimental and control group
Time frame: 6 months
Heart rate variability (ms)
Change after six months follow up in conventional, experimental and control group
Time frame: 6 months
Body composition analysis %)
Body composition (fat, water, muscle, bone mass) analysis will be performed in study subjects and expressed as per cent.
Time frame: 6 months
Cost-benefit analysis of early rehabilitation intervention (CZK)
Cost-benefit analysis of early rehabilitation intervention will be performed and expressed as the price in Czech crowns (CZK).
Time frame: 6 months
Plan to share: No — There is no plan to make individual participant data available to other researchers. The data may be provided upon request.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University Hospital Ostrava