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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
70
Patients will undergo protocol-defined combined aerobic-resistant therapy on a cycling ergometer and multifunctional fitness device
Patients will undergo conventional rehabilitation.
University Hospital Ostrava
Ostrava, Moravian-Silesian Region, Czechia
RECRUITINGMaximal 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
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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