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| ID | Type | Description | Link |
|---|---|---|---|
| 01/RVO-FNOs/2022 | Other Grant/Funding Number | University Hospital Ostrava |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Controlled combined program (aerobic-resistant) | Experimental | 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). |
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| Conventional rehabilitation | Active Comparator | Patients randomized into this study arm will undergo conventional rehabilitation. |
|
| No intervention | No Intervention | Patients randomized into this study arm will undergo no intervention and will serve as the control group. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Controlled combined exercise group | Procedure | Patients will undergo protocol-defined combined aerobic-resistant therapy on a cycling ergometer and multifunctional fitness device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximal aerobic capacity (VO2max.kg-1) | Change after six months follow up in conventional, experimental and control group | 6 months |
| Power to weight ratio (W.kg-1) | Change after six months follow up in conventional, experimental and control group | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Modified Fatigue Impact Scale (MFIS) | Self-reported measure of level of fatigue, minimum 0 points, maximum 84 points - the less score means less fatigue | 6 months |
| Symptom-Checklist-90-Standard (SCL-90-S) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 6 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiří Hynčica | Contact | 0042059737 | 2587 | jiri.hyncica@fno.cz |
| Name | Affiliation | Role |
|---|---|---|
| Anna Šilarová, MD | University Hospital Ostrava | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Ostrava | Recruiting | Ostrava | Moravian-Silesian Region | 708 52 | Czechia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32169035 | Background | Razazian N, Kazeminia M, Moayedi H, Daneshkhah A, Shohaimi S, Mohammadi M, Jalali R, Salari N. The impact of physical exercise on the fatigue symptoms in patients with multiple sclerosis: a systematic review and meta-analysis. BMC Neurol. 2020 Mar 13;20(1):93. doi: 10.1186/s12883-020-01654-y. | |
| 33901439 | Background |
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There is no plan to make individual participant data available to other researchers. The data may be provided upon request.
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D005221 | Fatigue |
| D003863 | Depression |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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The study subjects will be enrolled into two parallel groups.
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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.
| Conventional rehabilitation | Procedure | Patients will undergo conventional rehabilitation. |
|
Change in result of percentile score
| 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 | 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 | 6 months |
| Maximal heart rate (bpm) | Change after six months follow up in conventional, experimental and control group | 6 months |
| Heart rate variability (ms) | Change after six months follow up in conventional, experimental and control group | 6 months |
| Body composition analysis %) | Body composition (fat, water, muscle, bone mass) analysis will be performed in study subjects and expressed as per cent. | 6 months |
| Taul-Madsen L, Connolly L, Dennett R, Freeman J, Dalgas U, Hvid LG. Is Aerobic or Resistance Training the Most Effective Exercise Modality for Improving Lower Extremity Physical Function and Perceived Fatigue in People With Multiple Sclerosis? A Systematic Review and Meta-analysis. Arch Phys Med Rehabil. 2021 Oct;102(10):2032-2048. doi: 10.1016/j.apmr.2021.03.026. Epub 2021 Apr 24. |
| 25634170 | Background | Cruickshank TM, Reyes AR, Ziman MR. A systematic review and meta-analysis of strength training in individuals with multiple sclerosis or Parkinson disease. Medicine (Baltimore). 2015 Jan;94(4):e411. doi: 10.1097/MD.0000000000000411. |
| 24603938 | Background | Hansen D, Wens I, Keytsman C, Eijnde BO, Dendale P. Is long-term exercise intervention effective to improve cardiac autonomic control during exercise in subjects with multiple sclerosis? A randomized controlled trial. Eur J Phys Rehabil Med. 2015 Apr;51(2):223-31. Epub 2014 Mar 6. |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |