Multiple Sclerosis Clinical Trial
Official title:
Cardiovascular Fitness and the Influence of a Controlled Combined Exercise Program on Fatigue and Depression of Newly Diagnosed Patients With Multiple Sclerosis
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.
Status | Recruiting |
Enrollment | 70 |
Est. completion date | December 31, 2025 |
Est. primary completion date | June 30, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 45 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Czechia | University Hospital Ostrava | Ostrava | Moravian-Silesian Region |
Lead Sponsor | Collaborator |
---|---|
University Hospital Ostrava |
Czechia,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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 | |
Primary | Maximal aerobic capacity (VO2max.kg-1) | Change after six months follow up in conventional, experimental and control group | 6 months | |
Primary | Power to weight ratio (W.kg-1) | Change after six months follow up in conventional, experimental and control group | 6 months | |
Secondary | 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 | |
Secondary | Symptom-Checklist-90-Standard (SCL-90-S) | Change in result of percentile score | 6 months | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Maximal heart rate (bpm) | Change after six months follow up in conventional, experimental and control group | 6 months | |
Secondary | Heart rate variability (ms) | Change after six months follow up in conventional, experimental and control group | 6 months | |
Secondary | Body composition analysis %) | Body composition (fat, water, muscle, bone mass) analysis will be performed in study subjects and expressed as per cent. | 6 months |
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