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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05671588
Other study ID # 01/RVO-FNOs/2022
Secondary ID 01/RVO-FNOs/2022
Status Recruiting
Phase N/A
First received
Last updated
Start date May 1, 2022
Est. completion date December 31, 2025

Study information

Verified date January 2024
Source University Hospital Ostrava
Contact Jirí Hyncica
Phone 0042059737
Email jiri.hyncica@fno.cz
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Controlled combined exercise group
Patients will undergo protocol-defined combined aerobic-resistant therapy on a cycling ergometer and multifunctional fitness device
Conventional rehabilitation
Patients will undergo conventional rehabilitation.

Locations

Country Name City State
Czechia University Hospital Ostrava Ostrava Moravian-Silesian Region

Sponsors (1)

Lead Sponsor Collaborator
University Hospital Ostrava

Country where clinical trial is conducted

Czechia, 

References & Publications (4)

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

Outcome

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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