Cardiovascular Fitness of Patients With Multiple Sclerosis, Effect of Exercise on Fatigue and Depression

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

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
• 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
• 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

Related Conditions & MeSH terms

• Depression
• Fatigue
• Multiple Sclerosis
• Sclerosis

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