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

NCT ID: NCT05671588

Last Updated: 2024-01-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-01
• Study Completion Date: 2025-12-31

Brief 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.

Detailed 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.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Controlled combined program (aerobic-resistant)

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).

Group Type: EXPERIMENTAL

Controlled combined exercise group

Intervention Type: PROCEDURE

Patients will undergo protocol-defined combined aerobic-resistant therapy on a cycling ergometer and multifunctional fitness device

Conventional rehabilitation

Patients randomized into this study arm will undergo conventional rehabilitation.

Group Type: ACTIVE_COMPARATOR

Conventional rehabilitation

Intervention Type: PROCEDURE

Patients will undergo conventional rehabilitation.

No intervention

Patients randomized into this study arm will undergo no intervention and will serve as the control group.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Controlled combined exercise group

Patients will undergo protocol-defined combined aerobic-resistant therapy on a cycling ergometer and multifunctional fitness device

Intervention Type: PROCEDURE

Conventional rehabilitation

Patients will undergo conventional rehabilitation.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Ostrava

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anna Šilarová, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Ostrava

Locations

University Hospital Ostrava

Ostrava, Moravian-Silesian Region, Czechia

Site Status: RECRUITING

Countries

Czechia

Central Contacts

Jiří Hynčica

Role: CONTACT

jiri.hyncica@fno.cz

0042059737 ext. 2587

Facility Contacts

Jiří Hynčica

Role: primary

jiri.hyncica@fno.cz

0042059737 ext. 2587

References

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.

Reference Type: BACKGROUND

PMID: 32169035 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33901439 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25634170 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24603938 (View on PubMed)

Other Identifiers

01/RVO-FNOs/2022

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

01/RVO-FNOs/2022

Identifier Type: -

Identifier Source: org_study_id