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

University Hospital Ostrava

Status: Enrolling

Conditions: Multiple Sclerosis

Treatments: Procedure: Conventional rehabilitation; Procedure: Controlled combined exercise group

Study type: Interventional

Funder types: Other

Identifiers

NCT05671588

01/RVO-FNOs/2022 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 estimated patients

Sex: All

Ages: 20 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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70 participants in 3 patient groups

Controlled combined program (aerobic-resistant)

Experimental group

Description:

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).

Treatment:

Procedure: Controlled combined exercise group

Conventional rehabilitation

Active Comparator group

Description:

Patients randomized into this study arm will undergo conventional rehabilitation.

Treatment:

Procedure: Conventional rehabilitation

No intervention

No Intervention group

Description:

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