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

January 12, 2024 updated by: University Hospital Ostrava

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Czechia
    • Moravian-Silesian Region
      • Ostrava, Moravian-Silesian Region, Czechia, 708 52
        • Recruiting
        • University Hospital Ostrava
        • Contact:
        • Principal Investigator:
          • Anna Šilarová, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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).
Procedure: Controlled combined exercise group
Patients will undergo protocol-defined combined aerobic-resistant therapy on a cycling ergometer and multifunctional fitness device
Active Comparator: Conventional rehabilitation
Patients randomized into this study arm will undergo conventional rehabilitation.
Procedure: Conventional rehabilitation
Patients will undergo conventional rehabilitation.
No Intervention: No intervention
Patients randomized into this study arm will undergo no intervention and will serve as the control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximal aerobic capacity (VO2max.kg-1)
Time Frame: 6 months
Change after six months follow up in conventional, experimental and control group
6 months
Power to weight ratio (W.kg-1)
Time Frame: 6 months
Change after six months follow up in conventional, experimental and control group
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified Fatigue Impact Scale (MFIS)
Time Frame: 6 months
Self-reported measure of level of fatigue, minimum 0 points, maximum 84 points - the less score means less fatigue
6 months
Symptom-Checklist-90-Standard (SCL-90-S)
Time Frame: 6 months
Change in result of percentile score
6 months
Beck Depression Inventory Score II (BDI II)
Time Frame: 6 months
Self-reported rating inventory that measures characteristic attitudes and symptoms of depression, 0-13 - minimal or none depression, 29-63 - severe depression
6 months
36-Item Short Form Survey (SF-36)
Time Frame: 6 months
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
Maximal heart rate (bpm)
Time Frame: 6 months
Change after six months follow up in conventional, experimental and control group
6 months
Heart rate variability (ms)
Time Frame: 6 months
Change after six months follow up in conventional, experimental and control group
6 months
Body composition analysis %)
Time Frame: 6 months
Body composition (fat, water, muscle, bone mass) analysis will be performed in study subjects and expressed as per cent.
6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cost-benefit analysis of early rehabilitation intervention (CZK)
Time Frame: 6 months
Cost-benefit analysis of early rehabilitation intervention will be performed and expressed as the price in Czech crowns (CZK).
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Ostrava

Investigators

  • Principal Investigator: Anna Šilarová, MD, University Hospital Ostrava

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2022

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

December 12, 2022

First Submitted That Met QC Criteria

January 3, 2023

First Posted (Actual)

January 4, 2023

Study Record Updates

Last Update Posted (Actual)

January 16, 2024

Last Update Submitted That Met QC Criteria

January 12, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01/RVO-FNOs/2022 (Other Grant/Funding Number: University Hospital Ostrava)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to make individual participant data available to other researchers. The data may be provided upon request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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