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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital Ostrava

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 12, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 3, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 4, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 16, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 12, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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