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Multiple SclerosisNCT05671588

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

A study testing Conventional rehabilitation in people with Multiple Sclerosis, run by University Hospital Ostrava at 1 site in Czechia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 20 to 45 years
Conditions the study is for
Multiple Sclerosis
What is being tested?
Conventional rehabilitation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteCzechia
Study dates
1 May 2022to 31 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 45 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • Progressive forms of MS (PRMS or SPMS), Malignant MS
  • Non-cooperation, disagreement with the study
  • Contraindication to spiroergometry

Trial locations and contacts

1 site in 1 country.

Jiří Hynčica contact

0042059737 ext. 2587

jiri.hyncica@fno.cz

Czechia1 site, 1 recruiting

  • University Hospital Ostrava

    Ostrava, Moravian-Silesian Region, 708 52

    Jiří Hynčica, 0042059737 ext. 2587, jiri.hyncica@fno.cz

    Anna Šilarová, MD

    Recruiting

Other trials in Czechia

About this study

Official title: 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.

Read the 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.

Being tested
Controlled combined exercise group, Conventional rehabilitation
Keywords
Multiple Sclerosis, Controlled combined exercise, Cardiovascular fitness, Fatigue, Depression
Medical subject headings
Multiple Sclerosis, Fatigue, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Controlled combined exercise groupProcedure or surgery

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

  • Conventional rehabilitationProcedure or surgery

    Patients will undergo conventional rehabilitation.

Study groups in NCT05671588
Study groupRoleWhat they receive
Controlled combined program (aerobic-resistant)ExperimentalPatients 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).
Receives: Procedure: Controlled combined exercise group
Conventional rehabilitationActive comparatorPatients randomized into this study arm will undergo conventional rehabilitation.
Receives: Procedure: Conventional rehabilitation
No interventionNo interventionPatients randomized into this study arm will undergo no intervention and will serve as the control group.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximal aerobic capacity (VO2max.kg-1)

    Change after six months follow up in conventional, experimental and control group

    Measured: 6 months

  2. Power to weight ratio (W.kg-1)

    Change after six months follow up in conventional, experimental and control group

    Measured: 6 months

Secondary outcomes (7)

  1. Modified Fatigue Impact Scale (MFIS)

    Self-reported measure of level of fatigue, minimum 0 points, maximum 84 points - the less score means less fatigue

    Measured: 6 months

  2. Symptom-Checklist-90-Standard (SCL-90-S)

    Change in result of percentile score

    Measured: 6 months

  3. 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

    Measured: 6 months

  4. 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

    Measured: 6 months

  5. Maximal heart rate (bpm)

    Change after six months follow up in conventional, experimental and control group

    Measured: 6 months

  6. Heart rate variability (ms)

    Change after six months follow up in conventional, experimental and control group

    Measured: 6 months

  7. Body composition analysis %)

    Body composition (fat, water, muscle, bone mass) analysis will be performed in study subjects and expressed as per cent.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jan 2023
  2. Study start1 May 2022
  3. Primary completion30 Jun 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
The study subjects will be enrolled into two parallel groups.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05671588
Sponsor's protocol ID
01/RVO-FNOs/2022
Other IDs
01/RVO-FNOs/2022
Status last verified
Jan 2024
First submitted
12 Dec 2022
Last updated
16 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There is no plan to make individual participant data available to other researchers. The data may be provided upon request.

Publications

  • 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.

    PubMed 32169035

  • 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.

    PubMed 33901439

  • 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.

    PubMed 25634170

  • 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.

    PubMed 24603938

Questions about this trial

What is this clinical trial studying?

A study testing Conventional rehabilitation in people with Multiple Sclerosis, run by University Hospital Ostrava at 1 site in Czechia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 16 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jiří Hynčica (0042059737 ext. 2587, jiri.hyncica@fno.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximal aerobic capacity (VO2max.kg-1) (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05671588, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2024.

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