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

NCT05671588 | Unknown

• 1 other identifier: 01/RVO-FNOs/2022
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis; Controlled combined exercise; Cardiovascular fitness; Fatigue; Depression

Outcome Measures

Primary Outcomes (2)

• Maximal aerobic capacity (VO2max.kg-1)

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

  6 months

• Power to weight ratio (W.kg-1)

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

  6 months

Secondary Outcomes (7)

• Modified Fatigue Impact Scale (MFIS)

  6 months

• Symptom-Checklist-90-Standard (SCL-90-S)

  6 months

• Beck Depression Inventory Score II (BDI II)

  6 months

• 36-Item Short Form Survey (SF-36)

  6 months

• Maximal heart rate (bpm)

  6 months

Other Outcomes (1)

• Cost-benefit analysis of early rehabilitation intervention (CZK)

  6 months

Study Arms (3)

Controlled combined program (aerobic-resistant)

EXPERIMENTAL

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

Conventional rehabilitation

ACTIVE COMPARATOR

Patients randomized into this study arm will undergo conventional rehabilitation.

Procedure: Conventional rehabilitation

No intervention

NO INTERVENTION

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

Interventions

Controlled combined exercise group PROCEDURE

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

Controlled combined program (aerobic-resistant)

Conventional rehabilitation PROCEDURE

Patients will undergo conventional rehabilitation.

Conventional rehabilitation

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital Ostrava: lead

Study Sites (1)

University Hospital Ostrava

Ostrava, Moravian-Silesian Region, 708 52, Czechia

RECRUITING

Related Publications (4)

• 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.

  PMID: 32169035 BACKGROUND

• 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.

  PMID: 33901439 BACKGROUND

• 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.

  PMID: 25634170 BACKGROUND

• 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.

  PMID: 24603938 BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis; Fatigue; Depression

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Study Officials

• Anna Šilarová, MD

  University Hospital Ostrava

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiří Hynčica

CONTACT

0042059737; jiri.hyncica@fno.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: All participants of the study will undergo a clinical examination including a questionnaire survey and spiroergometry - examiners will not have access to intervention documents before and after the intervention (period of 6 months), as well as examiners will not perform the therapy.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study subjects will be enrolled into two parallel groups.

Study Record Dates

• First Submitted: December 12, 2022
• First Posted: January 4, 2023
• Study Start: May 1, 2022
• Primary Completion: June 30, 2025
• Study Completion: December 31, 2025
• Last Updated: January 16, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)