Clinical trial NCT05671588: Cardiovascular Fitness of Patients With Multiple Sclerosis, Effect of Exercise on Fatigue and Depression
Official title: Cardiovascular Fitness and the Influence of a Controlled Combined Exercise Program on Fatigue and Depression of Newly Diagnosed Patients With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
Controlled combined exercise
Cardiovascular fitness
Fatigue
Depression
Lead sponsor: University Hospital Ostrava
Sponsor class: OTHER
First posted: 2023-01-04
Enrollment: 70
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study subjects will be enrolled into two parallel groups.
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Maximal aerobic capacity (VO2max.kg-1)
timeFrame: 6 months
measure: Power to weight ratio (W.kg-1)
timeFrame: 6 months
Secondary outcomes:
measure: Modified Fatigue Impact Scale (MFIS)
timeFrame: 6 months
measure: Symptom-Checklist-90-Standard (SCL-90-S)
timeFrame: 6 months
measure: Beck Depression Inventory Score II (BDI II)
timeFrame: 6 months
measure: 36-Item Short Form Survey (SF-36)
timeFrame: 6 months
measure: Maximal heart rate (bpm)
timeFrame: 6 months
measure: Heart rate variability (ms)
timeFrame: 6 months
measure: Body composition analysis %)
timeFrame: 6 months
Other outcomes:
measure: Cost-benefit analysis of early rehabilitation intervention (CZK)
timeFrame: 6 months
Locations:
city: Ostrava
country: Czechia
facility: University Hospital Ostrava
state: Moravian-Silesian Region
Study officials:
affiliation: University Hospital Ostrava
name: Anna Šilarová, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.