Clinical trial NCT04667130: Preventive Program in Multiple Sclerosis
Official title: Preventive Complex Program for Newly Diagnosed People With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Preventive program
Multiple Sclerosis
Rehabilitation
Lead sponsor: Charles University, Czech Republic
Sponsor class: OTHER
First posted: 2020-12-14
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study monitor the immediate and persistent impact of a preventive complex six-month program specifically developed for newly diagnosed people with multiple sclerosis on fatigue, mental and physical fitness, and quality of life. The study determined whether changes in clinical function are related to changes in neurohormones, and whether the effect of therapy is dependent on the active approach of study participants.

Detailed description: The patients who were newly diagnosed with MS underwent a six-month preventive comprehensive program, which included individual physiotherapy focused on the treatment of functional disorders of the loco-motor system and therapy on a neurophysiological basis, group psychotherapy and controlled aerobic training. The participants were examined three times - before the start of the physiotherapy program, immediately after its completion and six months apart. Influence on physical fitness (spiroergometric examination), fatigue (Modify Fatigue Impact Scale, fatigue scale for motor and cognitive functions), depression (Beck scale for evaluation of depression), admission of disease RS (Inventory of admission of multiple sclerosis, quality of life) life and selected neurohormones (dehydroepiandrosterone-DHEA, dehydroepiandrosterone sulphate - DHEAS, cortisol).

Eligibility criteria: Inclusion Criteria:

* definite MS
* stable clinical status in the preceding 3 months
* imumnomodulatory treatment for at least two years (including glatiramer acetate, interferon beta-1a, 1b, mitoxantrone, fingolimod, natalizumab)
* Expanded Disability Status Scale (EDSS)≤6
* predominant motor impartment
* six months or more without any physiotherapy
* ability to undergo ambulatory physiotherapy

Exclusion Criteria:

* other neurological disease or conditions disabling movement

Primary outcomes:
measure: Questionnaires - The Fatigue scale for motor and cognitive functions
timeFrame: change after six months of the program and after next six moths without therapy is being assessed
measure: Questionnaires - The Satisfaction With Life Scale
timeFrame: change after six months of the program and after next six moths without therapy is being assessed
measure: Questionnaires - Multiple Sclerosis Acceptance Questionnaire
timeFrame: change after six months of the program and after next six moths without therapy is being assessed
measure: Questionnaires - Beck Depression Inventory Score
timeFrame: change after six months of the program and after next six moths without therapy is being assessed
Secondary outcomes:
measure: Ventilation capacity
timeFrame: change after six months of the program and after next six moths without therapy is being assessed
measure: Metabolic utilization
timeFrame: change after six months of the program and after next six moths without therapy is being assessed
measure: Maximal oxygen uptake
timeFrame: change after six months of the program and after next six moths without therapy is being assessed
measure: Maximal oxygen pulse
timeFrame: change after six months of the program and after next six moths without therapy is being assessed
measure: Relative ventilation
timeFrame: change after six months of the program and after next six moths without therapy is being assessed
measure: Cortisol
timeFrame: change after six months of the program and after next six moths without therapy is being assessed
measure: Cortizone
timeFrame: change after six months of the program and after next six moths without therapy is being assessed
measure: Dehydroepiandrosterone (DHEA)
timeFrame: change after six months of the program and after next six moths without therapy is being assessed
measure: 7β-hydroxydehydroepiandrosterone (7β-OH-DHEA )
timeFrame: change after six months of the program and after next six moths without therapy is being assessed
measure: 7-oxo dehydroepiandrosterone (7-oxo-DHEA )
timeFrame: change after six months of the program and after next six moths without therapy is being assessed
Other outcomes:
measure: Questionnaires - Modified Fatigue Impact Scale
timeFrame: change after six months of the program and after next six moths without therapy is being assessed
Locations:
city: Praha
country: Czechia
facility: Kamila Řasová
Study officials:
affiliation: Third Faculty of Medicine Charles University
name: Kamila Řasová, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: