Preventive Program in Multiple Sclerosis
27. ledna 2021 aktualizováno: Kamila Řasová
Preventive Complex Program for Newly Diagnosed People With Multiple Sclerosis
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.
Přehled studie
Postavení
Dokončeno
Podmínky
Detailní popis
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).
Typ studie
Intervenční
Zápis (Aktuální)
17
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Praha, Česko, 128 00
- Kamila Řasová
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let až 70 let (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: Preventive Complex Program for Newly Diagnosed People With Multiple Sclerosis
Providing information about the possibilities of physiotherapy, Computer Kinesiology, psychotherapy, Motor progam activating therapy, aerobic exercise
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Preventive program included informations of the possibilities of physiotherapy in the treatment of multiple sclerosis focused on fatigue management - recommending lifestyle changes.
Program included a the treatment of psychosomatic, viscerosomatic functional disorders by reflexively poor connection through the locomotor system using computer kinesiology, psychotherapy, manual therapy - where patients are corrected into a postural position and the joints are functionally centred, and aerobic exercise to influence fatigue and improve the performance of the cardiovascular system.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Questionnaires - The Fatigue scale for motor and cognitive functions
Časové okno: change after six months of the program and after next six moths without therapy is being assessed
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FSMC - is an assessment of MS-related cognitive and motor fatigue.
A Likert-type 5-point scale (ranging from 'does not apply at all' to 'applies completely') produces a score between 1 and 5 for each scored question.
Thus minimum value is 20 (no fatigue at all) and maximum value is 100 (severest grade of fatigue).
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change after six months of the program and after next six moths without therapy is being assessed
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Questionnaires - The Satisfaction With Life Scale
Časové okno: change after six months of the program and after next six moths without therapy is being assessed
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The scale measures the current level of satisfaction with one's own life.
Investigators express the extent to which they agree or disagree with the five statements.
The rating scale contains 7 points (1- "strongly disagree" and 7 - "strongly agree").
The maximum number of points on the scale is 35 (maximum satisfaction with your life) and the minimum number of points is 5 (dissatisfaction with your life).
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change after six months of the program and after next six moths without therapy is being assessed
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Questionnaires - Multiple Sclerosis Acceptance Questionnaire
Časové okno: change after six months of the program and after next six moths without therapy is being assessed
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This questionnaire consists of 20 statements that relate to the lives of patients with MS.
The rating scale has seven points (1- "never pays" to 7 - "always pays").
The minimum value is 20 (minimum adaptation to the diagnosis of MS for a large limitation of the normal life of MS) and the maximum value is 140 points (maximum adaptation to the diagnosis of MS - without the limitation of the normal life of MS) .
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change after six months of the program and after next six moths without therapy is being assessed
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Questionnaires - Beck Depression Inventory Score
Časové okno: change after six months of the program and after next six moths without therapy is being assessed
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questionnaire is divided into thirteen categories and patients select a statement in each category which best fits their current feelings on the scale ranged from 0 (the best feelings) to 3 (the worst feelings).
The maximum value of the total scale is 39 and shows the worst feeling of the person.
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change after six months of the program and after next six moths without therapy is being assessed
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Ventilation capacity
Časové okno: change after six months of the program and after next six moths without therapy is being assessed
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Forced vital capacity = FVC [ l ]
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change after six months of the program and after next six moths without therapy is being assessed
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Metabolic utilization
Časové okno: change after six months of the program and after next six moths without therapy is being assessed
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maximal muscle performance = Rmax [ Watt kg-1 ]
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change after six months of the program and after next six moths without therapy is being assessed
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Maximal oxygen uptake
Časové okno: change after six months of the program and after next six moths without therapy is being assessed
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VO2 kg-1 [ VO2max.kg-1 ]
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change after six months of the program and after next six moths without therapy is being assessed
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Maximal oxygen pulse
Časové okno: change after six months of the program and after next six moths without therapy is being assessed
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VO2 HR-1 kg-1 [ VO2max.TF-1 ]
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change after six months of the program and after next six moths without therapy is being assessed
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Relative ventilation
Časové okno: change after six months of the program and after next six moths without therapy is being assessed
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[ VEmax.kg-1 ]
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change after six months of the program and after next six moths without therapy is being assessed
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Cortisol
Časové okno: change after six months of the program and after next six moths without therapy is being assessed
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levels of cortisol [ ng/mL ]
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change after six months of the program and after next six moths without therapy is being assessed
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Cortizone
Časové okno: change after six months of the program and after next six moths without therapy is being assessed
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levels of cortisone[ ng/mL ]
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change after six months of the program and after next six moths without therapy is being assessed
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Dehydroepiandrosterone (DHEA)
Časové okno: change after six months of the program and after next six moths without therapy is being assessed
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levels of DHEA [ ng/mL ]
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change after six months of the program and after next six moths without therapy is being assessed
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7β-hydroxydehydroepiandrosterone (7β-OH-DHEA )
Časové okno: change after six months of the program and after next six moths without therapy is being assessed
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levels of 7β-OH-DHEA [ ng/mL ]
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change after six months of the program and after next six moths without therapy is being assessed
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7-oxo dehydroepiandrosterone (7-oxo-DHEA )
Časové okno: change after six months of the program and after next six moths without therapy is being assessed
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levels of 7-oxo-DHEA [ ng/mL ]
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change after six months of the program and after next six moths without therapy is being assessed
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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Questionnaires - Modified Fatigue Impact Scale
Časové okno: change after six months of the program and after next six moths without therapy is being assessed
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This scale consists of 21 statements that describe how often fatigue has affected a person during last four weeks.
Each statement is ranged from 0 (never) to 4 (almost, always).
The maximum value of the scale is 84.
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change after six months of the program and after next six moths without therapy is being assessed
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Kamila Řasová, Ph.D., Third Faculty of Medicine Charles University
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
1. října 2017
Primární dokončení (Aktuální)
1. října 2019
Dokončení studie (Aktuální)
1. října 2019
Termíny zápisu do studia
První předloženo
20. listopadu 2020
První předloženo, které splnilo kritéria kontroly kvality
9. prosince 2020
První zveřejněno (Aktuální)
14. prosince 2020
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
1. února 2021
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
27. ledna 2021
Naposledy ověřeno
1. ledna 2021
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- EK-VP/25/0/2014
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