Preventive Program in Multiple Sclerosis
27. januar 2021 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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).
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
17
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Praha, Tjekkiet, 128 00
- Kamila Řasová
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 70 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: 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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Questionnaires - The Fatigue scale for motor and cognitive functions
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Ventilation capacity
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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 )
Tidsramme: 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 )
Tidsramme: 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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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Questionnaires - Modified Fatigue Impact Scale
Tidsramme: 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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Kamila Řasová, Ph.D., Third Faculty of Medicine Charles University
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. oktober 2017
Primær færdiggørelse (Faktiske)
1. oktober 2019
Studieafslutning (Faktiske)
1. oktober 2019
Datoer for studieregistrering
Først indsendt
20. november 2020
Først indsendt, der opfyldte QC-kriterier
9. december 2020
Først opslået (Faktiske)
14. december 2020
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
1. februar 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
27. januar 2021
Sidst verificeret
1. januar 2021
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- EK-VP/25/0/2014
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