Preventive Program in Multiple Sclerosis
27. Januar 2021 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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).
Studientyp
Interventionell
Einschreibung (Tatsächlich)
17
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Praha, Tschechien, 128 00
- Kamila Řasová
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre bis 70 Jahre (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: 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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Questionnaires - The Fatigue scale for motor and cognitive functions
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Ventilation capacity
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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 )
Zeitfenster: 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 )
Zeitfenster: 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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Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Questionnaires - Modified Fatigue Impact Scale
Zeitfenster: 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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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Hauptermittler: Kamila Řasová, Ph.D., Third Faculty of Medicine Charles University
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
1. Oktober 2017
Primärer Abschluss (Tatsächlich)
1. Oktober 2019
Studienabschluss (Tatsächlich)
1. Oktober 2019
Studienanmeldedaten
Zuerst eingereicht
20. November 2020
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
9. Dezember 2020
Zuerst gepostet (Tatsächlich)
14. Dezember 2020
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
1. Februar 2021
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
27. Januar 2021
Zuletzt verifiziert
1. Januar 2021
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- EK-VP/25/0/2014
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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