- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT04667130
Preventive Program in Multiple Sclerosis
27 stycznia 2021 zaktualizowane przez: 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.
Przegląd badań
Status
Zakończony
Warunki
Interwencja / Leczenie
Szczegółowy opis
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 studiów
Interwencyjne
Zapisy (Rzeczywisty)
17
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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Praha, Czechy, 128 00
- Kamila Řasová
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
18 lat do 70 lat (Dorosły, Starszy dorosły)
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Wszystko
Opis
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
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Zapobieganie
- Przydział: Nie dotyczy
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
---|---|
Eksperymentalny: 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 mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
Questionnaires - The Fatigue scale for motor and cognitive functions
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
Ventilation capacity
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: change after six months of the program and after next six moths without therapy is being assessed
|
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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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 )
Ramy czasowe: 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 )
Ramy czasowe: 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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Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
Questionnaires - Modified Fatigue Impact Scale
Ramy czasowe: 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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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Śledczy
- Główny śledczy: Kamila Řasová, Ph.D., Third Faculty of Medicine Charles University
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
1 października 2017
Zakończenie podstawowe (Rzeczywisty)
1 października 2019
Ukończenie studiów (Rzeczywisty)
1 października 2019
Daty rejestracji na studia
Pierwszy przesłany
20 listopada 2020
Pierwszy przesłany, który spełnia kryteria kontroli jakości
9 grudnia 2020
Pierwszy wysłany (Rzeczywisty)
14 grudnia 2020
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
1 lutego 2021
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
27 stycznia 2021
Ostatnia weryfikacja
1 stycznia 2021
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- EK-VP/25/0/2014
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .
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