- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT04667130
Preventive Program in Multiple Sclerosis
27 januari 2021 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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).
Studietyp
Interventionell
Inskrivning (Faktisk)
17
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
-
Praha, Tjeckien, 128 00
- Kamila Řasová
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 70 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: 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
|
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Questionnaires - The Fatigue scale for motor and cognitive functions
Tidsram: change after six months of the program and after next six moths without therapy is being assessed
|
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).
|
change after six months of the program and after next six moths without therapy is being assessed
|
Questionnaires - The Satisfaction With Life Scale
Tidsram: change after six months of the program and after next six moths without therapy is being assessed
|
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).
|
change after six months of the program and after next six moths without therapy is being assessed
|
Questionnaires - Multiple Sclerosis Acceptance Questionnaire
Tidsram: change after six months of the program and after next six moths without therapy is being assessed
|
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) .
|
change after six months of the program and after next six moths without therapy is being assessed
|
Questionnaires - Beck Depression Inventory Score
Tidsram: change after six months of the program and after next six moths without therapy is being assessed
|
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.
|
change after six months of the program and after next six moths without therapy is being assessed
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Ventilation capacity
Tidsram: change after six months of the program and after next six moths without therapy is being assessed
|
Forced vital capacity = FVC [ l ]
|
change after six months of the program and after next six moths without therapy is being assessed
|
Metabolic utilization
Tidsram: change after six months of the program and after next six moths without therapy is being assessed
|
maximal muscle performance = Rmax [ Watt kg-1 ]
|
change after six months of the program and after next six moths without therapy is being assessed
|
Maximal oxygen uptake
Tidsram: change after six months of the program and after next six moths without therapy is being assessed
|
VO2 kg-1 [ VO2max.kg-1 ]
|
change after six months of the program and after next six moths without therapy is being assessed
|
Maximal oxygen pulse
Tidsram: 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 ]
|
change after six months of the program and after next six moths without therapy is being assessed
|
Relative ventilation
Tidsram: change after six months of the program and after next six moths without therapy is being assessed
|
[ VEmax.kg-1 ]
|
change after six months of the program and after next six moths without therapy is being assessed
|
Cortisol
Tidsram: change after six months of the program and after next six moths without therapy is being assessed
|
levels of cortisol [ ng/mL ]
|
change after six months of the program and after next six moths without therapy is being assessed
|
Cortizone
Tidsram: change after six months of the program and after next six moths without therapy is being assessed
|
levels of cortisone[ ng/mL ]
|
change after six months of the program and after next six moths without therapy is being assessed
|
Dehydroepiandrosterone (DHEA)
Tidsram: change after six months of the program and after next six moths without therapy is being assessed
|
levels of DHEA [ ng/mL ]
|
change after six months of the program and after next six moths without therapy is being assessed
|
7β-hydroxydehydroepiandrosterone (7β-OH-DHEA )
Tidsram: change after six months of the program and after next six moths without therapy is being assessed
|
levels of 7β-OH-DHEA [ ng/mL ]
|
change after six months of the program and after next six moths without therapy is being assessed
|
7-oxo dehydroepiandrosterone (7-oxo-DHEA )
Tidsram: change after six months of the program and after next six moths without therapy is being assessed
|
levels of 7-oxo-DHEA [ ng/mL ]
|
change after six months of the program and after next six moths without therapy is being assessed
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Questionnaires - Modified Fatigue Impact Scale
Tidsram: change after six months of the program and after next six moths without therapy is being assessed
|
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.
|
change after six months of the program and after next six moths without therapy is being assessed
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Kamila Řasová, Ph.D., Third Faculty of Medicine Charles University
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 oktober 2017
Primärt slutförande (Faktisk)
1 oktober 2019
Avslutad studie (Faktisk)
1 oktober 2019
Studieregistreringsdatum
Först inskickad
20 november 2020
Först inskickad som uppfyllde QC-kriterierna
9 december 2020
Första postat (Faktisk)
14 december 2020
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
1 februari 2021
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
27 januari 2021
Senast verifierad
1 januari 2021
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- EK-VP/25/0/2014
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på Multipel skleros
-
Centre Hospitalier Universitaire de NīmesAvslutadMonckeberg Medial Calcific SclerosisFrankrike
-
Assistance Publique - Hôpitaux de ParisOkändArteriosclerosis Obliterans | Diabetiska vaskulära sjukdomar | Monckeberg Medial Calcific SclerosisFrankrike
-
City of Hope Medical CenterNational Cancer Institute (NCI)Aktiv, inte rekryterandeKlassiskt Hodgkin lymfom | Lymfocytrikt klassiskt Hodgkin-lymfom | Ann Arbor stadium IB Hodgkin lymfom | Ann Arbor stadium II Hodgkin lymfom | Ann Arbor stadium IIA Hodgkin lymfom | Ann Arbor stadium IIB Hodgkin lymfom | Ann Arbor stadium I Hodgkin lymfom | Ann Arbor Steg I blandad cellularitet Klassiskt... och andra villkorFörenta staterna