- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07833020
Gyrotonic Exercise in Lupus Adolescents Who Survived From Intensive Care
lupus adoelscented who recently survive from intenive care unit usually complain postintenive care unit syndrome in addition to stress, fatigue, low life quality, depression, low physical performance, low grip strenght, insomnia, weak cariorepsiratory fitness, and low physical capcity. gryotonic exercise may improve these problems
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
forty lupus adoelscented who recently survive from intenive care unit will be divided to 8-week gryotonic exercise group (20 patients) and waitlist group who contained the same number (20 patients)
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Ali MA Ismail, PhD
- Telefonnummer: +201005154209
- E-mail: ali.mohamed@pt.cu.edu.eg
Undersøgelse Kontakt Backup
- Navn: Fatma M mohamed, PhD
- Telefonnummer: +201033321109
- E-mail: fatmaraed1994@gmail.com
Studiesteder
-
-
Giza Governorate
-
Dokki, Giza Governorate, Egypten, 11432
- Rekruttering
- Cairo University
-
Kontakt:
- ali AM Ismail, lecturer
- Telefonnummer: +201005154209
- E-mail: ali.mohamed@pt.cu.edu.eg
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- childhood-onset lupus
- adolescents who survived from intensive care unit
- adlescents who are in risk of developing pos-tintenive care-unit syndrome (i.e patients who admitted to an intenive care unit for at least four days in last year)
Exclusion Criteria:
- mental diseases
- upper or lower limb fractures
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: group I
twenty lupus adoelscented who recently survive from intenive care unit will be perform 8-week gryotonic exercise |
twenty lupus adoelscented who recently survive from intenive care unit will be perform 8-week gryotonic exercise |
|
Ingen indgriben: group II
twenty lupus adoelscented who recently survive from intenive care unit will be act as waitlist group for 8 weeks |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
total score of post-intensive care-syndrome questioanire-related subscales
Tidsramme: it will be assessed after 8 weeks
|
the total score post-intensive care-syndrome questionaire-related subscales (cognitive, physical, and mental) will be assessed |
it will be assessed after 8 weeks
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
patient health questionnaire
Tidsramme: it will be assessed after 8 weeks
|
it is a questionnaire for depression assessment |
it will be assessed after 8 weeks
|
|
stress vuilnerability scale
Tidsramme: it will be assessed after 8 weeks
|
it is a questionaire assesing stress level |
it will be assessed after 8 weeks
|
|
physical score of child health questionaire
Tidsramme: it will be assessed after 8 weeks
|
the parent form of this queationaire will assess physical summary level of participants |
it will be assessed after 8 weeks
|
|
Child health questionaire -mental summary
Tidsramme: it will be assessed after 8 weeks
|
the parent form of this queationaire will assess mental summary level of participants |
it will be assessed after 8 weeks
|
|
lupus-related life quality (physical health domain)
Tidsramme: it will be assessed after 8 weeks
|
A questionaire will assess lupus-related physical health |
it will be assessed after 8 weeks
|
|
lupus-related life quality (fatigue domain)
Tidsramme: it will be assessed after 8 weeks
|
a questionaire that will assess lupus-related fatigue |
it will be assessed after 8 weeks
|
|
Pitsburrg sleeping quality index
Tidsramme: it will be assessed after 8 weeks
|
the total score of this questionaire that measures sleep quality will be evalauted |
it will be assessed after 8 weeks
|
|
six minute walk distance
Tidsramme: it wil be assessed after 8 weeks
|
it will assess physcial capacity |
it wil be assessed after 8 weeks
|
|
Ruffier index
Tidsramme: it will be assessed after 8 weeks
|
it is and index that will measure cardiorespiratory fittness |
it will be assessed after 8 weeks
|
|
grip stenght
Tidsramme: it will be assessed after 8 weeks
|
it will be assessed for dominant hand |
it will be assessed after 8 weeks
|
|
Short Physical Performance Battery
Tidsramme: It will be assessed after 8 weeks
|
it is assessment for phsyical performance of patients |
It will be assessed after 8 weeks
|
|
mental subscale of post-intensive care-syndrome questioanire
Tidsramme: It will be measured after 8 weeks
|
the mental subscale of post-intensive care-syndrome questionaire will be assessed |
It will be measured after 8 weeks
|
|
cognitive subscale of post-intensive care-syndrome questioanire
Tidsramme: It will be measured after 8 weeks
|
the cogniitve subscale of post-intensive care-syndrome questionaire will be assessed |
It will be measured after 8 weeks
|
|
Physcial subscale of post-intensive care-syndrome questionaire
Tidsramme: It will be measured after 8 weeks
|
the physical subscale of post-intensive care-syndrome questionaire will be assessed |
It will be measured after 8 weeks
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Ali MA Ismail, lecturer, Department of Physical Therapy for Cardiovascular/Respiratory Disorder and Geriatrics
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- IRB000-14233-100
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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Studerer et amerikansk FDA-reguleret enhedsprodukt
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