- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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)
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Ali MA Ismail, PhD
- Telefonnummer: +201005154209
- E-Mail: ali.mohamed@pt.cu.edu.eg
Studieren Sie die Kontaktsicherung
- Name: Fatma M mohamed, PhD
- Telefonnummer: +201033321109
- E-Mail: fatmaraed1994@gmail.com
Studienorte
-
-
Giza Governorate
-
Dokki, Giza Governorate, Ägypten, 11432
- Rekrutierung
- Cairo University
-
Kontakt:
- ali AM Ismail, lecturer
- Telefonnummer: +201005154209
- E-Mail: ali.mohamed@pt.cu.edu.eg
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 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 |
|
Kein Eingriff: group II
twenty lupus adoelscented who recently survive from intenive care unit will be act as waitlist group for 8 weeks |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
total score of post-intensive care-syndrome questioanire-related subscales
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
patient health questionnaire
Zeitfenster: it will be assessed after 8 weeks
|
it is a questionnaire for depression assessment |
it will be assessed after 8 weeks
|
|
stress vuilnerability scale
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: it wil be assessed after 8 weeks
|
it will assess physcial capacity |
it wil be assessed after 8 weeks
|
|
Ruffier index
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Ali MA Ismail, lecturer, Department of Physical Therapy for Cardiovascular/Respiratory Disorder and Geriatrics
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Andere Studien-ID-Nummern
- IRB000-14233-100
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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