- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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)
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ali MA Ismail, PhD
- Phone Number: +201005154209
- Email: ali.mohamed@pt.cu.edu.eg
Study Contact Backup
- Name: Fatma M mohamed, PhD
- Phone Number: +201033321109
- Email: fatmaraed1994@gmail.com
Study Locations
-
-
Giza Governorate
-
Dokki, Giza Governorate, Egypt, 11432
- Recruiting
- Cairo University
-
Contact:
- ali AM Ismail, lecturer
- Phone Number: +201005154209
- Email: ali.mohamed@pt.cu.edu.eg
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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 |
|
No Intervention: group II
twenty lupus adoelscented who recently survive from intenive care unit will be act as waitlist group for 8 weeks |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
total score of post-intensive care-syndrome questioanire-related subscales
Time Frame: 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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
patient health questionnaire
Time Frame: it will be assessed after 8 weeks
|
it is a questionnaire for depression assessment |
it will be assessed after 8 weeks
|
|
stress vuilnerability scale
Time Frame: 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
Time Frame: 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
Time Frame: 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)
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: it wil be assessed after 8 weeks
|
it will assess physcial capacity |
it wil be assessed after 8 weeks
|
|
Ruffier index
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ali MA Ismail, lecturer, Department of Physical Therapy for Cardiovascular/Respiratory Disorder and Geriatrics
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- IRB000-14233-100
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.