- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06861816
Ventilatory Functions and Physical Intolerance in ESRD Adolescents: Response to Program of Walking With Dogs
March 3, 2025 updated by: Ali Mohamed Ali ismail, Cairo University
Fatigue, Ventilatory Functions, Physical Intolerance, and Life Quality in ESRD Adolescents: Response to Program of Walking With Dogs
adolescents with chronic renal failure going on hemodialysis usually complain many problems including compromised ventilation, early fatigue, early physical intolerance, and bad life quality.
incentive spirometer is highly recommended to improve these problems.
also, walking program, especially walking with dog, can increase the benefits of incentive spirometer
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
End stage renal diseased adolescents (numbering forty) will be grouped randomly to two random groups, twenty adolescents in group I or group II.
Both groups will trained by incentive spirometer 30 min during the sessions of dialysis three applications weekly for 12 weeks.
Group I will additionally walked freely with a dog 30 min three times weekly (in opposite days of hemodialysis).
The duration of this trial will be 12 weeks.
Study Type
Interventional
Enrollment (Estimated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ali MA Ismail, lecturer
- Phone Number: 01005154209
- Email: ali.mohamed@pt.cu.edu.eg
Study Contact Backup
- Name: shymaa bondok, lecturer
- Phone Number: 0201223749627
- Email: dr.shaimaa.bondok@dtu.edu.eg
Study Locations
-
-
Giza
-
Dokki, Giza, Egypt, 11432
- Recruiting
- Faculty of Physical Therapy Cairo University
-
Contact:
- Ali MA Ismail, lecturer
- Phone Number: +201005154209
- Email: ali.mohamed@pt.cu.edu.eg
-
Contact:
- shymaa bondok, lecturer
- Phone Number: 0201223749627
- Email: dr.shaimaa.bondok@dtu.edu.eg
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- adolescents (forty) with ESRD
- patents on regular hemodiaysis
Exclusion Criteria:
- cardiac insult
- respiratory insult
- orthopedic problem
- liver insult
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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 number 1
End stage renal diseased adolescents (numbering twenty) will trained by incentive spirometer 30 min during the sessions of dialysis three applications weekly for 12 weeks.
they will additionally walked freely with a dog 30 min three times weekly (in opposite days of hemodialysis).
The duration of this trial will be 12 weeks.
|
End stage renal diseased adolescents (numbering twenty) will trained by incentive spirometer 30 min during the sessions of dialysis three applications weekly for 12 weeks.
they will additionally walked freely with a dog 30 min three times weekly (in opposite days of hemodialysis).
The duration of this trial will be 12 weeks.
|
|
Active Comparator: group number 2
End stage renal diseased adolescents (numbering twenty) will trained by incentive spirometer 30 min during the sessions of dialysis three applications weekly for 12 weeks.
|
End stage renal diseased adolescents (numbering twenty) will trained by incentive spirometer 30 min during the sessions of dialysis three applications weekly for 12 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
six minute walk testing
Time Frame: it will be measured after 12 weeks
|
it is a physical capacity measure
|
it will be measured after 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
forced vital capacity
Time Frame: it will be measured after 12 weeks
|
it is a pulmonary function test
|
it will be measured after 12 weeks
|
|
forced expiratory volume at first second
Time Frame: it will be measured after 12 weeks
|
it is a pulmonary function test
|
it will be measured after 12 weeks
|
|
maximal inspiratory pressure
Time Frame: it will be measured after 12 weeks
|
it is a test measures strength of inspiratory muscles
|
it will be measured after 12 weeks
|
|
child health questionnaire (physical summary)
Time Frame: it will be measured after 12 weeks
|
the parent form (50 questions) will used to measure quality of life
|
it will be measured after 12 weeks
|
|
child health questionnaire (mental summary)
Time Frame: it will be measured after 12 weeks
|
the parent form (50 questions) will used to measure quality of life
|
it will be measured after 12 weeks
|
|
fatigue symptoms inventory
Time Frame: it will be measured after 12 weeks
|
it is a questionnaire assesses fatigue
|
it will be measured after 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ali MA Ismail, lecturer, Cairo University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 5, 2025
Primary Completion (Estimated)
June 1, 2025
Study Completion (Estimated)
June 5, 2025
Study Registration Dates
First Submitted
March 3, 2025
First Submitted That Met QC Criteria
March 3, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
March 3, 2025
Last Verified
March 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00014233-25
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
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