End Stage Renal DiseaseNCT06861816
Ventilatory Functions and Physical Intolerance in ESRD Adolescents: Response to Program of Walking With Dogs
A study testing incentive spirometer and walking with dog and training by incentive spirometer only in people with End Stage Renal Disease and Hemolysis, run by Cairo University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- End Stage Renal Disease, Hemolysis
- What is being tested?
- incentive spirometer and walking with dog and training by incentive spirometer only
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Feb 2025to 5 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- adolescents (forty) with ESRD
- patents on regular hemodiaysis
Who cannot join
- cardiac insult
- respiratory insult
- orthopedic problem
- liver insult
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
faculty of physical therapy Cairo university
Dokki, Giza Governorate, 11432
Ali MA Ismail, lecturer, +201005154209, ali.mohamed@pt.cu.edu.eg
shymaa bondok, lecturer, 0201223749627, dr.shaimaa.bondok@dtu.edu.eg
About this study
Official title: 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
Read the 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.
- Conditions
- End Stage Renal Disease, Hemolysis
- Being tested
- incentive spirometer and walking with dog, training by incentive spirometer only
- Medical subject headings
- Kidney Failure, Chronic, Hemolysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
incentive spirometer and walking with dogOther
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.
training by incentive spirometer onlyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| group number 1 | Experimental | 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. Receives: Other: incentive spirometer and walking with dog |
| group number 2 | Active comparator | 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. Receives: Other: training by incentive spirometer only |
What is being measured
The primary outcome is the main question the study is designed to answer.
six minute walk testing
it is a physical capacity measure
Measured: it will be measured after 12 weeks
Secondary outcomes (6)
forced vital capacity
it is a pulmonary function test
Measured: it will be measured after 12 weeks
forced expiratory volume at first second
it is a pulmonary function test
Measured: it will be measured after 12 weeks
maximal inspiratory pressure
it is a test measures strength of inspiratory muscles
Measured: it will be measured after 12 weeks
child health questionnaire (physical summary)
the parent form (50 questions) will used to measure quality of life
Measured: it will be measured after 12 weeks
child health questionnaire (mental summary)
the parent form (50 questions) will used to measure quality of life
Measured: it will be measured after 12 weeks
fatigue symptoms inventory
it is a questionnaire assesses fatigue
Measured: it will be measured after 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study start5 Feb 2025
- Primary completion1 Jun 2025 (estimated)
- Study completion5 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Mohamed Ali ismail, Cairo University
- Investigators
- Ali MA Ismail, lecturer, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06861816
- Sponsor's protocol ID
- IRB00014233-25
- Status last verified
- Mar 2025
- First submitted
- 3 Mar 2025
- Last updated
- 6 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fatigue, Ventilatory Functions, Physical Intolerance, and Life Quality in ESRD Adolescents: Response to Program of Walking With Dogs
- ClinicalTrials.gov ID
- NCT06861816
- Acronym / sponsor ID
- IRB00014233-25
- Conditions
- End Stage Renal Disease, Hemolysis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 5 Feb 2025 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 5 Jun 2025 (estimated)
- First posted
- 6 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group number 1 | Experimental | Other: incentive spirometer and walking with dogEnd 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. |
| group number 2 | Active comparator | Other: training by incentive spirometer onlyEnd stage renal diseased adolescents (numbering twenty) will trained by incentive spirometer 30 min during the sessions of dialysis three applications weekly for 12 weeks. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- adolescents (forty) with ESRD
- patents on regular hemodiaysis
Key exclusion criteria (4 listed)
- cardiac insult
- respiratory insult
- orthopedic problem
- liver insult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| incentive spirometer and walking with dogEnd 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. | Other | group number 1 |
| training by incentive spirometer onlyEnd stage renal diseased adolescents (numbering twenty) will trained by incentive spirometer 30 min during the sessions of dialysis three applications weekly for 12 weeks. | Other | group number 2 |
Primary outcome
six minute walk testing
Time frame: it will be measured after 12 weeks
it is a physical capacity measure
6 secondary outcomes
forced vital capacity
Time frame: it will be measured after 12 weeks
forced expiratory volume at first second
Time frame: it will be measured after 12 weeks
maximal inspiratory pressure
Time frame: it will be measured after 12 weeks
child health questionnaire (physical summary)
Time frame: it will be measured after 12 weeks
child health questionnaire (mental summary)
Time frame: it will be measured after 12 weeks
fatigue symptoms inventory
Time frame: it will be measured after 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ali MA Ismail, lecturer principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing incentive spirometer and walking with dog and training by incentive spirometer only in people with End Stage Renal Disease and Hemolysis, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ali MA Ismail, lecturer (01005154209, ali.mohamed@pt.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
six minute walk testing (time frame: it will be measured after 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2025.