NCT06861816

Brief 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. also, walking program, especially walking with dog, can increase the benefits of incentive spirometer

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 5, 2025

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

March 3, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 6, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 5, 2025

Completed
Last Updated

March 6, 2025

Status Verified

March 1, 2025

Enrollment Period

4 months

First QC Date

March 3, 2025

Last Update Submit

March 3, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • six minute walk testing

    it is a physical capacity measure

    it will be measured after 12 weeks

Secondary Outcomes (6)

  • forced vital capacity

    it will be measured after 12 weeks

  • forced expiratory volume at first second

    it will be measured after 12 weeks

  • maximal inspiratory pressure

    it will be measured after 12 weeks

  • child health questionnaire (physical summary)

    it will be measured after 12 weeks

  • child health questionnaire (mental summary)

    it will be measured after 12 weeks

  • +1 more secondary outcomes

Study Arms (2)

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.

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.

Other: training by incentive spirometer only

Interventions

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.

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.

group number 2

Eligibility Criteria

Age13 Years - 17 Years
Sexall(Gender-based eligibility)
Gender Eligibility Detailsbased on self-representation of gender identity.
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • adolescents (forty) with ESRD
  • patents on regular hemodiaysis

You may not qualify if:

  • cardiac insult
  • respiratory insult
  • orthopedic problem
  • liver insult

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

faculty of physical therapy Cairo university

Dokki, Giza Governorate, 11432, Egypt

RECRUITING

MeSH Terms

Conditions

Kidney Failure, ChronicHemolysis

Interventions

Walking

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

LocomotionMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaExerciseMotor Activity

Study Officials

  • Ali MA Ismail, lecturer

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ali MA Ismail, lecturer

CONTACT

shymaa bondok, lecturer

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of physical therapy for Cardiovascular, Respiratory disorder and Geriatrics, Faculty of Physical Therapy, Cairo University

Study Record Dates

First Submitted

March 3, 2025

First Posted

March 6, 2025

Study Start

February 5, 2025

Primary Completion

June 1, 2025

Study Completion

June 5, 2025

Last Updated

March 6, 2025

Record last verified: 2025-03

Locations