NCT05657236

Brief Summary

Despite the benefits of physical rehabilitation among adults and children with chronic illness, they avoid to engage in different physical activities especially pediatric population. Most of the children with Chronic kidney disease receive their medical treatment and follow-up with no change of their functional performance. We still lack the evidence of plyometric exercises in pediatric population with Chronic kidney disease . Therefore, the primary aim of this study is to explore the effects of strength and conditioning training in the form of plyometric exercises on balance and muscle strength in children with Chronic kidney disease .

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

December 10, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 20, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2024

Completed
Last Updated

December 20, 2022

Status Verified

December 1, 2022

Enrollment Period

1 year

First QC Date

December 10, 2022

Last Update Submit

December 10, 2022

Conditions

Keywords

Chronic Kidney Diseasesplyometric exercisesmuscle strengthbalance

Outcome Measures

Primary Outcomes (2)

  • Balance

    The Human Assessment Computer (HUMAC), a computerized dynamic posturography (commuter sports medicine, Inc., Stoughton, MA),will be used in the current study.

    after 2 months

  • muscle strength

    The Laffayette manual muscle testing (model 01163 USA) is used for objectively quantifying muscle strength including hip flexors and abductors; knee flexors and extensors

    after 2 months

Study Arms (2)

control group

OTHER
Other: medical treatment

Experimental group

EXPERIMENTAL
Other: medical treatmentOther: plyometric exercise

Interventions

traditional medical treatment and regular follow-up

Experimental groupcontrol group

Each session starts with a 5-minute warm-up of flexibility exercises (active range motion and stretching exercises).The main plyometric exercise set will be applied for 20-30 minutes and consisted of 10 exercises directed at the lower body that gradually progress by increasing the set/repetition number in two exercise blocks, each continue for 1 month .The cool down period is 5 minutes and includes walking at self-preferred speed and static stretches of the major muscle groups.

Experimental group

Eligibility Criteria

Age6 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age will be ranged from 6-10 years.
  • Both genders were included.
  • Can follow instructions.
  • Medically stable sedentary children with CKD, GFR (stage 2 (mild) eGFR of 60-89 ml/min per 1.73 m2, stage 3 (moderate) eGFR 30-59 ml/min per 1.73 m2) stage 4 (severe) eGFR of 15-29 ml/min per 1.73 m2.
  • Did not yet require renal replacement therapy (non-dialysis).

You may not qualify if:

  • Recent myocardial infarction, uncontrolled hypertension, unstable angina, symptomatic left ventricular fibrillation.
  • Severe uncontrolled diabetes,
  • Neurological or cognitive disorders
  • Peripheral vascular disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amira Mahmoud Abd-elmonem

Giza, 12662, Egypt

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Plyometric Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Amira M Mahmoud

    Cairo university, faculty of physical therapy

    PRINCIPAL INVESTIGATOR
  • Amira M Al-tohamy

    Cairo university, faculty of physical therapy

    STUDY CHAIR
  • Rasha M Helmy

    Cairo University

    STUDY DIRECTOR

Central Study Contacts

Amira M Abd-elmonem

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist Prof. Physiacl therapy for pediatric department, faculty of physical therapy , Cairo university

Study Record Dates

First Submitted

December 10, 2022

First Posted

December 20, 2022

Study Start

February 1, 2023

Primary Completion

February 15, 2024

Study Completion

February 15, 2024

Last Updated

December 20, 2022

Record last verified: 2022-12

Locations