- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05657236
Effect of Strength and Conditioning Training on Functional Performance in Children With Chronic Kidney Disease
December 10, 2022 updated by: Amira Mahmoud Abd-elmonem, Cairo University
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 .
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
30
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: Amira M Abd-elmonem
- Phone Number: 01155553316
- Email: Dramira.salim2020@gmail.com
Study Locations
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Giza, Egypt, 12662
- Amira Mahmoud Abd-elmonem
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Contact:
- Amira M Abd-elmonem
- Email: Dramira.salim2020@gmail.com
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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
2 years to 2 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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).
Exclusion Criteria:
- Recent myocardial infarction, uncontrolled hypertension, unstable angina, symptomatic left ventricular fibrillation.
- Severe uncontrolled diabetes,
- Neurological or cognitive disorders
- Peripheral vascular disease.
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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Experimental group
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traditional medical treatment and regular follow-up
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.
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Other: control group
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traditional medical treatment and regular follow-up
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Balance
Time Frame: after 2 months
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The Human Assessment Computer (HUMAC), a computerized dynamic posturography (commuter sports medicine, Inc., Stoughton, MA),will be used in the current study.
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after 2 months
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muscle strength
Time Frame: after 2 months
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The Laffayette manual muscle testing (model 01163 USA) is used for objectively quantifying muscle strength including hip flexors and abductors; knee flexors and extensors
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after 2 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Amira M Mahmoud, Cairo university, faculty of physical therapy
- Study Chair: Amira M Al-tohamy, Cairo university, faculty of physical therapy
- Study Director: Rasha M Helmy, 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 (Anticipated)
February 1, 2023
Primary Completion (Anticipated)
February 15, 2024
Study Completion (Anticipated)
February 15, 2024
Study Registration Dates
First Submitted
December 10, 2022
First Submitted That Met QC Criteria
December 10, 2022
First Posted (Estimate)
December 20, 2022
Study Record Updates
Last Update Posted (Estimate)
December 20, 2022
Last Update Submitted That Met QC Criteria
December 10, 2022
Last Verified
December 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- chronic kidney disease
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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-
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-
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