Chronic Kidney DiseasesNCT05657236
Effect of Strength and Conditioning Training on Functional Performance in Children With Chronic Kidney Disease
A study testing medical treatment and plyometric exercise in people with Chronic Kidney Diseases, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 6 years
- Conditions the study is for
- Chronic Kidney Diseases
- What is being tested?
- medical treatment and plyometric exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2023to 15 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 6 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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).
Who cannot join
- Recent myocardial infarction, uncontrolled hypertension, unstable angina, symptomatic left ventricular fibrillation.
- Severe uncontrolled diabetes,
- Neurological or cognitive disorders
- Peripheral vascular disease.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Amira Mahmoud Abd-elmonem
Giza, 12662
Amira M Abd-elmonem, Dramira.salim2020@gmail.com
About this study
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 .
- Conditions
- Chronic Kidney Diseases
- Being tested
- medical treatment, plyometric exercise
- Keywords
- Chronic Kidney Diseases, plyometric exercises, muscle strength, balance
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
medical treatmentOther
traditional medical treatment and regular follow-up
plyometric exerciseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| control group | Other | Not described Receives: Other: medical treatment |
| Experimental group | Experimental | Not described Receives: Other: medical treatment; Other: plyometric exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance
The Human Assessment Computer (HUMAC), a computerized dynamic posturography (commuter sports medicine, Inc., Stoughton, MA),will be used in the current study.
Measured: 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
Measured: after 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2022
- Study start1 Feb 2023 (estimated)
- Primary completion15 Feb 2024 (estimated)
- Study completion15 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Mahmoud Abd-elmonem, Cairo University
- Investigators
- Amira M Mahmoud, Principal investigator, Cairo university, faculty of physical therapyAmira M Al-tohamy, Study chair, Cairo university, faculty of physical therapyRasha M Helmy, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05657236
- Sponsor's protocol ID
- chronic kidney disease
- Status last verified
- Dec 2022
- First submitted
- 10 Dec 2022
- Last updated
- 20 Dec 2022
- 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 20 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Strength and Conditioning Training on Functional Performance in Children With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT05657236
- Acronym / sponsor ID
- chronic kidney disease
- Conditions
- Chronic Kidney Diseases
- Keywords
- Chronic Kidney Diseases, plyometric exercises, muscle strength, balance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Feb 2023 (estimated)
- Primary completion
- 15 Feb 2024 (estimated)
- Study completion
- 15 Feb 2024 (estimated)
- First posted
- 20 Dec 2022 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Other | Other: medical treatment |
| Experimental group | Experimental | Other: medical treatment, Other: plyometric exercise |
Who may qualify
- Ages
- 6 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (4 listed)
- Recent myocardial infarction, uncontrolled hypertension, unstable angina, symptomatic left ventricular fibrillation.
- Severe uncontrolled diabetes,
- Neurological or cognitive disorders
- Peripheral vascular disease.
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 |
|---|---|---|
| medical treatmenttraditional medical treatment and regular follow-up | Other | Experimental group, control group |
| plyometric exerciseEach 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. | Other | Experimental group |
Primary outcome
Balance
Time frame: after 2 months
The Human Assessment Computer (HUMAC), a computerized dynamic posturography (commuter sports medicine, Inc., Stoughton, MA),will be used in the current study.
muscle strength
Time frame: after 2 months
The Laffayette manual muscle testing (model 01163 USA) is used for objectively quantifying muscle strength including hip flexors and abductors; knee flexors and extensors
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2022.
Related trials for Chronic Kidney Diseases
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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. This study is not recruiting at the moment.
Amira M Mahmoud principal investigator
Cairo university, faculty of physical therapy
Amira M Al-tohamy study chair
Cairo university, faculty of physical therapy
Rasha M Helmy study director
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 medical treatment and plyometric exercise in people with Chronic Kidney Diseases, 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 5 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: status not confirmed, as of the sponsor's last update on 20 Dec 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amira M Abd-elmonem (01155553316, Dramira.salim2020@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Balance (time frame: after 2 months). The study lists 2 primary outcomes in all. 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 20 Dec 2022.