- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05577286
Therapeutic Effects of Plyometric Exercises in Children With Type 1 Diabetis
December 1, 2022 updated by: Amira Mahmoud Abd-elmonem, Cairo University
Despite the benefits of physical rehabilitation among adults and children with chronic illness such as Diabetes mellitus avoid engaging in different physical activities especially pediatric population.
Most of the children with type 1 Diabetes mellitus receive their medical treatment and follow-up with no change of their functional performance.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
We still lack the evidence of plyometric exercises in pediatric population with Diabetes mellitus .
Therefore, the primary aim of this study is to explore the effects of plyometric exercises on blood glucose level, balance and muscle strength in children with 1 Diabetes mellitus
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Not Applicable
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
6 years to 10 years (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age will range from six to 10 years
- Both sexes
- Chronicity of the disease ranges from 3 to <5 years.
- Controlled diabetes with insulin dosage described by physician.
Exclusion Criteria:
- Heriderty sensory or autonomic peripheral neuropathy.
- Unstable cardio-vascular disorders
- History of fractures or surgery in the lower extremities in the past 12 months.
- Diagnosed with other hormonal diseases.
- Children who practice regular sports.
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
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: control group
15 Children with type 1 Diabetes mellitus in this group will receive the regular medical treatment without change of their daily activity routine
|
the regular medical treatment without change of their daily activity routine
|
EXPERIMENTAL: plyometric group
15 Children with type 1 Diabetes mellitus in this group will receive the regular medical treatment as in control group in addition to a designed plyometric training program for 30 minutes, three times a week for two successive months.
|
the regular medical treatment without change of their daily activity routine
designed plyometric training program for 30 minutes, three times a week for two successive months
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
muscle strength
Time Frame: after 3 successive months
|
assessment of hip, knee and ankle muscles by The Laffayette manual muscle testing (model 01163 USA) which measure strength in kG.
|
after 3 successive months
|
balance
Time Frame: after 3 successive months
|
assessment of balance by The Human Assessment Computer (HUMAC), a computerized dynamic posturography (commuter sports medicine, Inc., Stoughton, MA).
|
after 3 successive months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Doaa A Mahmoud Sanad, Phd, Cairo university, faculty of physical therapy
- Principal Investigator: Samya M Aly Hussein, B.Sc., Cairo university, faculty of physical therapy
- Study Director: Aboalnaga A Abdelrahim Hamed, Cairo university, faculty of physical therapy
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)
January 1, 2023
Primary Completion (ANTICIPATED)
January 30, 2023
Study Completion (ANTICIPATED)
November 30, 2024
Study Registration Dates
First Submitted
September 27, 2022
First Submitted That Met QC Criteria
October 9, 2022
First Posted (ACTUAL)
October 13, 2022
Study Record Updates
Last Update Posted (ACTUAL)
December 2, 2022
Last Update Submitted That Met QC Criteria
December 1, 2022
Last Verified
December 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- type 1 diabetes
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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