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

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.

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

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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