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Therapeutic Effects of Plyometric Exercises in Children With Type 1 Diabetis

Primary Purpose

Diabetes Mellitus, Type 1

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
regular care
plyometric training
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 1 focused on measuring Diabetes mellitus, type 1 1 Diabetes mellitus, plyometric exercises, balance, muscle strength

Eligibility Criteria

6 Years - 10 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Experimental

    Arm Label

    control group

    plyometric group

    Arm Description

    15 Children with type 1 Diabetes mellitus in this group will receive the regular medical treatment without change of their daily activity routine

    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.

    Outcomes

    Primary Outcome Measures

    muscle strength
    assessment of hip, knee and ankle muscles by The Laffayette manual muscle testing (model 01163 USA) which measure strength in kG.
    balance
    assessment of balance by The Human Assessment Computer (HUMAC), a computerized dynamic posturography (commuter sports medicine, Inc., Stoughton, MA).

    Secondary Outcome Measures

    Full Information

    First Posted
    September 27, 2022
    Last Updated
    December 1, 2022
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05577286
    Brief Title
    Therapeutic Effects of Plyometric Exercises in Children With Type 1 Diabetis
    Official Title
    Therapeutic Effects of Plyometric Exercises in Children With Type 1 Diabetis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 1, 2023 (Anticipated)
    Primary Completion Date
    January 30, 2023 (Anticipated)
    Study Completion Date
    November 30, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    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.
    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetes Mellitus, Type 1
    Keywords
    Diabetes mellitus, type 1 1 Diabetes mellitus, plyometric exercises, balance, muscle strength

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    control group
    Arm Type
    Other
    Arm Description
    15 Children with type 1 Diabetes mellitus in this group will receive the regular medical treatment without change of their daily activity routine
    Arm Title
    plyometric group
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    regular care
    Intervention Description
    the regular medical treatment without change of their daily activity routine
    Intervention Type
    Other
    Intervention Name(s)
    plyometric training
    Intervention Description
    designed plyometric training program for 30 minutes, three times a week for two successive months
    Primary Outcome Measure Information:
    Title
    muscle strength
    Description
    assessment of hip, knee and ankle muscles by The Laffayette manual muscle testing (model 01163 USA) which measure strength in kG.
    Time Frame
    after 3 successive months
    Title
    balance
    Description
    assessment of balance by The Human Assessment Computer (HUMAC), a computerized dynamic posturography (commuter sports medicine, Inc., Stoughton, MA).
    Time Frame
    after 3 successive months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    10 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Amira M Abd-elmonem, PhD
    Phone
    01155553316
    Email
    Dramira.salim2020@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Doaa A Mahmoud Sanad, Phd
    Organizational Affiliation
    Cairo university, faculty of physical therapy
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Samya M Aly Hussein, B.Sc.
    Organizational Affiliation
    Cairo university, faculty of physical therapy
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Aboalnaga A Abdelrahim Hamed
    Organizational Affiliation
    Cairo university, faculty of physical therapy
    Official's Role
    Study Director

    12. IPD Sharing Statement

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    Therapeutic Effects of Plyometric Exercises in Children With Type 1 Diabetis

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