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Exercise Intensity for Down Syndrome Children

Primary Purpose

Down Syndrome

Status

Completed

Phase

Not Applicable

Locations

Saudi Arabia

Study Type

Interventional

Intervention

treadmill exercise (mild)

treadmill exercise (moderate)

About this trial

This is an interventional treatment trial for Down Syndrome

Eligibility Criteria

8 Years - 12 Years (Child)MaleDoes not accept healthy volunteers

Inclusion Criteria:

independent walking
Intelligence quotient range from 40 to 70
right dominant foot
body mass index from 50 to 75

Exclusion Criteria:

chronic diseases
congenital anomalies
involved in any competitive sport
previous injury to the lower limb

Sites / Locations

College of Applied Medical Sciemces

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

mild intensity group

moderate intensity group

Arm Description

Received mild intensity treadmill training according to Martti Karvonen's formula.

Received moderate intensity treadmill training according to Martti Karvonen's formula.

Outcomes

Primary Outcome Measures

knee extensor peak torque

eccentric normalized peak torque of the knee extensors of the dominant limb.

ankle plantar fexors peak torque

eccentric normalized peak torque of the ankle plantar flexors of the dominant limb.

functional mobility

the assessment of the time up and go test

Secondary Outcome Measures

Full Information

NCT ID

NCT05271201

First Posted

February 26, 2022

Last Updated

February 26, 2022

Sponsor

Taif University

1. Study Identification

Unique Protocol Identification Number

NCT05271201

Brief Title

Exercise Intensity for Down Syndrome Children

Official Title

Effect of Exercise Intensity on Knee and Ankle Joints' Torque and Functional Mobility in Children With Down's Syndrome: a Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Completed

Study Start Date

December 10, 2019 (Actual)

Primary Completion Date

March 15, 2020 (Actual)

Study Completion Date

March 27, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Taif University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

The current study aimed to determine the appropriate exercise intensity for the rehabilitation of children with down syndrome.

Detailed Description

Two groups of down syndrome children were recruited. one group received mild-intensity treadmill training while the other received moderate-intensity treadmill training. Eccentric knee extensors and ankle plantar flexors peak torques were assessed before and after the intervention. Also, functional mobility was assessed for both groups before and after the intervention. The within and between-subjects effect was used to analyze the obtained data before and after the intervention. isokinetic dynamometer and the time up and go test were used for evaluation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Down Syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

34 (Actual)

8. Arms, Groups, and Interventions

Arm Title

mild intensity group

Arm Type

Experimental

Arm Description

Received mild intensity treadmill training according to Martti Karvonen's formula.

Arm Title

moderate intensity group

Arm Type

Experimental

Arm Description

Received moderate intensity treadmill training according to Martti Karvonen's formula.

Intervention Type

Other

Intervention Name(s)

treadmill exercise (mild)

Intervention Description

mild intensity treadmill training.

Intervention Type

Other

Intervention Name(s)

treadmill exercise (moderate)

Intervention Description

moderate-intensity treadmill training

Primary Outcome Measure Information:

Title

knee extensor peak torque

Description

eccentric normalized peak torque of the knee extensors of the dominant limb.

Time Frame

three months

Title

ankle plantar fexors peak torque

Description

eccentric normalized peak torque of the ankle plantar flexors of the dominant limb.

Time Frame

three months

Title

functional mobility

Description

the assessment of the time up and go test

Time Frame

three months

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

8 Years

Maximum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: independent walking Intelligence quotient range from 40 to 70 right dominant foot body mass index from 50 to 75 Exclusion Criteria: chronic diseases congenital anomalies involved in any competitive sport previous injury to the lower limb

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hatem H Allam, ass. prof.

Organizational Affiliation

Taif University

Official's Role

Principal Investigator

Facility Information:

Facility Name

College of Applied Medical Sciemces

City

Ta'if

State/Province

Mecca

ZIP/Postal Code

2425

Country

Saudi Arabia

12. IPD Sharing Statement

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