Moderate Versus High-intensity Interval Training in Child... | NCT07289373

Studies
Moderate Versus High-intensity Interval Training in Children With Diplegia.

NCT07289373

Sponsor

Cairo University

Status

Completed

Last Update Posted

Dec 17, 2025Actual

Enrollment

30Actual

Phase

Not Applicable

Conditions

Cerebral Palsy

Interventions

Moderate intensity training
High intensity interval training

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 23, 2024Actual

Primary Completion Date

Mar 10, 2025Actual

Completion Date

Mar 10, 2025Actual

First Submitted Date

Dec 4, 2025

First Submission Date that Met QC Criteria

Dec 4, 2025

First Posted Date

Dec 17, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 4, 2025

Last Update Posted Date

Dec 17, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mai Elsayed Abbass, Assisstant Proffessor, Faculty of Physical Therapy, Cairo University, Cairo UniversityPrincipal Investigator

Lead Sponsor

Cairo UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim is to compare the effects of moderate-intensity training and high-intensity interval training on gait, energy expenditure, and functional mobility in children with spastic diplegia. Methods: Thirty children with spastic diplegic cerebral palsy were allocated randomly into two groups (n=15 each). The group A and the group B. Assessment of functional mobility and energy expenditure and gait analysis for all children of both groups were assessed before and after the suggested period of treatment.

Detailed Description

Methods: Thirty children with with spastic diplegic cerebral palsy were allocated randomly into two groups ( n= 15 each). The group A (received aerobic training with moderate intensity endurance training "MIET" by walking or running on a treadmill) and the group B (received aerobic training exercises in a form of high intensity interval training "HIT" by walking or running on a treadmill). Treatment was delivered for 20minutes, 3 times per week for two successive months. Assessment of functional mobility and energy expenditure using Timed Up and Go(TUG) test and Energy Expenditure Index Heart Rate(EEIHR) respectively, while gait analysis for both lower limb angles of (hips and Knees) assessment using 2d gait analysis by( Kinovea) software. All children of both groups assessed before and after the suggested period of treatment.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group A	Experimental	Group A (received aerobic training with moderate intensity endurance training "MIET" by walking or running on a treadmill). Treatment was delivered for 20minutes, 3 times per week for two successive months.	Procedure: Moderate intensity training
Group B	Experimental	Group B (received aerobic training exercises in the form of high-intensity interval training (HIT) by walking or running on a treadmill). Treatment was delivered for 20minutes, 3 times per week for two successive months.	Procedure: High intensity interval training

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Moderate intensity training	Procedure	Moderate-intensity endurance training (MIET) by walking or running on a treadmill	Group A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Gait	Assessed by 2D gait analysis	2 months
Functional mobility	Assessed by Time Up and Go test	2 months
Energy Expenditure	Assessed by Energy Expenditure Index Heart Rate	2 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Their age ranged from 3 to 5 years old
The degree of spasticity ranged from 1+ to 2 according to modified Ashworth scale
They were able to walk with limitations or holding on according to Gross Motor Function Classification System (II, III).
They were able to follow instructions and understand commands.
They were medically stable.

Exclusion criteria:

Children who had bone and tendon lengthening surgeries within the last 6 months.
Children with lung and heart diseases and disorders.
Children with fixed deformities in joints and bones of lower limbs.
Children performing different sorts of physical activities.
Children receiving any medications affecting muscle and mental function or antiepileptic drugs that affect the mental function.
Children with perceptual defects.
Children with any visual or sound-related issues.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

5 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mai E. Abbass	Cairo University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Physical Therapy, Cairo University		Giza			Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002547	Cerebral Palsy

Ancestor Terms

ID	Term
D001925	Brain Damage, Chronic
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000072696	High-Intensity Interval Training

Ancestor Terms

ID	Term
D064797	Physical Conditioning, Human
D015444	Exercise
D009043	Motor Activity
D009068	Movement

Browse Leaves

Not provided

Browse Branches

Not provided