NCT06895642

Brief Summary

The aim of the study was to develop an active video-based high-intensity interval exercise system for the rehabilitation programs of children with asthma and to compare its immediate effects on heart rate variability, hemodynamic responses and thermal responses with a conventional high-intensity interval exercise.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2024

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 30, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 18, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 26, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

March 26, 2025

Status Verified

March 1, 2025

Enrollment Period

8 months

First QC Date

March 18, 2025

Last Update Submit

March 25, 2025

Conditions

Keywords

high intensity interval trainingvideo-based exerciseasthmatic childrenimmediate response

Outcome Measures

Primary Outcomes (2)

  • Heart rate variability

    Heart rate variability will be measured in one minute immediately before exercise, in one minute immediately after exercise, and 5 and 10 minutes during recovery with Polar H10.

    Before exercise immediately (in one minute), after exercise immediately (in one minute), and 5th and 10th minutes of the recovery period

  • Heart rate

    Heart rate will be measured in one minute immediately before exercise, in one minute immediately after exercise, and 5 and 10 minutes during recovery with Polar H10.

    Before exercise immediately (in one minute), after exercise immediately (in one minute), and 5th and 10th minutes of the recovery period

Study Arms (2)

Video-based High Intensity Interval Training

EXPERIMENTAL

Participants in this group will perform a video feedback and treadmill-based exercise.

Other: Exercise

Conventional High Intensity Interval Training

ACTIVE COMPARATOR

Participants in this group will perform a treadmill-based exercise.

Other: Exercise

Interventions

After all of the participants perform a symptom-limited cardiopulmonary exercise test, they included a single session high intensity interval exercise created according to test results. They randomized to two gorups as video and treadmill-based or only treadmill-based high intensity interval exercise.

Conventional High Intensity Interval TrainingVideo-based High Intensity Interval Training

Eligibility Criteria

Age8 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Having asthma diagnosis according to GINA criteria
  • Being between 8-15 years of age
  • Having stabil asthma
  • Coming to routine follow-ups regularly
  • Being under regular pharmacological treatment and having good compliance with treatment confirmed by a physician
  • Volunteering to participate in the study (both child and parent)

You may not qualify if:

  • Having another diagnosed chronic disease other than asthma
  • Obesity (Body mass index over 25
  • Not having stable asthma defined as having had an exacerbation in the last 4 weeks
  • Having severe persistent asthma
  • Having exercise-induced asthma
  • Not being able to complete the exercise capacity test
  • Not being able to maintain the intensity of exercise ±5%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Manisa Celal Bayar University

Manisa, Manisa, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants only know that they will perform a treadmill and video-based high-intensity interval exercise. They will randomize as video-based or conventional high-intensity interval exercise groups.
Purpose
SCREENING
Intervention Model
PARALLEL
Model Details: Randomised controlled interventional study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 18, 2025

First Posted

March 26, 2025

Study Start

September 30, 2024

Primary Completion

June 1, 2025

Study Completion

September 1, 2025

Last Updated

March 26, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations