Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06777394

Effects of High Intensity Interval Training in Down Syndrome

Down Syndrome (DS), a genetic condition marked by the presence of an extra chromosome 21, is associated with various cognitive and physical challenges. Children with DS often experience motor development issues, including reduced endurance and decreased trunk stability, which underscores the need for targeted interventions. Common impairments in individuals with DS include hypotonia, ligament laxity, reduced muscle strength, limited muscle co-contraction, poor postural control, and impaired proprioception. This study is driven by a lack of research on the effects of High-Intensity Interval Training (HIIT) in this population, despite its documented benefits in enhancing cardiovascular fitness across other groups. Existing literature supports the benefits of exercise interventions for people with DS, but the application and advantages of HIIT-particularly concerning endurance and trunk stability-are underexplored.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Down Syndrome Abnormalities, Multiple Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Intellectual Disability Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations

Age range

3 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

The study aims to evaluate the impact of a structured HIIT program on endurance and trunk stability in children with DS. Conducted as a randomized controlled trial (RCT) at Khuwaja Arshad Hospital, Sargodha, the study will include 30 participants divided equally and randomly assigned to two groups. The inclusion criteria include children with a confirmed DS diagnosis, aged 3 to 14, with the ability to understand instructions, stand, and walk independently, and of any gender. Exclusion criteria include mobility impairments, signs of atlantoaxial joint instability, and neurological conditions. Group A will participate in a HIIT program, while Group B will receive routine physical therapy. Pre- and post-intervention assessments will use validated tools to measure endurance (6-Minute Walk Test) and trunk stability (Functional Reach Test). Additionally, the feasibility and acceptability of the HIIT program will be qualitatively evaluated. Data will be collected at baseline and post-intervention and analyzed using SPSS version 23.Data analysis will be conducted using SPSS software. Quantitative data will be reported as mean and standard deviation and visualized with histograms, while qualitative data will be summarized as frequency and percentage and displayed using bar charts. Statistical techniques will be applied to compare baseline characteristics between groups and to assess normal distribution through the Four Square Step Test, the Six-Minute Walk Test for endurance, and the Functional Reach Test for trunk stability. If data follow a normal distribution, within-group differences will be analyzed using a paired sample t-test; otherwise, the Wilcoxon Signed Rank test, a non-parametric alternative, will be applied. For between-group differences, an independent sample t-test will be used for normally distributed data, while the Mann-Whitney U test will be used for non-normally distributed data. A 95% confidence interval and a significance level of p < 0.05 will be considered significant.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age group between 3 to 14 years
  • clinically diagnose in children with down syndrome

Exclusion criteria

  • Any neurological condition
  • History of dementia

Treatment and study plan

High Intensity Interval Training

Other

The HIIT program begins with a warm-up, followed by high-intensity repetitions separated by moderate-intensity recovery intervals. High-intensity exercises are performed near maximum effort, while moderate-intensity periods are maintained at 50% effort. HIIT exercises, involving low-skill movements in short bursts, enhance blood sugar regulation and fat-burning capacity.

The HIIT protocol has four phases:

Warm-Up: 10 minutes, gradually increasing to about 60% of maximum heart rate. Intervals: 4 minutes at 85-95% maximum heart rate. Relief/Recovery: 3 minutes at 60% maximum heart rate, repeated four times. Cool Down: 5 minutes, bringing the heart rate down to around 50% of maximum. Three key components determine the success of HIIT: intensity, duration, and recovery period. Exercises include dumbbell and kettlebell exercises, push-ups, squats, jump training, and stationary cycling

Routine treatmet

Other

outine physical therapy includes stretching exercises, exercises to maintain a normal range of motion, and low-intensity and aerobic exercises for the patients.

Low-Intensity Exercise: The effects of low-intensity exercise become noticeable after about 20 minutes, providing a metabolic boost during the activity. Generally, a longer exercise duration further enhances metabolism.

Primary outcomes

  1. Four square balance test

    Time frame: 6 weeks

    a tool having dynamic balance and coordination. its ability to step over low objects, forward , sideways and backward

Secondary outcomes

  1. 6 minutes walk test for endurance

    Time frame: 6 weeks

    A tool used to monitor response to treatments for heart lungs and other health problem for simple measure of functional capacity

Study contacts

Contact information is provided by the study sponsor or research team.

Imran Amjad, PhD

CONTACT

[email protected]

033224390125

Muhammad Aif Javed, MS

CONTACT

[email protected]

03224209422

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Effects of High Intensity Interval Training on Endurance and Trunk Stability in Children With Down Syndrome

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 15, 2025
Registry last updated
Jan 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.