Effects of High Intensity Interval Training in Down Syndrome

NCT06777394 | Recruiting DMC

• 1 other identifier: REC/RCR & AHS/24/0718
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Down Syndrome

Keywords

Down Syndrome,.; High intensity interval training; Endurance; Trunk Stability

Outcome Measures

Primary Outcomes (1)

• Four square balance test

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

  6 weeks

Secondary Outcomes (1)

• 6 minutes walk test for endurance

  6 weeks

Study Arms (2)

Experimental group

EXPERIMENTAL

task oriented training, group A perform high intensity interval training in addition to routine physical therapy routine exercise giving short burst of intense work for 15 second to 4 mins

Other: High intensity interval training

control group

OTHER

Routine treatment , streching and normal range of motion exercise should be taught to the patients. low intensity and aerobic exercise perform

Other: Routine treatmet

Interventions

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

Experimental group

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.

control group

Eligibility Criteria

• Age: 3 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Any neurological condition
• History of dementia

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Riphah international University

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

Related Publications (1)

• Antonarakis SE, Skotko BG, Rafii MS, Strydom A, Pape SE, Bianchi DW, Sherman SL, Reeves RH. Down syndrome. Nat Rev Dis Primers. 2020 Feb 6;6(1):9. doi: 10.1038/s41572-019-0143-7.

  PMID: 32029743 BACKGROUND

MeSH Terms

Conditions

Down Syndrome

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Sheza Khan, MS*

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Imran Amjad, PhD

CONTACT

033224390125; imranamjad@riphah.edu.pk

Muhammad Aif Javed, MS

CONTACT

03224209422; a.javed@riphah.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single (Participants) Participants will get separate treatment protocols and possible efforts will be put to mask the both group about the treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel Assignment it will be randomized control trail in which non probability convenient sampling will be used . Two groups of 3-14 age will be formed in which participants will be randomly divided. Group A will be receive Group Task- Oriented Training. Group B wil be receive routine therapy

Study Record Dates

• First Submitted: November 3, 2024
• First Posted: January 15, 2025
• Study Start: October 27, 2024
• Primary Completion: January 15, 2025
• Study Completion: January 15, 2025
• Last Updated: January 15, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)