The Impact of an 8-week Supported Exercise Program on Fitness and Symptoms in Adolescents With Down Syndrome

NCT03192540 | Completed

• 1 other identifier: P00023661
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

This study explores the effects of an eight-week exercise intervention for adolescents with Down syndrome on home exercise compliance. As well, to observe changes in fitness including muscular strength, endurance and aerobic capacity. Finally to observe any changes in mood, behavior and quality of life.

Conditions

Down Syndrome

Keywords

Exercise; Fitness; Overall wellbeing

Outcome Measures

Primary Outcomes (1)

• Home Exercise Compliance

  To establish if the participant is performing the same amount of exercise each week, for up to three months after the stopped visiting the group exercise sessions.

  2 months post completion of the exercise program

Secondary Outcomes (4)

• Muscular strength & endurance

  The test will be performed before the exercise intervention and then after 8 weeks of exercise intervention.

• Aerobic capacity

  The test will be preformed before the exercise intervention and then after 8 weeks of exercise intervention.

• Anxiety and Depression Symptoms

  The scale will be given the before the exercise intervention begins and then after 8 weeks of exercise intervention.

• Behavioral Symptoms

  The scale will be given the before the exercise intervention begins and then after 8 weeks of exercise intervention.

Study Arms (1)

Exercise

EXPERIMENTAL

These are participants who will be undergoing exercise intervention.

Other: Exercise

Interventions

Exercise OTHER

Participants will undergo an exercise protocol once a week, for eight weeks. Exercise will be continuous for one hour.

Exercise

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Males and females
• to 17 years old (until 18th birthday)
• Diagnosed with Down syndrome by a physician
• Medically cleared to exercise

You may not qualify if:

• Requires consistent one-on-one care
• History of behavioral issues (outbursts, aggressive/self-injurious, bolting)
• Pre-existing cardiovascular, respiratory or orthopedic conditions that could place participant at risk for injury or illness resulting from exercise. For example:
• Untreated significant atlantoaxial instability
• Severe pulmonary hypertension

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02446, United States

Location

MeSH Terms

Conditions

Down Syndrome; Motor Activity

Interventions

Exercise

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; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: May 15, 2017
• First Posted: June 20, 2017
• Study Start: September 15, 2018
• Primary Completion: December 31, 2020
• Study Completion: March 31, 2021
• Last Updated: January 26, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)