Remote Exercise Study for Individuals With Down Syndrome

NCT04647851 | Completed

• 1 other identifier: 1442844Pilot
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot study aims to test whether remote delivery of the exercise intervention provides a sufficient training stimulus. This pilot study will be remote and online-only, and will have no in-person interaction, data collection or intervention. 20 Participants will participate in a 12-wk, 3hrs/wk remote exercise intervention and in a pre- and a posttest remote testing session. We will use Zoom for all testing and exercise sessions.

Conditions

Down Syndrome

Outcome Measures

Primary Outcomes (1)

• Aerobic endurance

  We measure aerobic endurance with the 2-min Step Test, outcome measure is number of times the right leg is lifted.

  13 weeks

Secondary Outcomes (8)

• Leg strength

  13 weeks

• Leg strength

  13 weeks

• Balance

  13 weeks

• Balance

  13 weeks

• Balance

  13 weeks

Study Arms (1)

Remote exercise intervention Down syndrome

EXPERIMENTAL

Intervention: The program we will be using is specifically developed for individuals with Down syndrome based on the Mann Method PT Principles. The MMPT Principles TM focus on a progressive program of therapeutic activity (cardiovascular activity), therapeutic exercise (foundational strengthening and hip strengthening activities), and neuromuscular rehabilitation (visual/vestibular and balance activities) to address the unique needs of individuals with Down syndrome. This program has been developed and successfully implemented in Down syndrome activity centers across the country. This program will be offered through Zoom. Intensity will be submaximal for both data collection and during the exercise sessions, and recorded with Polar heart rate monitors.

Other: Remote exercise intervention Down syndrome

Interventions

Remote exercise intervention Down syndrome OTHER

See arm description

Remote exercise intervention Down syndrome

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Between 18 and 35 years old
• generally healthy
• sedentary (defined as being involved in less than 30 minutes of moderately-intense physical activity per day)
• additionally for the participants with Down syndrome:
• diagnosis of Down syndrome trisomy 21 and
• normal thyroid function or stable thyroid function (and medications) for at least 6 mo.

You may not qualify if:

• congenital heart disease;
• atherosclerotic or other vascular disease;
• asthma or other pulmonary disease;
• hypertension (defined BP \>140/90 mmHg);
• blood pressure below 90/60 mmHg;
• history of pre-syncope or syncope;
• diabetes (defined as Hba1c of \>7.5% or use of glucose lowering medication);
• severe obesity (defined as BMI \>40);
• medications affecting heart rate, blood pressure or arterial function;
• anti-inflammatory medication including NSAIDS;
• current smoking and
• pregnancy.

Sponsors & Collaborators

• University of Nevada, Las Vegas: lead

Study Sites (1)

University of Nevada, Las Vegas

Las Vegas, Nevada, 89154, United States

Location

Related Publications (2)

• Hilgenkamp T, Lum R, Roys C, Souza T, Stopka D, Mann S, Ho KY. Effects of a 12-week telehealth exercise intervention on gait speed and gait deviations in adults with Down syndrome. J Intellect Disabil Res. 2024 Jun;68(6):598-609. doi: 10.1111/jir.13132. Epub 2024 Mar 13.

  PMID: 38481070 DERIVED

• Guerrero K, Umagat A, Barton M, Martinez A, Ho KY, Mann S, Hilgenkamp T. The effect of a telehealth exercise intervention on balance in adults with Down syndrome. J Appl Res Intellect Disabil. 2023 Mar;36(2):385-393. doi: 10.1111/jar.13068. Epub 2022 Dec 30.

  PMID: 36585748 DERIVED

MeSH Terms

Conditions

Down Syndrome

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

Study Officials

• Thessa Hilgenkamp, Ph.D

  University of Nevada, Las Vegas

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Pre- and post test design

Study Record Dates

• First Submitted: November 24, 2020
• First Posted: December 1, 2020
• Study Start: November 18, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2022
• Last Updated: May 26, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)