Remote Exercise Study for Individuals With Down Syndrome

Sponsor

University of Nevada, Las Vegas (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04647851

Collaborator

(none)

Enrollment

Location

Arm

25.4

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Down Syndrome	Other: Remote exercise intervention Down syndrome	N/A

Detailed Description

Design: Repeated measures design: 20 participants will participate in the remote exercise intervention study with a pre-test and a post-test to investigate training effects on aerobic endurance, strength, balance and gait.

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.

Measurements: We will use only field tests instead of the original lab-based testing for aerobic endurance, strength, balance and gait, and all tests will be conducted remotely.

Baseline measurements: height, weight, circumferences Aerobic endurance: 2 Minute Step Test:

participant marches in place as fast as possible with a set height for how high to lift the knees, for two minutes. Outcome is heart rate and number of steps in two minutes.

Strength: 30 Second Chair Stand and 5 Times Chair Stand: participants starts seated, then stands up and sits down as fast as possible, first counting the number of times within 30 seconds, then timing the number of seconds for 5 times.

Balance: Timed Up and Go: This is a timed test where the participant stands up from a chair, walk 10ft, turn around, walk back and sit down again, as fast as possible. Modified CTSIB (Clinical Test on Sensory Information on Balance) and FICSIT-4 (Frailty and Injuries: Cooperative Studies of Intervention Techniques): Standing balance in different conditions and positions. Functional Reach Test: Reaching from a standing position as far as possible.

Gait: Comfortable and Fast Walking Speed, Observational Gait Analysis based on anterior, posterior and lateral video recordings of the participant's walking.

Additionally, participants (and/or parents/caregivers for the group with Down syndrome) will complete a health history questionnaire and physical activity questionnaire, a questionnaire about risk of falling (Short Falls Efficacy Scale-1) and about attitudes towards exercise (Health Matters Evaluation Toolkit).

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Pre- and post test designPre- and post test design

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Effects of a Remote Exercise Intervention on Aerobic Endurance, Strength, Gait and Balance in Individuals With Down Syndrome - Pilot Study

Actual Study Start Date :

Nov 18, 2020

Actual Primary Completion Date :

Dec 31, 2021

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Remote exercise intervention Down syndrome 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 See arm description

Arm

Intervention/Treatment

Experimental: Remote exercise intervention Down syndrome

Other: Remote exercise intervention Down syndrome

See arm description

Outcome Measures

Primary Outcome Measures

Aerobic endurance [13 weeks]
We measure aerobic endurance with the 2-min Step Test, outcome measure is number of times the right leg is lifted.

Secondary Outcome Measures

Leg strength [13 weeks]
30 Second Chair Stand, measured in number of times to stand up.
Leg strength [13 weeks]
5 times Chair Stand, measured in number of seconds it takes to stand up and sit down 5 times.
Balance [13 weeks]
Timed Up and Go, measured in seconds to complete task.
Balance [13 weeks]
Modified CTSIB (Clinical Test on Sensory Information on Balance), measured in seconds
Balance [13 weeks]
FICSIT-4 (Frailty and Injuries: Cooperative Studies of Intervention Techniques, measured in seconds
Balance [13 weeks]
Functional reach, measured in centimeter
Gait [13 weeks]
Walking speed, measured in meter/second
Gait [13 weeks]
Observational Gait Analysis, measured in total score for deviations

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Nevada, Las Vegas	Las Vegas	Nevada	United States	89154

Sponsors and Collaborators

University of Nevada, Las Vegas

Investigators

Principal Investigator: Thessa Hilgenkamp, Ph.D, University of Nevada, Las Vegas

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Study information on UNLVPT CARE-Lab website

Publications

None provided.

Responsible Party:

Thessa Hilgenkamp, Assistant Professor, University of Nevada, Las Vegas

ClinicalTrials.gov Identifier:

NCT04647851

Other Study ID Numbers:

1442844Pilot

First Posted:

Dec 1, 2020

Last Update Posted:

May 17, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Down Syndrome

Syndrome

Study Results

No Results Posted as of May 17, 2022