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Remote Exercise Study for Individuals With Down Syndrome

Primary Purpose

Down Syndrome

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Remote exercise intervention Down syndrome
Sponsored by
University of Nevada, Las Vegas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Down Syndrome

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Nevada, Las Vegas

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Remote exercise intervention Down syndrome

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Full Information

First Posted
November 24, 2020
Last Updated
May 24, 2023
Sponsor
University of Nevada, Las Vegas
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1. Study Identification

Unique Protocol Identification Number
NCT04647851
Brief Title
Remote Exercise Study for Individuals With Down Syndrome
Official Title
Effects of a Remote Exercise Intervention on Aerobic Endurance, Strength, Gait and Balance in Individuals With Down Syndrome - Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
November 18, 2020 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Nevada, Las Vegas

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Down Syndrome

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Pre- and post test design
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Remote exercise intervention Down syndrome
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Remote exercise intervention Down syndrome
Intervention Description
See arm description
Primary Outcome Measure Information:
Title
Aerobic endurance
Description
We measure aerobic endurance with the 2-min Step Test, outcome measure is number of times the right leg is lifted.
Time Frame
13 weeks
Secondary Outcome Measure Information:
Title
Leg strength
Description
30 Second Chair Stand, measured in number of times to stand up.
Time Frame
13 weeks
Title
Leg strength
Description
5 times Chair Stand, measured in number of seconds it takes to stand up and sit down 5 times.
Time Frame
13 weeks
Title
Balance
Description
Timed Up and Go, measured in seconds to complete task.
Time Frame
13 weeks
Title
Balance
Description
Modified CTSIB (Clinical Test on Sensory Information on Balance), measured in seconds
Time Frame
13 weeks
Title
Balance
Description
FICSIT-4 (Frailty and Injuries: Cooperative Studies of Intervention Techniques, measured in seconds
Time Frame
13 weeks
Title
Balance
Description
Functional reach, measured in centimeter
Time Frame
13 weeks
Title
Gait
Description
Walking speed, measured in meter/second
Time Frame
13 weeks
Title
Gait
Description
Observational Gait Analysis, measured in total score for deviations
Time Frame
13 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thessa Hilgenkamp, Ph.D
Organizational Affiliation
University of Nevada, Las Vegas
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Nevada, Las Vegas
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89154
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
De-identified individual patient data will be made available to other researchers upon request.
Links:
URL
https://unlvptlabs.com/research-projects/
Description
Study information on UNLVPT CARE-Lab website

Learn more about this trial

Remote Exercise Study for Individuals With Down Syndrome

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