Ignite Creation Date:
2024-05-06 @ 3:29 PM
Last Modification Date:
2024-10-26 @ 1:50 PM
Study NCT ID:
NCT04647851
Status:
COMPLETED
Last Update Posted:
2023-05-26
First Post:
2020-11-24
Brief Title:
Remote Exercise Study for Individuals With Down Syndrome
Sponsor:
University of Nevada Las Vegas
Organization:
University of Nevada Las Vegas
Study Overview
Official Title:
Effects of a Remote Exercise Intervention on Aerobic Endurance Strength Gait and Balance in Individuals With Down Syndrome - Pilot Study
Status:
COMPLETED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 3hrswk 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 visualvestibular 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 participants walking
Additionally participants andor parentscaregivers 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
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 visualvestibular 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 participants walking
Additionally participants andor parentscaregivers 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None