Down SyndromeNCT04647851
Remote Exercise Study for Individuals With Down Syndrome
A study testing Remote exercise intervention Down syndrome in people with Down Syndrome, run by University of Nevada, Las Vegas at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Down Syndrome
- What is being tested?
- Remote exercise intervention Down syndrome
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Nov 2020to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nevada, Las Vegas
Las Vegas, Nevada, 89154
About this study
Official title: Effects of a Remote Exercise Intervention on Aerobic Endurance, Strength, Gait and Balance in Individuals With Down Syndrome - Pilot Study
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.
Read the 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).
- Conditions
- Down Syndrome
- Being tested
- Remote exercise intervention Down syndrome
- Medical subject headings
- Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote exercise intervention Down syndromeOther
See arm description
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Remote exercise intervention Down syndrome |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aerobic endurance
We measure aerobic endurance with the 2-min Step Test, outcome measure is number of times the right leg is lifted.
Measured: 13 weeks
Secondary outcomes (8)
Leg strength
30 Second Chair Stand, measured in number of times to stand up.
Measured: 13 weeks
Leg strength
5 times Chair Stand, measured in number of seconds it takes to stand up and sit down 5 times.
Measured: 13 weeks
Balance
Timed Up and Go, measured in seconds to complete task.
Measured: 13 weeks
Balance
Modified CTSIB (Clinical Test on Sensory Information on Balance), measured in seconds
Measured: 13 weeks
Balance
FICSIT-4 (Frailty and Injuries: Cooperative Studies of Intervention Techniques, measured in seconds
Measured: 13 weeks
Balance
Functional reach, measured in centimeter
Measured: 13 weeks
Gait
Walking speed, measured in meter/second
Measured: 13 weeks
Gait
Observational Gait Analysis, measured in total score for deviations
Measured: 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2020
- Study start18 Nov 2020
- Primary completion31 Dec 2021
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Down SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pre- and post test design
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nevada, Las Vegas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thessa Hilgenkamp, University of Nevada, Las Vegas
- Investigators
- Thessa Hilgenkamp, Ph.D, Principal investigator, University of Nevada, Las Vegas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04647851
- Sponsor's protocol ID
- 1442844Pilot
- Status last verified
- May 2023
- First submitted
- 24 Nov 2020
- Last updated
- 26 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified individual patient data will be made available to other researchers upon request.
Publications
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.
PubMed 38481070Guerrero 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.
PubMed 36585748
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Remote Exercise Intervention on Aerobic Endurance, Strength, Gait and Balance in Individuals With Down Syndrome - Pilot Study
- ClinicalTrials.gov ID
- NCT04647851
- Acronym / sponsor ID
- 1442844Pilot
- Conditions
- Down Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Nevada, Las VegasUniversity, hospital or other
- Study start
- 18 Nov 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 1 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pre- and post test design
| Arm | Type | Receives |
|---|---|---|
| Remote exercise intervention Down syndrome | Experimental | Other: Remote exercise intervention Down syndromeIntervention: 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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:
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote exercise intervention Down syndromeSee arm description | Other | Remote exercise intervention Down syndrome |
Primary outcome
Aerobic endurance
Time frame: 13 weeks
We measure aerobic endurance with the 2-min Step Test, outcome measure is number of times the right leg is lifted.
8 secondary outcomes
Leg strength
Time frame: 13 weeks
Leg strength
Time frame: 13 weeks
Balance
Time frame: 13 weeks
Balance
Time frame: 13 weeks
Balance
Time frame: 13 weeks
Balance
Time frame: 13 weeks
Gait
Time frame: 13 weeks
Gait
Time frame: 13 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2023.
- Derived from this study: PubMed 38481070Hilgenkamp 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.
- Derived from this study: PubMed 36585748Guerrero 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.
- Individual participant dataSharing planned: No. De-identified individual patient data will be made available to other researchers upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thessa Hilgenkamp, Ph.D principal investigator
University of Nevada, Las Vegas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote exercise intervention Down syndrome in people with Down Syndrome, run by University of Nevada, Las Vegas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aerobic endurance (time frame: 13 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04647851, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2023.