Your session is about to expire
← Back to Search
Exercise Intervention for Down Syndrome
N/A
Recruiting
Led By Thessa Hilgenkamp, PhD
Research Sponsored by University of Nevada, Las Vegas
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 13 weeks
Awards & highlights
Study Summary
This trial looks at the effects of exercise on people with Down Syndrome, specifically how it affects blood flow and cardiac function. They also want to see how exercise affects balance, walking, and attitude.
Who is the study for?
This trial is for generally healthy, sedentary adults with Down syndrome who have normal or stable thyroid function. It's not open to those with heart disease, vascular issues, severe lung conditions, uncontrolled blood pressure, a history of fainting episodes, diabetes, extreme obesity, or those on certain medications affecting the heart and arteries.Check my eligibility
What is being tested?
The study is testing how well people with Down syndrome respond to exercise training in terms of blood flow regulation and cardiac function. Participants will either receive combined exercise interventions or usual care to see if there are improvements in their peak oxygen consumption.See study design
What are the potential side effects?
While specific side effects aren't listed for this trial since it involves exercise intervention rather than medication, typical risks might include muscle soreness or injury from physical activity.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 13 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~13 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from Baseline Work capacity at 13 weeks
Secondary outcome measures
Change from Baseline Autonomic cardiac function at rest at 13 weeks
Change from Baseline Autonomic cardiac function during orthostasis at 13 weeks
Change from Baseline Brachial blood flow at 13 weeks
+12 moreTrial Design
3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Combined exercise intervention Down syndromeExperimental Treatment1 Intervention
The exercise intervention will last 12 weeks and will consist of a supervised combined aerobic and resistance training program with a frequency of 3 days/week.In the exercise sessions, the participant will work with the trainer on their strength, balance and aerobic endurance. Each session consists of 10 min of strength exercises (Foundational Exercise), 10 min of Hip Strengthening, 10 min of Vestibular and Balance Exercise, and 20 min of Aerobic Exercise, and starts with a warming up and ends with stretching/cooling down. Each new exercise will be introduced in easy steps and practiced until the participant is comfortable executing it.
Group II: Reference group without Down syndromeActive Control1 Intervention
This reference group of age- and sex-matched inactive individuals without Down syndrome will undergo the same baseline testing as the other groups but without intervention or post-intervention measures.
Group III: Usual care Down SyndromePlacebo Group1 Intervention
The control condition consists of usual activities.
Find a Location
Who is running the clinical trial?
University of Nevada, Las VegasLead Sponsor
66 Previous Clinical Trials
13,739 Total Patients Enrolled
2 Trials studying Down Syndrome
50 Patients Enrolled for Down Syndrome
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,964 Previous Clinical Trials
2,672,522 Total Patients Enrolled
16 Trials studying Down Syndrome
145,364 Patients Enrolled for Down Syndrome
Thessa Hilgenkamp, PhDPrincipal InvestigatorUniversity of Nevada, Las Vegas
1 Previous Clinical Trials
21 Total Patients Enrolled
1 Trials studying Down Syndrome
21 Patients Enrolled for Down Syndrome
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have high blood pressure (defined as blood pressure higher than 140/90 mmHg).I have Down syndrome with normal or stable thyroid function for at least 6 months.You are extremely overweight with a body mass index (BMI) over 40.Your blood pressure is lower than 90/60 mmHg.I have diabetes with an HbA1c over 7.5% or I am on medication to lower my blood sugar.I do less than 30 minutes of moderate exercise daily.I have a condition related to hardening of the arteries.I am currently taking anti-inflammatory medication.I have asthma or another lung condition.I have a history of fainting or nearly fainting.I was born with a heart condition.You are currently smoking.I am not on medications that affect my heart rate, blood pressure, or arteries.
Research Study Groups:
This trial has the following groups:- Group 1: Reference group without Down syndrome
- Group 2: Combined exercise intervention Down syndrome
- Group 3: Usual care Down Syndrome
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the patient base of this trial limited to those who are 25 and over?
"This trial has restricted its patient intake to individuals aged 18-35, as indicated by the participating requirements."
Answered by AI
Who qualifies to partake in this research endeavor?
"This trial is searching for 60 participants aged 18-35 years old with Down syndrome. The chosen recruits must be inactive (less than 30 minutes of moderately-intense physical activity per day), generally well, correctly diagnosed as trisomy 21 carriers and have a normal or stable thyroid function (and medications) over the course of 6 months."
Answered by AI
Does this research endeavor have any vacancies for participants?
"Indeed, as per information found on clinicaltrials.gov, this medical trial is presently seeking participants. It was initially posted in September 2021 and subsequently revised in October of the same year. Sixty individuals need to be recruited from one specified location."
Answered by AI
How many volunteers are participating in this experiment?
"Absolutely, the information available on clinicaltrials.gov attests to this trial actively seeking participants. It was first publicised on September 9th 2021 and most recently augmented October 6th 2021. At present, 60 individuals are needed at a single medical centre for enrollment purposes."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger