Trial Outcomes & Findings for Blood Flow Regulation in Individuals With Down Syndrome

Results Overview

Change in work capacity from baseline to 13 weeks, as measured by peak oxygen uptake in ml/kg/min with a graded exercise test on a treadmill.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

60 participants

Primary outcome timeframe

13 weeks

Results posted on

2026-02-04

Participant Flow

Recruitment of individuals with Down syndrome occurred through flyers and newsletters spread on campus and in support groups, day programs and organizations for individuals with Down syndrome. All communication, including electronic communication and social media, was only used to spread information about the study. All individuals interested in this study (or their caregivers) were asked to initiate contact with the study team for further information about the study and eligibility screening.

No significant events occurred between the enrollment and assignment of participants to an arm or group.

Participant milestones

Participant milestones
Measure	Combined Exercise Intervention Down Syndrome 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.	Usual Care Down Syndrome The control condition consists of usual activities.	Reference Group Without Down Syndrome 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.
Overall Study STARTED	20	20	20
Overall Study COMPLETED	19	19	20
Overall Study NOT COMPLETED	1	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Combined Exercise Intervention Down Syndrome 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.	Usual Care Down Syndrome The control condition consists of usual activities.	Reference Group Without Down Syndrome 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.
Overall Study Lost to Follow-up	1	1	0

Baseline Characteristics

Blood Flow Regulation in Individuals With Down Syndrome - Training Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Combined Exercise Intervention Down Syndrome n=20 Participants 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.	Usual Care Down Syndrome n=20 Participants The control condition consists of usual activities.	Reference Group Without Down Syndrome n=20 Participants 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.	Total n=60 Participants Total of all reporting groups
Age, Continuous	25.70 Years STANDARD_DEVIATION 3.92 • n=25 Participants	25.55 Years STANDARD_DEVIATION 4.67 • n=26 Participants	23.1 Years STANDARD_DEVIATION 3.34 • n=51 Participants	24.78 Years STANDARD_DEVIATION 4.13 • n=8 Participants
Sex: Female, Male Female	12 Participants n=25 Participants	11 Participants n=26 Participants	16 Participants n=51 Participants	39 Participants n=8 Participants
Sex: Female, Male Male	8 Participants n=25 Participants	9 Participants n=26 Participants	4 Participants n=51 Participants	21 Participants n=8 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=25 Participants	0 Participants n=26 Participants	0 Participants n=51 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Asian	3 Participants n=25 Participants	2 Participants n=26 Participants	10 Participants n=51 Participants	15 Participants n=8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=25 Participants	0 Participants n=26 Participants	0 Participants n=51 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Black or African American	1 Participants n=25 Participants	1 Participants n=26 Participants	1 Participants n=51 Participants	3 Participants n=8 Participants
Race (NIH/OMB) White	14 Participants n=25 Participants	13 Participants n=26 Participants	3 Participants n=51 Participants	30 Participants n=8 Participants
Race (NIH/OMB) More than one race	1 Participants n=25 Participants	2 Participants n=26 Participants	2 Participants n=51 Participants	5 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=25 Participants	2 Participants n=26 Participants	4 Participants n=51 Participants	7 Participants n=8 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=25 Participants	2 Participants n=26 Participants	5 Participants n=51 Participants	8 Participants n=8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	19 Participants n=25 Participants	18 Participants n=26 Participants	14 Participants n=51 Participants	51 Participants n=8 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=25 Participants	0 Participants n=26 Participants	1 Participants n=51 Participants	1 Participants n=8 Participants
Weight	75.82 kg STANDARD_DEVIATION 18.25 • n=25 Participants	71.75 kg STANDARD_DEVIATION 19.02 • n=26 Participants	67.13 kg STANDARD_DEVIATION 15.96 • n=51 Participants	71.56 kg STANDARD_DEVIATION 17.85 • n=8 Participants

PRIMARY outcome

Timeframe: 13 weeks

Population: No post data collection for reference group without Down syndrome. Exercise group DS: 4 participants excluded due to not compliant with exercise group requirements of 20 minutes at 65%HR or higher, additional 2 participants with missing data. Usual care group DS: 3 participant excluded due to \>100% increase in physical activity and being classified in the highest IPAQ physical activity category at post data collection compared to lowest category at baseline, plus 2 participants with missing data

Change in work capacity from baseline to 13 weeks, as measured by peak oxygen uptake in ml/kg/min with a graded exercise test on a treadmill.

Outcome measures

Outcome measures
Measure	Reference Group Without Down Syndrome 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.	Combined Exercise Intervention Down Syndrome n=13 Participants 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.	Usual Care Down Syndrome n=14 Participants The control condition consists of usual activities.
Change From Baseline Work Capacity at 13 Weeks	—	-1.20 change in ml/kg/min Standard Deviation 6.89	-0.18 change in ml/kg/min Standard Deviation 6.89

SECONDARY outcome

Timeframe: 13 weeks

Population: No post data collection for reference group without Down syndrome. Exercise group DS: 4 participants excluded due to not compliant with exercise group requirements of 20 minutes at 65%HR or higher. Usual care group DS: 3 participant excluded due to \>100% increase in physical activity and being classified in the highest IPAQ physical activity category at post data collection compared to lowest category at baseline, additionally 5 participants with missing data.

Forearm blood flow and vascular conductance was measured in both the exercising and non-exercising arm using high definition ultrasound (Alpha 7, Aloka-Hitachi). The brachial artery was imaged in dual mode allowing for simultaneous determination of artery diameter (B-mode) and flow velocity (Doppler mode). Blood flow was determined from the following formula: Forearm Blood flow = (Mean blood velocity) x (Brachial Cross Sectional Area) x (60) and expressed as ml/min. Change from baseline to 13 weeks was presented.

Outcome measures

Outcome measures
Measure	Reference Group Without Down Syndrome 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.	Combined Exercise Intervention Down Syndrome n=15 Participants 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.	Usual Care Down Syndrome n=11 Participants The control condition consists of usual activities.
Change From Baseline Brachial Blood Flow at 13 Weeks	—	24.66 Change in ml/min Standard Deviation 77.57	-15.87 Change in ml/min Standard Deviation 77.57

SECONDARY outcome

Timeframe: 13 weeks

Population: No post data collection for reference group without Down syndrome. Exercise group DS: 4 participants excluded due to not compliant with exercise group requirements of 20 minutes at 65%HR or higher, plus n=5 with missing data. Usual care group DS: 3 participant excluded due to \>100% increase in physical activity and being classified in the highest IPAQ physical activity category at post data collection compared to lowest category at baseline, additionally 8 participants with missing data.

Muscle oxygenation was measured with near-infrared spectrography (NIRS), which is a simple, noninvasive method for measuring the presence of oxygen in muscle. It monitored changes in muscle oxygenation and blood flow during submaximal and maximal exercise. During exercise, the extent to which skeletal muscles deoxygenate varies according to the type of muscle, type of exercise and blood flow response. We analyzed the change from baseline to 13 weeks in percentage of oxygenated blood during hand grip exercise at 30% of maximal voluntary contraction (HGE 30%MVC).

Outcome measures

Outcome measures
Measure	Reference Group Without Down Syndrome 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.	Combined Exercise Intervention Down Syndrome n=10 Participants 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.	Usual Care Down Syndrome n=7 Participants The control condition consists of usual activities.
Change From Baseline Muscle Oxygenation at 13 Weeks	—	-5.27 Change % of oxygenated blood Standard Deviation 12.36	0.49 Change % of oxygenated blood Standard Deviation 4.03

SECONDARY outcome

Timeframe: 13 weeks

Population: No post data collection for reference group without Down syndrome. This was a challenging measurement, and valid data at both pre and post was only obtained for n=2 in the exercise group and n=2 in the control group.

Change from baseline to 13 weeks in cardiac output will be measured during a graded maximal test protocol. The ascending aortic blood flow will be measured using continuous Doppler echocardiography using a pedoff probe in the suprasternal notch.

Outcome measures

Outcome measures
Measure	Reference Group Without Down Syndrome 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.	Combined Exercise Intervention Down Syndrome n=2 Participants 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.	Usual Care Down Syndrome n=2 Participants The control condition consists of usual activities.
Change From Baseline Cardiac Output (Aortic Blood Flow) at 13 Weeks	—	4.26 Change in ml Interval 1.24 to 7.28	0.84 Change in ml Interval 0.57 to 1.12

SECONDARY outcome

Timeframe: 13 weeks

Population: No post data collection for reference group without Down syndrome. Exercise group DS: 4 participants excluded due to not compliant with exercise group requirements of 20 minutes at 65%HR or higher, plus n=5 with missing data. Usual care group DS: 3 participant excluded due to \>100% increase in physical activity and being classified in the highest IPAQ physical activity category at post data collection compared to lowest category at baseline, additionally 8 participants with missing data.

Change from baseline to 13 weeks in clinical autonomic function test: heart rate variability during rest measured in root mean square of successive differences (RMSSD) in ms.

Outcome measures

Outcome measures
Measure	Reference Group Without Down Syndrome 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.	Combined Exercise Intervention Down Syndrome n=10 Participants 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.	Usual Care Down Syndrome n=7 Participants The control condition consists of usual activities.
Change From Baseline Autonomic Cardiac Function at Rest at 13 Weeks	—	-7.40 Change in ms Standard Deviation 18.52	3.71 Change in ms Standard Deviation 13.65

SECONDARY outcome

Timeframe: 13 weeks

Population: No post data collection for reference group without Down syndrome. Exercise group DS: 4 participants excluded due to not compliant with exercise group requirements of 20 minutes at 65%HR or higher, plus n=5 with missing data. Usual care group DS: 3 participant excluded due to \>100% increase in physical activity and being classified in the highest IPAQ physical activity category at post data collection compared to lowest category at baseline, additionally 9 participants with missing data.

Change from baseline to 13 weeks in clinical autonomic function test: heart rate variability during orthostasis in root mean square of successive differences (RMSSD) in ms

Outcome measures

Outcome measures
Measure	Reference Group Without Down Syndrome 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.	Combined Exercise Intervention Down Syndrome n=9 Participants 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.	Usual Care Down Syndrome n=7 Participants The control condition consists of usual activities.
Change From Baseline Autonomic Cardiac Function During Orthostasis at 13 Weeks	—	20.33 Change in ms Standard Deviation 26.34	-4.43 Change in ms Standard Deviation 14.47

SECONDARY outcome

Timeframe: 13 weeks

Population: No post data collection for reference group without Down syndrome. Exercise group DS: 4 participants excluded due to not compliant with exercise group requirements of 20 minutes at 65%HR or higher, plus n=3 with missing data. Usual care group DS: 3 participant excluded due to \>100% increase in physical activity and being classified in the highest IPAQ physical activity category at post data collection compared to lowest category at baseline, additionally 5 participants with missing data.

Change from baseline to 13 weeks for interleukin-6 IL-6 (venous blood sample)

Outcome measures

Outcome measures
Measure	Reference Group Without Down Syndrome 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.	Combined Exercise Intervention Down Syndrome n=12 Participants 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.	Usual Care Down Syndrome n=11 Participants The control condition consists of usual activities.
Change From Baseline IL-6 at 13 Weeks	—	-0.75 Change in pg/mL Standard Deviation 2.30	3.28 Change in pg/mL Standard Deviation 9.22

SECONDARY outcome

Timeframe: 13 weeks

Population: No post data collection for reference group without Down syndrome. Exercise group DS: 4 participants excluded due to not compliant with exercise group requirements of 20 minutes at 65%HR or higher, additional 3 participants with missing data. Usual care group DS: 3 participant excluded due to \>100% increase in physical activity and being classified in the highest IPAQ physical activity category at post data collection compared to lowest category at baseline, plus 3 participants with missing data

Change from Baseline in High-Density Lipoprotein in venous blood sample

Outcome measures

Outcome measures
Measure	Reference Group Without Down Syndrome 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.	Combined Exercise Intervention Down Syndrome n=12 Participants 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.	Usual Care Down Syndrome n=13 Participants The control condition consists of usual activities.
Change From Baseline HDL at 13 Weeks	—	-3.67 Change in mg/dL Standard Deviation 7.46	-2.31 Change in mg/dL Standard Deviation 10.04

SECONDARY outcome

Timeframe: 13 weeks

Population: No post data collection for reference group without Down syndrome. Exercise group DS: 4 participants excluded due to not compliant with exercise group requirements of 20 minutes at 65%HR or higher, additional 1 participant with missing data. Usual care group DS: 3 participant excluded due to \>100% increase in physical activity and being classified in the highest IPAQ physical activity category at post data collection compared to lowest category at baseline, plus 1 participant with missing data

Change from Baseline to 13 weeks in super oxide dismutase (venous blood sample)

Outcome measures

Outcome measures
Measure	Reference Group Without Down Syndrome 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.	Combined Exercise Intervention Down Syndrome n=14 Participants 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.	Usual Care Down Syndrome n=15 Participants The control condition consists of usual activities.
Change From Baseline Superoxide Dismutase at 13 Weeks	—	-0.5510 Change in pg/mL Standard Deviation 2.42	-0.1576 Change in pg/mL Standard Deviation 0.8743

SECONDARY outcome

Timeframe: 13 weeks

Population: No post data collection for reference group without Down syndrome. Exercise group DS: 4 participants excluded due to not compliant with exercise group requirements of 20 minutes at 65%HR or higher, additional 4 participants with missing data. Usual care group DS: 3 participant excluded due to \>100% increase in physical activity and being classified in the highest IPAQ physical activity category at post data collection compared to lowest category at baseline, plus 6 participants with missing data

Change from Baseline to 13 weeks in Comfortable walking speed in cm/sec

Outcome measures

Outcome measures
Measure	Reference Group Without Down Syndrome 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.	Combined Exercise Intervention Down Syndrome n=12 Participants 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.	Usual Care Down Syndrome n=10 Participants The control condition consists of usual activities.
Change From Baseline Comfortable Walking Speed at 13 Weeks	—	5.49 Change in cm/sec Standard Deviation 14.98	1.27 Change in cm/sec Standard Deviation 18.31

SECONDARY outcome

Timeframe: 13 weeks

Population: No post data collection for reference group without Down syndrome. Exercise group DS: 4 participants excluded due to not compliant with exercise group requirements of 20 minutes at 65%HR or higher, additional 3 participants with missing data. Usual care group DS: 3 participant excluded due to \>100% increase in physical activity and being classified in the highest IPAQ physical activity category at post data collection compared to lowest category at baseline, plus 6 participants with missing data

Change from Baseline to 13 weeks in Fast Walking Speed in cm/sec

Outcome measures

Outcome measures
Measure	Reference Group Without Down Syndrome 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.	Combined Exercise Intervention Down Syndrome n=12 Participants 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.	Usual Care Down Syndrome n=10 Participants The control condition consists of usual activities.
Change From Baseline Fast Walking Speed at 13 Weeks	—	6.96 Change in cm/sec Standard Deviation 19.99	-1.93 Change in cm/sec Standard Deviation 19.52

SECONDARY outcome

Timeframe: 13 weeks

Population: No post data collection for reference group without Down syndrome. Exercise group DS: 4 participants excluded due to not compliant with exercise group requirements of 20 minutes at 65%HR or higher, additional 3 participants with missing data. Usual care group DS: 3 participant excluded due to \>100% increase in physical activity and being classified in the highest IPAQ physical activity category at post data collection compared to lowest category at baseline, plus 1 participant with missing data

Change from baseline to 13 week in Functional Reach, which is a balance test to investigate how far the participant can reach measured in cm.

Outcome measures

Outcome measures
Measure	Reference Group Without Down Syndrome 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.	Combined Exercise Intervention Down Syndrome n=12 Participants 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.	Usual Care Down Syndrome n=15 Participants The control condition consists of usual activities.
Change From Baseline Functional Reach at 13 Weeks	—	-0.82 Change in cm Standard Deviation 2.26	0.17 Change in cm Standard Deviation 2.41

SECONDARY outcome

Timeframe: 13 weeks

Population: No post data collection for reference group without Down syndrome. Exercise group DS: 4 participants excluded due to not compliant with exercise group requirements of 20 minutes at 65%HR or higher. Usual care group DS: 3 participant excluded due to \>100% increase in physical activity and being classified in the highest IPAQ physical activity category at post data collection compared to lowest category at baseline, plus 1 participants with missing data

Timed Up and Go is a dynamic balance test involving getting up from a chair, walk around a mark and sit back down, the time in sec to complete whole sequence is the outcome. Change was measured from baseline to 13 weeks.

Outcome measures

Outcome measures
Measure	Reference Group Without Down Syndrome 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.	Combined Exercise Intervention Down Syndrome n=15 Participants 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.	Usual Care Down Syndrome n=15 Participants The control condition consists of usual activities.
Change From Baseline Timed Up and Go at 13 Weeks	—	-0.59 Change in seconds Standard Deviation 1.56	-0.34 Change in seconds Standard Deviation 2.34

SECONDARY outcome

Timeframe: 13 weeks

Population: No post data collection for reference group without Down syndrome. Exercise group DS: 4 participants excluded due to not compliant with exercise group requirements of 20 minutes at 65%HR or higher, additional 2 participants with missing data. Usual care group DS: 3 participant excluded due to \>100% increase in physical activity and being classified in the highest IPAQ physical activity category at post data collection compared to lowest category at baseline, plus 2 participants with missing data

The Sensory Organization Test of the Bertec Balance System was used to detect balance problems with standing under different conditions. The purpose of the Sensory Organization Test is to systematically evaluate the components of the balance control system, including the vision, vestibular, and somatosensory systems in order to identify possible abnormalities in these systems. The Sensory Organization Test has 6 separate conditions varying in eyes open/closed, fixed or moving visual environment and fixed or moving support surface. This test provides a quantitative evaluation of the person's sway during the 6 conditions, presented as equilibrium score from 0-100 for each condition, with higher scores representing better equilibrium. The composite score is the average equilibrium score of the six conditions.

Outcome measures

Outcome measures
Measure	Reference Group Without Down Syndrome 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.	Combined Exercise Intervention Down Syndrome n=13 Participants 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.	Usual Care Down Syndrome n=14 Participants The control condition consists of usual activities.
Change From Baseline Standing Balance at 13 Weeks	—	1.11 Change in Composite score Standard Deviation 6.71	-3.39 Change in Composite score Standard Deviation 9.25

OTHER_PRE_SPECIFIED outcome

Timeframe: 13 weeks

Population: No post data collection for reference group without Down syndrome. Exercise group DS: 4 participants excluded due to not compliant with exercise group requirements of 20 minutes at 65%HR or higher, additional 1 participant with missing data. Usual care group DS: 3 participant excluded due to \>100% increase in physical activity and being classified in the highest IPAQ physical activity category at post data collection compared to lowest category at baseline, plus 2 participants with missing data

Change from Baseline to 13 weeks in C-Reactive Protein (CRP) in pg/mL (venous blood sample)

Outcome measures

Outcome measures
Measure	Reference Group Without Down Syndrome 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.	Combined Exercise Intervention Down Syndrome n=14 Participants 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.	Usual Care Down Syndrome n=14 Participants The control condition consists of usual activities.
Change From Baseline C-Reactive Protein at 13 Weeks	—	-860792 Change in pg/mL Standard Deviation 1614281	457370 Change in pg/mL Standard Deviation 953205

OTHER_PRE_SPECIFIED outcome

Timeframe: 13 weeks

Population: No post data collection for reference group without Down syndrome. Exercise group DS: 4 participants excluded due to not compliant with exercise group requirements of 20 minutes at 65%HR or higher, additional 2 participants with missing data. Usual care group DS: 3 participant excluded due to \>100% increase in physical activity and being classified in the highest IPAQ physical activity category at post data collection compared to lowest category at baseline, plus 3 participants with missing data

Change from Baseline to 13 weeks in Tumor Necrosis Factor - alpha (TNF-alpha) in pg/mL (venous blood sample)

Outcome measures

Outcome measures
Measure	Reference Group Without Down Syndrome 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.	Combined Exercise Intervention Down Syndrome n=13 Participants 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.	Usual Care Down Syndrome n=13 Participants The control condition consists of usual activities.
Change From Baseline Tumor Necrosis Factor - Alpha at 13 Weeks	—	-1.1142 Change in pg/mL Standard Deviation 2.28008	1.1892 Change in pg/mL Standard Deviation 2.98976

OTHER_PRE_SPECIFIED outcome

Timeframe: 13 weeks

Population: No post data collection for reference group without Down syndrome. Exercise group DS: 4 participants excluded due to not compliant with exercise group requirements of 20 minutes at 65%HR or higher, additional 3 participants with missing data. Usual care group DS: 3 participant excluded due to \>100% increase in physical activity and being classified in the highest IPAQ physical activity category at post data collection compared to lowest category at baseline, plus 2 participants with missing data

Change from Baseline to 13 weeks in Glucose in mg/dL (venous blood sample)

Outcome measures

Outcome measures
Measure	Reference Group Without Down Syndrome 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.	Combined Exercise Intervention Down Syndrome n=12 Participants 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.	Usual Care Down Syndrome n=14 Participants The control condition consists of usual activities.
Change From Baseline Glucose at 13 Weeks	—	1.41 Change in mg/dL Standard Deviation 16.00	-0.21 Change in mg/dL Standard Deviation 9.36

OTHER_PRE_SPECIFIED outcome

Timeframe: 13 weeks

Population: No post data collection for reference group without Down syndrome. Exercise group DS: 4 participants excluded due to not compliant with exercise group requirements of 20 minutes at 65%HR or higher, additional 1 participant with missing data. Usual care group DS: 3 participant excluded due to \>100% increase in physical activity and being classified in the highest IPAQ physical activity category at post data collection compared to lowest category at baseline, plus 2 participants with missing data.

Change from Baseline to 13 weeks in Leptin in pg/mL (venous blood sample)

Outcome measures

Outcome measures
Measure	Reference Group Without Down Syndrome 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.	Combined Exercise Intervention Down Syndrome n=14 Participants 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.	Usual Care Down Syndrome n=14 Participants The control condition consists of usual activities.
Change From Baseline Leptin at 13 Weeks	—	-24203 Change in pg/mL Standard Deviation 30074	-6216 Change in pg/mL Standard Deviation 37238

POST_HOC outcome

Timeframe: 13 weeks

Population: No post data collection for reference group without Down syndrome. Exercise group DS: 4 participants excluded due to not compliant with exercise group requirements of 20 minutes at 65%HR or higher. Usual care group DS: 3 participant excluded due to \>100% increase in physical activity and being classified in the highest IPAQ physical activity category at post data collection compared to lowest category at baseline, plus 1 participant with missing data.

Change from Baseline to 13 weeks in 2-Minute-Step Test in numbers of steps

Outcome measures

Outcome measures
Measure	Reference Group Without Down Syndrome 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.	Combined Exercise Intervention Down Syndrome n=15 Participants 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.	Usual Care Down Syndrome n=15 Participants The control condition consists of usual activities.
Change From Baseline 2-Minute-Step Test (2MST) at 13 Weeks	—	25.47 Change in number of steps Standard Deviation 18.16	12.6 Change in number of steps Standard Deviation 14.09

POST_HOC outcome

Timeframe: 13 weeks

Population: No post data collection for reference group without Down syndrome. Exercise group DS: 4 participants excluded due to not compliant with exercise group requirements of 20 minutes at 65%HR or higher. Usual care group DS: 3 participant excluded due to \>100% increase in physical activity and being classified in the highest IPAQ physical activity category at post data collection compared to lowest category at baseline.

Change from Baseline to 13 weeks in Weight in kg

Outcome measures

Outcome measures
Measure	Reference Group Without Down Syndrome 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.	Combined Exercise Intervention Down Syndrome n=15 Participants 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.	Usual Care Down Syndrome n=16 Participants The control condition consists of usual activities.
Change From Baseline Weight at 13 Weeks	—	-0.93 Change in kg Standard Deviation 2.18	-0.0312 Change in kg Standard Deviation 1.51

POST_HOC outcome

Timeframe: 13 weeks

Population: No post data collection for reference group without Down syndrome. Exercise group DS: 4 participants excluded due to not compliant with exercise group requirements of 20 minutes at 65%HR or higher, additional 1 participant with missing data. Usual care group DS: 3 participant excluded due to \>100% increase in physical activity and being classified in the highest IPAQ physical activity category at post data collection compared to lowest category at baseline, plus 2 participants with missing data.

Change from Baseline to 13 weeks in Waist Circumference in cm

Outcome measures

Outcome measures
Measure	Reference Group Without Down Syndrome 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.	Combined Exercise Intervention Down Syndrome n=14 Participants 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.	Usual Care Down Syndrome n=14 Participants The control condition consists of usual activities.
Change From Baseline Waist Circumference at 13 Weeks	—	-1.43 Change in cm Standard Deviation 3.44	1.71 Change in cm Standard Deviation 3.98

POST_HOC outcome

Timeframe: 13 weeks

Population: No post data collection for reference group without Down syndrome. Exercise group DS: 4 participants excluded due to not compliant with exercise group requirements of 20 minutes at 65%HR or higher. Usual care group DS: 3 participant excluded due to \>100% increase in physical activity and being classified in the highest IPAQ physical activity category at post data collection compared to lowest category at baseline.

Change from Baseline to 13 weeks in BMI in kg/m2

Outcome measures

Outcome measures
Measure	Reference Group Without Down Syndrome 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.	Combined Exercise Intervention Down Syndrome n=15 Participants 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.	Usual Care Down Syndrome n=16 Participants The control condition consists of usual activities.
Change From Baseline BMI at 13 Weeks	—	-0.38 Change in kg/m2 Standard Deviation 1.06	0.15 Change in kg/m2 Standard Deviation 1.00

Adverse Events

Combined Exercise Intervention Down Syndrome

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Care Down Syndrome

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Reference Group Without Down Syndrome

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Thessa Hilgenkamp

University of Nevada, Las Vegas

Phone: 702-895-1055

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Trial Outcomes & Findings for Blood Flow Regulation in Individuals With Down Syndrome - Training Study (NCT NCT04854122)

Results Overview

Participant Flow

Participant milestones

Reasons for withdrawal

Baseline Characteristics

Baseline characteristics by cohort

PRIMARY outcome

Outcome measures

SECONDARY outcome

Outcome measures

SECONDARY outcome

Outcome measures

SECONDARY outcome

Outcome measures

SECONDARY outcome

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SECONDARY outcome

Outcome measures

SECONDARY outcome

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SECONDARY outcome

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SECONDARY outcome

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SECONDARY outcome

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SECONDARY outcome

Outcome measures

SECONDARY outcome

Outcome measures

SECONDARY outcome

Outcome measures

SECONDARY outcome

Outcome measures

OTHER_PRE_SPECIFIED outcome

Outcome measures

OTHER_PRE_SPECIFIED outcome

Outcome measures

OTHER_PRE_SPECIFIED outcome

Outcome measures

OTHER_PRE_SPECIFIED outcome

Outcome measures

POST_HOC outcome

Outcome measures

POST_HOC outcome

Outcome measures

POST_HOC outcome

Outcome measures

POST_HOC outcome

Outcome measures

Adverse Events

Combined Exercise Intervention Down Syndrome

Usual Care Down Syndrome

Reference Group Without Down Syndrome

Serious adverse events

Other adverse events

Additional Information

Thessa Hilgenkamp

Results disclosure agreements