NCT03590665

Brief Summary

This study focuses on physiological explanations of difficulties with physical activity and exercise in individuals with Down syndrome, by non-invasively examining cardiac output and the regulation of blood flow to working muscles during exercise.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 21, 2018

Completed
27 days until next milestone

First Posted

Study publicly available on registry

July 18, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 8, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 8, 2019

Completed
Last Updated

July 15, 2019

Status Verified

July 1, 2019

Enrollment Period

1.2 years

First QC Date

June 21, 2018

Last Update Submit

July 11, 2019

Conditions

Down Syndrome

Keywords

exercise, blood flow, strength, blood pressure, heart rate,

Outcome Measures

Primary Outcomes (1)

  • Brachial blood flow

    Forearm blood flow and vascular conductance will be measured in both the exercising and non-exercising arm using high definition ultrasound (Alpha 7, Aloka-Hitachi). The brachial artery will be imaged in dual mode allowing for simultaneous determination of artery diameter (B-mode) and flow velocity (Doppler mode). Blood flow will be determined from the following formula: Forearm Blood flow = (Mean blood velocity) x (Brachial Cross Sectional Area) x (60) and expressed as ml/min. Forearm vascular conductance will be determined by dividing forearm blood flow by mean arterial pressure. Forearm blood flow and vascular conductance will be normalized to forearm lean mass to account for differences in lean mass between individuals.

    In minute 4 of the 5-minute bout of grip strength exercise

Secondary Outcomes (2)

  • Muscle oxygenation

    In minute 4 of the 5-minute bout of grip strength exercise

  • Cardiac outut

    Every second minute until the 12th minute of the maximal test.

Study Arms (2)

Individuals with Down syndrome

OTHER

For participants with Down syndrome, the first visit includes baseline measures and familiarization with the graded maximal exercise test protocol. If necessary, additional familiarization sessions will be scheduled for people with Down syndrome. The second visit, we perform the graded maximal exercise test and familiarize the participant with the procedures for the third visit: the hand grip exercise protocol and the lower body negative pressure (LBNP) box. The third visit we assess the peripheral blood flow during the hand grip exercise protocol without and with the LBNP. For control subjects, the first and second visit are combined. Their second visit is the same as the third visit for individuals with Down syndrome.

Other: Hand grip exercise and lower body negative pressure

Individuals without Down syndrome

OTHER

For participants with Down syndrome, the first visit includes baseline measures and familiarization with the graded maximal exercise test protocol. The second visit, we perform the graded maximal exercise test and familiarize the participant with the procedures for the third visit: the hand grip exercise protocol and the lower body negative pressure (LBNP) box. The third visit we assess the peripheral blood flow during the hand grip exercise protocol without and with the LBNP. For control subjects, the first and second visit are combined. Their second visit is the same as the third visit for individuals with Down syndrome.

Other: Hand grip exercise and lower body negative pressure

Interventions

Hand grip exercise and lower body negative pressureOTHER

For participants with Down syndrome, the first visit includes baseline measures and familiarization with the graded maximal exercise test protocol. If necessary, additional familiarization sessions will be scheduled for people with Down syndrome. The second visit, we perform the graded maximal exercise test and familiarize the participant with the procedures for the third visit: the hand grip exercise protocol and the lower body negative pressure (LBNP) box. The third visit we assess the peripheral blood flow during the hand grip exercise protocol without and with the LBNP. For control subjects, the first and second visit are combined. Their second visit is the same as the third visit for individuals with Down syndrome.

Individuals with Down syndromeIndividuals without Down syndrome

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Between 18 and 45 years old
  • generally healthy
  • sedentary or low-active (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 months.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Disability, Health, and Social Policy Building, Integrative Physiology Laboratory, Suite 158 at 1640 W. Roosevelt Rd

Chicago, Illinois, 60608, United States

Location

MeSH Terms

Conditions

Down SyndromeMotor Activity

Interventions

Lower Body Negative Pressure

Condition Hierarchy (Ancestors)

Intellectual DisabilityNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesChromosome DisordersGenetic Diseases, InbornBehavior

Intervention Hierarchy (Ancestors)

DecompressionTherapeutics

Study Officials

  • Thessa Hilgenkamp, PhD

    University of Illinois at Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Model Details: The acute response to exercise in blood flow is non-invasively assessed in group of individuals with Down syndrome and a control group of age- and sex-matched individuals without Down syndrome.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Postdoctoral fellow

Study Record Dates

First Submitted

June 21, 2018

First Posted

July 18, 2018

Study Start

March 1, 2018

Primary Completion

May 8, 2019

Study Completion

May 8, 2019

Last Updated

July 15, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)