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NCT Number: NCT05518136

Evaluations of Cardiopulmonary Function and Motor Development of Congenital Heart Disease

In this single-center, randomized controlled trial, patients (4-8 months) with CHD were randomly assigned to either a recovery group (home-based rehab exercise periodically) supervised by cellphone APP or to a control group. Left ventricular ejection fractions (LVEF), the rate of increase in heart rate (rHRI), and the rate of recovery heart rate (rHRR) were measured for representing cardiopulmonary capacity. The Alberta test and Neuro-intelligence Scale were used to evaluate their motor developmental outcomes. This study verified the feasibility of this rehab method and indicated that 6-month home-based exercise training can improve cardiopulmonary endurance and motor developmental level in infant CHD patients.

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Key information

Conditions

Congenital Heart Disease in Children Cardiopulmonary Infant Conditions Infant Development Motor Delay Motor Neuropathy Nervous System Diseases Neuritis Neurobehavioral Manifestations Neurologic Manifestations Neuromuscular Diseases Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Psychomotor Disorders Signs and Symptoms

Age range

4 month–8 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Children's Hospital

Beijing, Beijing Municipality, 100000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • CHD infants (aged 4-8 months) with atrial septum defect (ASD) or ventricular septum defect (VSD)

Exclusion criteria

  • chromosomal abnormalities; family history of mental retardation; small for gestational age and prematurity; history of perinatal asphyxia and hyperbilirubinemia; history of central nervous system disease or imaging suggestive of brain dysplasia

Treatment and study plan

exercise-guidance on rehab APP

Behavioral

Training motions included sitting balance, hand support, crawling and squatting training12-14 were scheduled for 1 to 3 months postoperatively, moreover, climbing over obstacles was for 3 to 6 months.

Primary outcomes

  1. Baseline LVEF

    Time frame: pre-operative for baseline assessment

    Left ventricular ejection fraction before surgery

  2. Baseline rHRI

    Time frame: pre-operative for baseline assessment

    The rate of increase in heart rate before surgery

  3. Baseline rHRR

    Time frame: pre-operative for baseline assessment

    The rate of recovery heart rate before surgery

  4. Baseline Alberta score

    Time frame: pre-operative for baseline assessment

    Alberta motor test results before surgery

  5. Baseline Neuro-intelligence Scale

    Time frame: pre-operative for baseline assessment

    Developmental Quotient (DQ) before surgery

  6. LVEF one month after the surgery

    Time frame: one month after surgery

    Left ventricular ejection fraction one month after the surgery

  7. rHRI one month after the surgery rHRI one month after the surgery

    Time frame: one month after surgery

    The rate of increase in heart rate one month after the surgery

  8. rHRR one month after the surgery

    Time frame: one month after surgery

    The rate of recovery heart rate one month after the surgery

  9. Alberta score one month after the surgery

    Time frame: one month after surgery

    Alberta motor test results one month after the surgery

  10. Neuro-intelligence Scale one month after the surgery

    Time frame: one month after surgery

    Developmental Quotient (DQ) one month after the surgery

  11. LVEF three months after the surgery

    Time frame: three months after surgery

    Left ventricular ejection fraction three months after the surgery

  12. rHRI three months after the surgery

    Time frame: three months after surgery

    The rate of increase in heart rate three months after the surgery

  13. rHRR three months after the surgery

    Time frame: three months after surgery

    The rate of recovery heart rate three months after the surgery

  14. Alberta score three months after the surgery

    Time frame: three months after surgery

    Alberta motor test results three months after the surgery

  15. Neuro-intelligence Scale three months after the surgery

    Time frame: three months after surgery

    Developmental Quotient (DQ) three months after the surgery

  16. LVEF six months after the surgery

    Time frame: six months after surgery

    Left ventricular ejection fraction six months after the surgery

  17. rHRI six months after the surgery

    Time frame: six months after surgery

    The rate of increase in heart rate six months after the surgery

  18. rHRR six months after the surgery

    Time frame: six months after surgery

    The rate of recovery heart rate six months after the surgery

  19. Alberta score six months after the surgery

    Time frame: six months after surgery

    Alberta motor test results six months after the surgery

  20. Neuro-intelligence Scale six months after the surgery

    Time frame: six months after surgery

    Developmental Quotient (DQ) six months after the surgery

Sponsors and collaborators

Lead sponsor

Gejingwa Zhao

Other

Registry information

Official study title

APP Rehabilitation Management and Evaluations of Cardiopulmonary Function and Motor Development in Infants With Congenital Heart Disease: a Pilot Study

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Aug 26, 2022
Registry last updated
Aug 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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