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NCT05518136

Evaluations of Cardiopulmonary Function and Motor Development of Congenital Heart Disease

Completed NA Last updated 26 August 2022
What this trial tests

NA trial testing exercise-guidance on rehab APP in Congenital Heart Disease in Children in 28 participants. Completed in 25 May 2022.

Timeline
10 April 2021
Primary endpoint
28 December 2021
25 May 2022

Quick facts

Lead sponsorGejingwa Zhao
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposesupportive care
Enrollment28
Start date10 April 2021
Primary completion28 December 2021
Estimated completion25 May 2022
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Gejingwa Zhao

Who can join

Adults 4 Months to 8 Months, any sex, with Congenital Heart Disease in Children or Infant Development. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Cellphone application rehabilitation management and evaluations of cardiopulmonary function and motor development in infants with congenital heart disease: a pilot study.
    Zhao GJ, Li ZQ, Ma Y, Zhu YB, et al · · 2023 · PMID 37285015 · DOI 10.1007/s12519-023-00734-6

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