Congenital Heart Disease in ChildrenNCT05518136
Evaluations of Cardiopulmonary Function and Motor Development of Congenital Heart Disease
A study testing exercise-guidance on rehab APP in people with Congenital Heart Disease in Children and Infant Development, run by Gejingwa Zhao at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 4 to 8 months
- Conditions the study is for
- Congenital Heart Disease in Children, Infant Development, Infant Conditions
- What is being tested?
- exercise-guidance on rehab APP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteChina
- Study dates
- 10 Apr 2021to 25 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 8 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- CHD infants (aged 4-8 months) with atrial septum defect (ASD) or ventricular septum defect (VSD)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: APP Rehabilitation Management and Evaluations of Cardiopulmonary Function and Motor Development in Infants With Congenital Heart Disease: a Pilot Study
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.
- Conditions
- Congenital Heart Disease in Children, Infant Development, Infant Conditions, Motor Neuropathy, Motor Delay, Cardiopulmonary
- Being tested
- exercise-guidance on rehab APP
- Keywords
- infant, rehab management APP, home-based exercise, cardiopulmonary endurance, motor developmental level
- Medical subject headings
- Neuritis, Psychomotor Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise-guidance on rehab APPBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Recovery group | Experimental | Recovery group was given home-based rehab exercise periodically supervised by cellphone APP. 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. Receives: Behavioral: exercise-guidance on rehab APP |
| Control group | No intervention | General post-operative care for 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline LVEF
Left ventricular ejection fraction before surgery
Measured: pre-operative for baseline assessment
Baseline rHRI
The rate of increase in heart rate before surgery
Measured: pre-operative for baseline assessment
Baseline rHRR
The rate of recovery heart rate before surgery
Measured: pre-operative for baseline assessment
Baseline Alberta score
Alberta motor test results before surgery
Measured: pre-operative for baseline assessment
Baseline Neuro-intelligence Scale
Developmental Quotient (DQ) before surgery
Measured: pre-operative for baseline assessment
LVEF one month after the surgery
Left ventricular ejection fraction one month after the surgery
Measured: one month after surgery
rHRI one month after the surgery rHRI one month after the surgery
The rate of increase in heart rate one month after the surgery
Measured: one month after surgery
rHRR one month after the surgery
The rate of recovery heart rate one month after the surgery
Measured: one month after surgery
Alberta score one month after the surgery
Alberta motor test results one month after the surgery
Measured: one month after surgery
Neuro-intelligence Scale one month after the surgery
Developmental Quotient (DQ) one month after the surgery
Measured: one month after surgery
LVEF three months after the surgery
Left ventricular ejection fraction three months after the surgery
Measured: three months after surgery
rHRI three months after the surgery
The rate of increase in heart rate three months after the surgery
Measured: three months after surgery
rHRR three months after the surgery
The rate of recovery heart rate three months after the surgery
Measured: three months after surgery
Alberta score three months after the surgery
Alberta motor test results three months after the surgery
Measured: three months after surgery
Neuro-intelligence Scale three months after the surgery
Developmental Quotient (DQ) three months after the surgery
Measured: three months after surgery
LVEF six months after the surgery
Left ventricular ejection fraction six months after the surgery
Measured: six months after surgery
rHRI six months after the surgery
The rate of increase in heart rate six months after the surgery
Measured: six months after surgery
rHRR six months after the surgery
The rate of recovery heart rate six months after the surgery
Measured: six months after surgery
Alberta score six months after the surgery
Alberta motor test results six months after the surgery
Measured: six months after surgery
Neuro-intelligence Scale six months after the surgery
Developmental Quotient (DQ) six months after the surgery
Measured: six months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2022
- Study start10 Apr 2021
- Primary completion28 Dec 2021
- Study completion25 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Congenital Heart Disease in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gejingwa Zhao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gejingwa Zhao, Beijing Children's Hospital
- Investigators
- Gejingwa Zhao, Principal investigator, Beijing Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05518136
- Sponsor's protocol ID
- Beijing Children's Hospital
- Status last verified
- Aug 2022
- First submitted
- 18 Aug 2022
- Last updated
- 26 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Gurvitz M, Valente AM, Broberg C, Cook S, Stout K, Kay J, Ting J, Kuehl K, Earing M, Webb G, Houser L, Opotowsky A, Harmon A, Graham D, Khairy P, Gianola A, Verstappen A, Landzberg M; Alliance for Adult Research in Congenital Cardiology (AARCC) and Adult Congenital Heart Association. Prevalence and predictors of gaps in care among adult congenital heart disease patients: HEART-ACHD (The Health, Education, and Access Research Trial). J Am Coll Cardiol. 2013 May 28;61(21):2180-4. doi: 10.1016/j.jacc.2013.02.048. Epub 2013 Mar 28.
PubMed 23542112
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- APP Rehabilitation Management and Evaluations of Cardiopulmonary Function and Motor Development in Infants With Congenital Heart Disease: a Pilot Study
- ClinicalTrials.gov ID
- NCT05518136
- Acronym / sponsor ID
- Beijing Children's Hospital
- Conditions
- Congenital Heart Disease in Children, Infant Development, Infant Conditions, Motor Neuropathy, Motor Delay, Cardiopulmonary
- Keywords
- infant, rehab management APP, home-based exercise, cardiopulmonary endurance, motor developmental level
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Gejingwa ZhaoUniversity, hospital or other
- Study start
- 10 Apr 2021 (actual)
- Primary completion
- 28 Dec 2021 (actual)
- Study completion
- 25 May 2022 (actual)
- First posted
- 26 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Recovery group | Experimental | Behavioral: exercise-guidance on rehab APPRecovery group was given home-based rehab exercise periodically supervised by cellphone APP. 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. |
| Control group | No intervention | –General post-operative care for 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. |
Who may qualify
- Ages
- 4 to 8 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- CHD infants (aged 4-8 months) with atrial septum defect (ASD) or ventricular septum defect (VSD)
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exercise-guidance on rehab APPTraining 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. | Behavioural | Recovery group |
Primary outcome
Baseline LVEF
Time frame: pre-operative for baseline assessment
Left ventricular ejection fraction before surgery
Baseline rHRI
Time frame: pre-operative for baseline assessment
The rate of increase in heart rate before surgery
Baseline rHRR
Time frame: pre-operative for baseline assessment
The rate of recovery heart rate before surgery
Baseline Alberta score
Time frame: pre-operative for baseline assessment
Alberta motor test results before surgery
Baseline Neuro-intelligence Scale
Time frame: pre-operative for baseline assessment
Developmental Quotient (DQ) before surgery
LVEF one month after the surgery
Time frame: one month after surgery
Left ventricular ejection fraction one month after the surgery
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
rHRR one month after the surgery
Time frame: one month after surgery
The rate of recovery heart rate one month after the surgery
Alberta score one month after the surgery
Time frame: one month after surgery
Alberta motor test results one month after the surgery
Neuro-intelligence Scale one month after the surgery
Time frame: one month after surgery
Developmental Quotient (DQ) one month after the surgery
LVEF three months after the surgery
Time frame: three months after surgery
Left ventricular ejection fraction three months after the surgery
rHRI three months after the surgery
Time frame: three months after surgery
The rate of increase in heart rate three months after the surgery
rHRR three months after the surgery
Time frame: three months after surgery
The rate of recovery heart rate three months after the surgery
Alberta score three months after the surgery
Time frame: three months after surgery
Alberta motor test results three months after the surgery
Neuro-intelligence Scale three months after the surgery
Time frame: three months after surgery
Developmental Quotient (DQ) three months after the surgery
LVEF six months after the surgery
Time frame: six months after surgery
Left ventricular ejection fraction six months after the surgery
rHRI six months after the surgery
Time frame: six months after surgery
The rate of increase in heart rate six months after the surgery
rHRR six months after the surgery
Time frame: six months after surgery
The rate of recovery heart rate six months after the surgery
Alberta score six months after the surgery
Time frame: six months after surgery
Alberta motor test results six months after the surgery
Neuro-intelligence Scale six months after the surgery
Time frame: six months after surgery
Developmental Quotient (DQ) six months after the surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2022.
- Background: PubMed 23542112Gurvitz M, Valente AM, Broberg C, Cook S, Stout K, Kay J, Ting J, Kuehl K, Earing M, Webb G, Houser L, Opotowsky A, Harmon A, Graham D, Khairy P, Gianola A, Verstappen A, Landzberg M; Alliance for Adult Research in Congenital Cardiology (AARCC) and Adult Congenital Heart Association. Prevalence and predictors of gaps in care among adult congenital heart disease patients: HEART-ACHD (The Health, Education, and Access Research Trial). J Am Coll Cardiol. 2013 May 28;61(21):2180-4. doi: 10.1016/j.jacc.2013.02.048. Epub 2013 Mar 28.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gejingwa Zhao principal investigator
Beijing Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise-guidance on rehab APP in people with Congenital Heart Disease in Children and Infant Development, run by Gejingwa Zhao at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline LVEF (time frame: pre-operative for baseline assessment). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05518136, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2022.