Condition category
Circulatory System
Date applied
09/09/2013
Date assigned
25/10/2013
Last edited
11/06/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
In Northern Ireland lots of babies are born every year with heart problems and following advances in treatment, most of these children are growing up to reach adulthood. Everyone knows that regular exercise and a healthy lifestyle can have benefits but few people get the recommended amount of regular activity each week. We believe that children with heart problems are a group who could benefit from regular exercise. In this study we would like to find out how physical and mental health compares between children with major and minor heart problems. We would like to see if by a motivational program we can encourage them and their families to increase their level of daily activity and make healthier lifestyle choices. We would also like to see if we can show positive benefits on both physical and mental health by increased activity. If this study is successful it will provide a better understanding of how children and their families view their heart problems and provide evidence that regular exercise can have benefits for children with congenital heart disease.

Who can participate?
Patients with congenital heart disease, aged 5-10 years, who attended the participating hospital are invited to take part.

What does the study involve?
Participants will be randomly allocated to one of two groups. One group will be called the intervention group and the other the control group. Both groups will be asked to attend the Department of Paediatric Cardiology at the Royal Belfast Hospital For Sick Children (RBHSC) for assessment. This will involve taking measurements such as height, weight and BMI (body mass index). Participants will be given an exercise bike test. They will be asked to complete a diary of their diet and some questionnaires about how they view their heart condition. These tests will be arranged by the research doctor and a specialist in psychology. They will also be available to answer any questions about the study. Participants will be asked to return to the Department of Paediatric Cardiology at RBHSC to collect an activity monitor to wear as part of the assessment. This is like a pedometer and measures the amount of activity done. They will be asked to wear this for one week. Those participants in the intervention group only will then be asked to attend the Department of Paediatric Cardiology at RBHSC for an education session. During this session they will be given advice about healthy diet and lifestyle. They will also be given some information to take home. At this stage the participants will be seen by the research doctor who will suggest some exercises that would be safe and suitable for them to do. These will have been discussed with their heart specialist. The intervention group will then have 4 months to put the new lifestyle changes and exercise programme into practice. During this time the research doctor will keep in close contact to see how things are going and be available to answer any concerns. The control group will have their usual level of care. Both the intervention and control groups will be asked to return to the Department of Paediatric Cardiology at RBHSC at the end of the study for final assessment. This will be similar to the assessment performed at the start.

What are the possible benefits and risks of participating?
This study aims to promote a healthy lifestyle and increase the general activity levels of the participants. This will be done in a safe way, using an exercise programme designed for the participants’ condition and with advice from their heart specialist. We expect participants to experience benefits in terms of improved exercise tolerance, mood and self esteem.

Where is the study run from?
Department of Paediatric Cardiology, Royal Belfast Hospital For Sick Children (RBHSC), Belfast, Northern Ireland (UK).

When is the study starting and how long is it expected to run for?
It is hoped the study will commence in February 2014 and run for 2 years.

Who is funding the study?
Funding is to be confirmed.

Who is the main contact?
Dr Sinead Callaghan
scallaghan@doctors.org.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Frank Casey

ORCID ID

Contact details

Department of Paediatric Cardiology
Royal Belfast Hospital For Sick Children
180-184 Falls Road
Belfast
BT12 6BE
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Biophysical and psychosocial wellbeing in children with congenital heart disease: a structured programme of assessment and intervention

Acronym

Study hypothesis

There are two hypotheses forming the basis of the study. Firstly, is that physical and psychosocial health is reduced in children with major congenital heart disease compared to those with a minor diagnosis and secondly that a structured intervention programme could improve physical and psychosocial well-being.

Ethics approval

To be submittied to The Office for Research Ethics Committee of Northern Ireland (ORECNI) by October 2013

Study design

Single centre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Congenital Heart Disease

Intervention

1. Participants in the intervention group will attend a motivational style activity day to discuss attitudes to exercise. They will be given a structured exercise plan to practise at home over a four month period.
2. The control group received their usual level of care from the tertiary centre.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Increase in physical activity from that measured at baseline using exercise bike testing and during free-living activity using accelerometer technology.

Secondary outcome measures

Improvements in self-esteem, self-efficacy and general mental health functioning as a consequence of increased activity. These were assessed using standardised questionnaires.

Overall trial start date

01/02/2014

Overall trial end date

01/02/2016

Reason abandoned

Eligibility

Participant inclusion criteria

The potential participant group included all children aged 5-10 years with a primary diagnosis of congenital heart disease currently attending the Department of Paediatric Cardiology in Belfast for follow-up.

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

180

Participant exclusion criteria

1. Patients with a syndromic diagnosis (such as Down's)
2. Major learning difficulty or other serious co-morbidity that would render it difficult for them to follow the instructions required for participation were excluded from the project
3. Individuals with diagnoses for whom participation in exercise would be considered dangerous, e.g. hypertrophic obstructive cardiomyopathy

Recruitment start date

01/02/2014

Recruitment end date

01/02/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Paediatric Cardiology
Belfast
BT12 6BE
United Kingdom

Sponsor information

Organisation

Belfast Health and Social Care Trust (UK)

Sponsor details

Royal Victoria Hospital
274 Grosvenor Rd
Belfast
BT12 6BA
United Kingdom
frank.casey@belfasttrust.hscni.net

Sponsor type

Hospital/treatment centre

Website

http://www.belfasttrust.hscni.net/index.html

Funders

Funder type

Not defined

Funder name

To be confirmed

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes