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Biophysical & psychosocial wellbeing in teenagers with congenital heart disease
ISRCTN ISRCTN27986270
DOI 10.1186/ISRCTN27986270
ClinicalTrials.gov identifier
EudraCT number
Public title Biophysical & psychosocial wellbeing in teenagers with congenital heart disease
Scientific title Biophysical & psychosocial wellbeing in teenagers with congenital heart disease: A structured programme of assessment and intervention
Acronym N/A
Serial number at source RGHT000534
Study hypothesis The hypothesis behind this study is twofold. Firstly that physical and psychosocial health is reduced in adolescents 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.
Lay summary Background and study aims
In Northern Ireland lots of new babies are born every year with heart problems and most of these children are growing up to reach adulthood. As they become teenagers many of them are taking responsibility for their condition for the first time and realising what it might mean for their future. Everyone knows that regular exercise and a healthy lifestyle can have good effects but few people get the recommended amount of activity each week. We believe that young people with heart problems are a group who could benefit from regular exercise. We would like to see how physical and mental health compares between young people with major and minor heart problems. We would like to see if by a supportive program we can encourage good life style choices and increase the amount of exercise this group gets. We would 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 better understanding of how young people and their families view their heart problems evidence that regular exercise can have good effects for young people with congenital heart disease.

Who can participate?
Patients with Congenital Heart Disease aged 12-20 years who attended the Department of Paediatric Cardiology at Royal Belfast Hospital For Sick Children (RBHSC) are invited to take part.

What does the study involve?
Participants will be randomly divided into 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 RBHSC for assessment. This will involve taking measurements such as height, weight and BMI (body mass index). Participants will be given a treadmill 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 will 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 6 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 the participantsí 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 at RBHSC, Belfast, Northern Ireland (UK).

When is the study starting and how long is it expected to run for?
The study took place between August 2008 and August 2010.

Who is funding the study?
The study is funded by a Royal Belfast Hospital for Sick Children Research Fellowship.

Who is the main contact?
Dr Margaret Louise Morrison
louisemorrison@doctors.org.uk
Ethics approval The Office for Research Ethics Committee of Northern Ireland (ORECNI), 27th June 2008, REC reference number 08/NIR02/44
Study design Single centre randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Congenital heart disease
Participants - inclusion criteria The potential participant group included all young people aged 12-20 years with a primary diagnosis of congenital heart disease currently attending the Department of Paediatric Cardiology in Belfast for follow-up.
Participants - 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
Anticipated start date 11/08/2008
Anticipated end date 11/08/2010
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 180
Interventions 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 six month period.

The control group received their usual level of care from the tertiary centre.
Primary outcome measure(s) Increase in physical activity from that measured at baseline using a standard treadmill protocol and during free-living activity using accelerometer technology.
Secondary outcome measure(s) Improvements in self-esteem, self-efficacy and general mental health functioning as a consequence of increased activity. These were assessed using standardised questionnaires.
Sources of funding Royal Belfast Hospital for Sick Children (RBHSC) (UK) - research fellowship
Trial website
Publications 2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23749780
Contact name Dr  Frank  Casey
  Address Department of Paediatric Cardiology
Royal Belfast Hospital for Sick Children
180 Falls Road
  City/town Belfast
  Zip/Postcode BT12 6BE
  Country United Kingdom
Sponsor Belfast Health and Social Care Trust (UK)
  Address Royal Victoria Hospital
274 Grosvenor Rd
  City/town Belfast
  Zip/Postcode BT12 6BA
  Country United Kingdom
  Sponsor website: http://www.belfasttrust.hscni.net/index.html
Date applied 27/01/2013
Last edited 12/09/2013
Date ISRCTN assigned 06/02/2013
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