Skip to main content
OpenTrials
Completed

NCT Number: NCT03262168

Supported Exercise Programme for Adults With Congenital Heart Disease

This study will evaluate if the introduction of a supported exercise programme can improve physical and psychological well-being for adults with congenital heart disease.

Completed

Looking for future studies?

Notify Me

Key information

Age range

16 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Golden Jubilee National Hospital

Clydebank, G81 4DY, United Kingdom

About this study

Congenital heart disease (CHD) describes heart defects present from birth. The majority of affected patients will require lifelong care to not only manage their medical condition, but also to offer support and guidance on living with their specific heart condition. Exercise and physical activity is one such area where patients often require support and advice. Recommendations are in place for health care providers to promote physical activity for this patient population. However, many health care providers find it difficult to know what level of exercise is reasonable or how to escalate current exercise programmes.

The benefits of regular exercise are well known and evidence suggests that even a modest increase in physical activity can reduce morbidity, improve psychological wellbeing and protect against cardiovascular disease.

This pilot study will determine the feasibility of introducing a supported exercise programme to clinical practice. The investigators aim to assess if improvements can be made in both physical and psychological well-being for adults with CHD who are living in Scotland. After initial assessment and baseline measurements are obtained, participants will follow a twelve week individualised programme. The investigators will keep in regular contact with the participant throughout and arrange interval and final assessments. The baseline measurements will be repeated during the final assessment at 12 weeks. Investigators anticipate that the study will also help to establish a programme that will help to improve the way adults who were born with a heart condition can be supported with physical activity on a long term basis.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Living in Scotland
  • Diagnosis of congenital heart disease
  • Walks less than 450 metres on a 6 minute walk test (Group 1)
  • Walks more than 450 metres on a 6 minute walk test (Group 2)

Exclusion criteria

  • No access to internet or telephone
  • Non English speaking (If the pilot study is successful, we anticipate that materials and programmes could be translated and accessible to non English speakers)
  • Vulnerable adults
  • Severe aortic stenosis or severe left ventricular outflow tract obstruction (LVOTO)
  • Eisenmenger Physiology (ongoing study recruitment with SPVU)
  • Currently prescribed Advanced Pulmonary Vasodilator therapy

Treatment and study plan

Exercise programme

Other

Complete background demographics, Sniff Nasal Inspiratory Pressure (study group one only), grip strength, muscle strength, PHQ-9 and GAD-7 questionnaires.

Primary outcomes

  1. Attendance rate

    Time frame: 12 weeks (for each phase)

    Determine the feasibility of introducing a supported exercise programme in to clinical practice. This will be measured through attendance to the programme and interaction with the online resource.

  2. Attrition rate

    Time frame: 12 weeks (for each phase)

    Determine the feasibility of introducing a supported exercise programme by assessing attrition rate throughout the study period.

Secondary outcomes

  1. Change in six minute walk test (6MWT)

    Time frame: 12 weeks (for each phase)

    Change in six minute walk test distance (metres) between 0 and 12 weeks. Offers a simple, readily available and cost effective method for objective evaluation of functional exercise capacity during daily activity.

  2. Change in Sniff Nasal Inspiratory Pressure (SNIP)

    Time frame: 12 weeks (for each phase)

    Change in Sniff Nasal Inspiratory Pressure (SNIP) between 0 and 12 weeks (study group one). Measured in cmH2O and is used to measure inspiratory muscle strength.

  3. Change in Grip Strength

    Time frame: 12 weeks (for each phase)

    Change in grip strength. This is measured in pounds (lbs) using a myometer. It is a recognized method of assessing overall nutritional status and health in subjects with medical conditions.

  4. Is there an improvement in level of psychological distress

    Time frame: 12 weeks (for each phase)

    Change in level of depression (measured using PHQ- 9 questionnaire). It is a reliable and validated self report questionnaire used to help clinicians screen for depression disorder.

  5. Is there an improvement in level of psychological distress

    Time frame: 12 weeks (for each phase)

    Change in level of anxiety (measured using GAD-7 questionnaire). The GAD -7 is a self report questionnaire used to identify probable cases of generalised anxiety disorder. Recognised as a valid and reliable screening tool

  6. Body mass Index (BMI)

    Time frame: 12 weeks (for each phase)

    Change in body mass index (measured in kg/m2). Weight (kgs) and height (metres) will be combined to report BMI in kg/m2

  7. Body weight

    Time frame: 12 weeks (for each phase)

    Change in body weight (measured in kg)

  8. Is there an improvement in bicep strength

    Time frame: 12 weeks (for each phase)

    Change in bicep strength. This is measured in newtons (N) using a non invasive strain guage/myometer

  9. Is there an improvement in quadricep strength

    Time frame: 12 weeks (for each phase)

    Change in quadricep strength. This is measured in newtons (N) using a non invasive strain guage/myometer

Sponsors and collaborators

Lead sponsor

Golden Jubilee National Hospital

Other Gov

Registry information

Official study title

Supported Exercise Programme for Adults With Congenital Heart Disease (SEA CHange)

Acronym: SEACHange

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 25, 2017
Registry last updated
Jul 31, 2019

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.

Published trials that share one or more normalized conditions with this study.