Supported Exercise Programme for Adults With Congenital Heart Disease (SEACHange)

Golden Jubilee National Hospital

Status: Completed

Conditions: Congenital Disorder; Heart Diseases

Treatments: Other: Exercise Programme

Study type: Interventional

Funder types: Other

Identifiers

NCT03262168

GoldenJNH

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 28 patients

Sex: All

Ages: 16 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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28 participants in 4 patient groups

Study Group One

Other group

Description:

Six Minute Walk Test distance \<450metres. Exercise programme including inspiratory muscle trainer for 12 weeks. Contact weekly (via phone or email).

Treatment:

Other: Exercise Programme

Study Group Two

Other group

Description:

Six Minute Walk Test distance \>450metres. Exercise programme including walking for 12 weeks. Contact every second week (via phone or email).

Treatment:

Other: Exercise Programme

Study Group One - phase 2

Other group

Description:

Six Minute Walk Test distance \<450metres. Exercise programme including inspiratory muscle trainer for 12 weeks. Contact weekly (via phone or email).

Treatment:

Other: Exercise Programme

Study Group Two - phase 2

Other group

Description:

Six Minute Walk Test distance \>450metres. Exercise programme including walking for 12 weeks. Contact every second week (via phone or email).

Treatment:

Other: Exercise Programme