Clinical trial NCT03262168: Supported Exercise Programme for Adults With Congenital Heart Disease
Official title: Supported Exercise Programme for Adults With Congenital Heart Disease (SEA CHange)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congenital Disorder
Heart Diseases
Keywords: Exercise
Physical Activity
Lead sponsor: Golden Jubilee National Hospital
Sponsor class: OTHER_GOV
First posted: 2017-08-25
Enrollment: 28
Sex: ALL
Minimum age (years): 16
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants compete a six minute walk test (6MWT). Those who achieve less than 450 metres will be assigned to study group one. Participants who achieve greater than 450 metres on 6MWT will be assigned to study group two.
Primary purpose: OTHER

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Attendance rate
timeFrame: 12 weeks (for each phase)
measure: Attrition rate
timeFrame: 12 weeks (for each phase)
Secondary outcomes:
measure: Change in six minute walk test (6MWT)
timeFrame: 12 weeks (for each phase)
measure: Change in Sniff Nasal Inspiratory Pressure (SNIP)
timeFrame: 12 weeks (for each phase)
measure: Change in Grip Strength
timeFrame: 12 weeks (for each phase)
measure: Is there an improvement in level of psychological distress
timeFrame: 12 weeks (for each phase)
measure: Is there an improvement in level of psychological distress
timeFrame: 12 weeks (for each phase)
measure: Body mass Index (BMI)
timeFrame: 12 weeks (for each phase)
measure: Body weight
timeFrame: 12 weeks (for each phase)
measure: Is there an improvement in bicep strength
timeFrame: 12 weeks (for each phase)
measure: Is there an improvement in quadricep strength
timeFrame: 12 weeks (for each phase)
Other outcomes:
Locations:
city: Clydebank
country: United Kingdom
facility: Golden Jubilee National Hospital
Study officials:
affiliation: Golden Jubilee Research Institute
name: Maureen Mason, MSc
role: STUDY_CHAIR
References: