An interventional study of Exercise Programme in Congenital Disorder and Heart Diseases, sponsored by Golden Jubilee National Hospital. Completed at 1 site in United Kingdom. Open to participants aged 16 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-07-31.
Sponsored by Golden Jubilee National Hospital · Not applicable, Interventional, and Other
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.
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.
109 studies on the registry are indexed under Congenital, Hereditary, and Neonatal Diseases and Abnormalities; 19 are open to participants now.
This study's enrollment of 28 is below the median of 40 across 29 interventional studies indexed under Congenital, Hereditary, and Neonatal Diseases and Abnormalities.
Browse Congenital, Hereditary, and Neonatal Diseases and Abnormalities studies →Golden Jubilee National Hospital is the lead sponsor of 30 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
Six Minute Walk Test distance \<450metres. Exercise programme including inspiratory muscle trainer for 12 weeks. Contact weekly (via phone or email).
Other: Exercise Programme
Six Minute Walk Test distance \>450metres. Exercise programme including walking for 12 weeks. Contact every second week (via phone or email).
Other: Exercise Programme
Six Minute Walk Test distance \<450metres. Exercise programme including inspiratory muscle trainer for 12 weeks. Contact weekly (via phone or email).
Other: Exercise Programme
Six Minute Walk Test distance \>450metres. Exercise programme including walking for 12 weeks. Contact every second week (via phone or email).
Other: Exercise Programme
Complete background demographics, Sniff Nasal Inspiratory Pressure (study group one only), grip strength, muscle strength, PHQ-9 and GAD-7 questionnaires.
Attendance rate
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.
Time frame: 12 weeks (for each phase)
Attrition rate
Determine the feasibility of introducing a supported exercise programme by assessing attrition rate throughout the study period.
Time frame: 12 weeks (for each phase)
Change in six minute walk test (6MWT)
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.
Time frame: 12 weeks (for each phase)
Change in Sniff Nasal Inspiratory Pressure (SNIP)
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.
Time frame: 12 weeks (for each phase)
Change in Grip Strength
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.
Time frame: 12 weeks (for each phase)
Is there an improvement in level of psychological distress
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.
Time frame: 12 weeks (for each phase)
Is there an improvement in level of psychological distress
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
Time frame: 12 weeks (for each phase)
Body mass Index (BMI)
Change in body mass index (measured in kg/m2). Weight (kgs) and height (metres) will be combined to report BMI in kg/m2
Time frame: 12 weeks (for each phase)
Body weight
Change in body weight (measured in kg)
Time frame: 12 weeks (for each phase)
Is there an improvement in bicep strength
Change in bicep strength. This is measured in newtons (N) using a non invasive strain guage/myometer
Time frame: 12 weeks (for each phase)
Is there an improvement in quadricep strength
Change in quadricep strength. This is measured in newtons (N) using a non invasive strain guage/myometer
Time frame: 12 weeks (for each phase)
Plan to share: No — No plan to share individual data
No publications or documents are linked to this record.
Ran from Jun 2017 to primary completion in Dec 2018, 18 months.
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This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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Congenital, Hereditary, and Neonatal Diseases and Abnormalities →
Golden Jubilee National Hospital