Supported Exercise Programme for Adults With Congenital Heart Disease (SEA CHange)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Attendance rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
Study Group One
Six Minute Walk Test distance <450metres. Exercise programme including inspiratory muscle trainer for 12 weeks. Contact weekly (via phone or email).
干预措施: Exercise Programme (Other)
Study Group Two
Six Minute Walk Test distance >450metres. Exercise programme including walking for 12 weeks. Contact every second week (via phone or email).
干预措施: Exercise Programme (Other)
Study Group One - phase 2
Six Minute Walk Test distance <450metres. Exercise programme including inspiratory muscle trainer for 12 weeks. Contact weekly (via phone or email).
干预措施: Exercise Programme (Other)
Study Group Two - phase 2
Six Minute Walk Test distance >450metres. Exercise programme including walking for 12 weeks. Contact every second week (via phone or email).
干预措施: Exercise Programme (Other)
结局指标
主要结局
Attendance rate
时间窗: 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.
Attrition rate
时间窗: 12 weeks (for each phase)
Determine the feasibility of introducing a supported exercise programme by assessing attrition rate throughout the study period.
次要结局
- Change in six minute walk test (6MWT)(12 weeks (for each phase))
- Change in Sniff Nasal Inspiratory Pressure (SNIP)(12 weeks (for each phase))
- Change in Grip Strength(12 weeks (for each phase))
- Body weight(12 weeks (for each phase))
- Body mass Index (BMI)(12 weeks (for each phase))
- Is there an improvement in bicep strength(12 weeks (for each phase))
- Is there an improvement in quadricep strength(12 weeks (for each phase))
- Is there an improvement in level of psychological distress(12 weeks (for each phase))