Exercise-based Cardiac Rehabilitation for Patients with Atrial Fibrillation Receiving Catheter Ablation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Patient focus groups to assess intervention and testing acceptability
研究概览
简要总结
The investigators aim to conduct a pilot randomised controlled trial (RCT) with embedded feasibility study to evaluate an exercise-based cardiac rehabilitation (ExCR) programme when delivered to patients with atrial fibrillation on the waiting list for catheter ablation. Our overall objective is to test the feasibility and acceptability of an evidence-based ExCR intervention prior to evaluation in a future randomized controlled trial (RCT).
详细描述
A two-arm pilot randomised feasibility trial (RCT) with embedded process evaluation will be undertaken as a phased programme of work. Patients on a waiting list for catheter ablation will be offered a referral to cardiac rehabilitation. The intervention consists of supervised exercise sessions run by a clinical exercise physiologist and psychoeducation sessions. The trial will involve one National Health Service (NHS) research site, Liverpool Heart and Chest NHS Foundation Trust enrolling patients (n=60) to assess intervention and study design processes. Primary outcomes are recruitment rate, adherence to the ExCR and loss to follow-up. Semi-structured interviews and focus groups with patients and clinicians will be used to gather data on the acceptability of the intervention and study procedures. Secondary outcome measures will be taken at baseline (preintervention), postintervention and at 6 month follow-up for both phases and will consist of exercise capacity measured by AF burden, AF recurrence, quality of life, exercise capacity, and cardiac structure and function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant is willing and able to give informed consent for participation in the study.
- •Aged ≥18 years.
- •Diagnosed with AF and on a waiting list or referred for medical treatment for symptomatic AF (eg catheter ablation).
- •Is eligible and willing to take part in an ExCR programme.
排除标准
- •Blood pressure >180/
- •Unstable angina.
- •Severe valvular heart disease as diagnosed by echocardiography.
- •Heart failure New York Heart Association (NYHA) class
- •<6 months post-transplant.
- •Resting/uncontrolled tachycardia.
- •Stroke in last 6 weeks.
- •Cardiac sarcoidosis.
- •Injury or disability preventing exercise.
- •Inability to understand trial procedures e.g. difficulties with speaking and understanding the English language.
结局指标
主要结局
Patient focus groups to assess intervention and testing acceptability
时间窗: Up to 20 weeks from baseline
Patient Focus Groups
Clinical exercise physiologist interview to assess intervention and testing acceptability
时间窗: Up to 20 weeks from baseline
Clinical Exercise Physiologist Interview
Number of patients screened, eligible and approached
时间窗: Baseline
The percentage of patients that are screened, eligible and approached decline CR (including reasons for declining) agree to CR and consent to being part of the study The percentage of patients that take up standard CR and reasons for drop out; and the percentage of participants that complete outcome assessments and reasons for drop out.
次要结局
- Changes in AF burden(At baseline, post intervention (8-10 weeks) and 6 months after intervention)
- AF Recurrence(At baseline, post intervention (8-10 weeks) and 6 months after intervention)
- Disease specific quality of life measured by the AFEQT questionnaire(At baseline, post intervention (8-10 weeks) and 6 months after intervention)
- General quality of life as measured by the EQ-5D-5L questionnaire(At baseline, post intervention (8-10 weeks) and 6 months after intervention)
- VO2 peak measured via CPET(At baseline, post intervention (8-10 weeks) and 6 months after intervention)
- Exercise capacity measured via the 6MWT(At baseline, post intervention (8-10 weeks) and 6 months after intervention)
- Cardiac structure and function measured via echocardiography(At baseline, post intervention (8-10 weeks) and 6 months after intervention)