A Randomised-controlled Trial to Assess the Impact of Prehabilitation and a Structured Exercise Programme on Cardiorespiratory Performance in Adults Awaiting Elective Surgery for Congenital Heart Disease: The ACE-CHD Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 32
- 主要终点
- Within-participant change in peak VO2 as measured on cardiopulmonary exercise test (CPET) at baseline and follow-up.
研究概览
简要总结
Around 8-12 in every 1000 babies are born with an abnormal heart, known as a congenital heart defect (CHD).
Thanks to major advances in medical and surgical care, most babies born with CHD now live into adulthood.
As people with CHD get older, many need repeated heart operations. It is known from other areas of medicine that "prehabilitation" - a short, structured exercise programme completed before surgery - can improve fitness and help patients cope better with major operations. However, this approach has never been tested in adults with CHD. The investigators are running a randomised controlled trial to find out whether a prehabilitation programme can improve physical fitness before heart surgery in adults with CHD.
Participants will be randomly assigned to usual care or a prehabilitation group. Those in the prehabilitation group will follow a tailored, supervised exercise plan for several weeks before surgery.
All patients undergoing cardiac surgery routinely complete a cardiopulmonary exercise test (CPET) as part of their standard pre-operative assessment. CPET is a well-established test that shows how the heart and lungs respond to increasing levels of exercise. During the test, participants exercise on a bike while their breathing, heart rate, and overall physiological response are continuously monitored.
The results of each participant's routine CPET will be used to guide the individualised exercise programme in the intervention group.
Exercise levels prescribed in the study will not exceed the intensity already safely achieved during the routine CPET, ensuring that activity remains within clinically assessed limits.
Participants in the trial will complete an additional second CPET following the trial period.
The key question is whether a tailored exercise programme can improve fitness in adults with CHD before heart surgery, and whether this approach is feasible, acceptable and practical to deliver, including successful recruitment and measurable physiological improvements.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
The study will be outcome-blinded. Only the study team will have access to randomised allocation.
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
- •Adults with congenital heart disease requiring cardiac surgery via sternotomy or thoracotomy.
- •Capacity to provide informed consent.
- •Ability and willingness to engage in exercise-based interventions.
- •Peak VO2 <30ml/kg/min at preoperative exercise assessment.
- •Participant reached peak VO2 in preoperative exercise assessment (RER >1.0).
- •Ability to communicate in English.
排除标准
- •Surgery is scheduled for a date that precludes participation in the programme - surgical date is <9 weeks away.
- •Pregnancy of <6 months postpartum.
- •History of pneumothorax within the last 3 months.
- •Resting oxygen saturations <94%.
- •Uncorrected right-to-left shunt with exercise.
- •Fontan physiology.
- •Pulmonary hypertension.
- •Critical valvular obstruction.
- •Sustained ventricular arrhythmia.
- •Severe aortic dilatation (>45mm in Marfan syndrome or hereditary aortopathy, >50mm in bicuspid or tricuspid aortic valves).
- •The oldest person operated upon by the ACHD service was 78 years old. Upper age is not an exclusion criteria.
研究组 & 干预措施
Prehabilitation Arm
Participants will undertake a bespoke 6-week prehabilitation programme designed with an exercise physiologist. The programme is individualised based on CPET results, baseline activity, and patient capability. It includes cardiovascular, respiratory, and resistance training. Aerobic exercise is prescribed using a progressive Rating of Perceived Exertion (RPE) approach, targeting 150-300 minutes/week of moderate-intensity activity in line with ESC guidance, with warm-up and cool-down. Respiratory training is delivered using an inspiratory muscle trainer. Resistance training targets major muscle groups (15-30 repetitions) using bands, with additional handgrip exercises. Equipment is provided. Participants also receive dietary and lifestyle advice with ongoing clinical support.
干预措施: Exercise prehabilitation (Other)
Control Arm
Standard preoperative management, which includes routine surgical clinic assessments, medical clinic appointments, preoperative nursing reviews and access to the ACHD nurse helpline as normal.
结局指标
主要结局
Within-participant change in peak VO2 as measured on cardiopulmonary exercise test (CPET) at baseline and follow-up.
时间窗: Baseline and follow-up CPETs (up to 9 weeks apart).
The primary outcome will be the within-participant change in peak VO2 as measured on cardiopulmonary exercise test (CPET) at baseline and at follow-up.
次要结局
- Individaul change in forced vital capacity (litres) at baseline and follow-up.(Baseline and follow-up CPETs (up to 9 weeks apart))
- Individual change in forced vital capacity (litres) at baseline and follow-up.(Baseline and follow-up CPETs (up to 9 weeks apart))