Exercise Prehabilitation in Congenital Heart Disease

N/ANot Yet RecruitingNCT07700459

Liverpool Heart and Chest Hospital NHS Foundation Trust32 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Interventions

Exercise prehabilitationOTHER

Participants undertake a bespoke 6-week prehabilitation programme designed with an exercise physiologist, individualised to CPET results, baseline activity, and patient capability. It includes aerobic (progressive RPE-based, targeting 150-300 min/week moderate intensity with warm-up/cool-down), respiratory (inspiratory muscle training), and resistance training (major muscle groups, 15-30 repetitions, plus handgrip exercises). Equipment is provided. Participants also receive dietary and lifestyle advice with ongoing clinical support. Anxiety is addressed by the research team, with referral to psychology if required. Adherence is supported with at least fortnightly contact (phone/email/text). All participants undergo repeat CPET at 7-9 weeks. Participants are encouraged to continue exercises until surgery where feasible.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Outcomes

Primary Outcomes

Within-participant change in peak VO2 as measured on cardiopulmonary exercise test (CPET) at baseline and follow-up.

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.

Time frame: Baseline and follow-up CPETs (up to 9 weeks apart).

Secondary Outcomes

Individual change in forced vital capacity (litres) at baseline and follow-up.

Best of three acceptable attempts after usual inhaled medications (if taken) at baseline and follow-up. This is a routine measurement on a CPET at LHCH.

Time frame: Baseline and follow-up CPETs (up to 9 weeks apart)