Exercise Prehabilitation in Congenital Heart Disease

Sponsor
Liverpool Heart and Chest Hospital NHS Foundation Trust
Study ID
NCT07700459
Status
Not Yet Recruiting

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Conditions

  • Cardiac Surgery
  • Congenital Heart Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Exercise prehabilitation — OTHER
    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.

Study Details

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.

Key Dates

First listed
Jul 14, 2026
Start date
Aug 10, 2026
Status verified
Jul 2026
Primary completion
Jun 1, 2029
Completion
Jun 1, 2029

Study Design

Enrollment
32 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: 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.
  • No Intervention: 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.

Primary Outcome Measure

Within-participant change in peak VO2 as measured on cardiopulmonary exercise test (CPET) at baseline and follow-up. [ Time Frame: Baseline and follow-up CPETs (up to 9 weeks apart). ]

Central Contacts

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