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NCT Number: NCT07700459

Exercise Prehabilitation in Congenital Heart Disease

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.

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Key information

Conditions

Congenital Heart Disease Cardiac Surgery Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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).

    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.

Secondary outcomes

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

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Elen H Hughes, MBBCh

CONTACT

[email protected]

+44 01516001616

Julia D Jones, MD

CONTACT

[email protected]

+44 01516001616

Sponsors and collaborators

Lead sponsor

Liverpool Heart and Chest Hospital NHS Foundation Trust

Other

Collaborators

  • Liverpool John Moores University

Registry information

Official study title

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.

Acronym: ACE-CHD

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Jul 14, 2026
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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