Exercise Prehabilitation in Congenital Heart Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLiverpool Heart and Chest Hospital NHS Foundation Trust
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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%.
Trial design
Design model
Parallel
Treatments tested in this trial
Exercise prehabilitation
Other interventionParticipants 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.
Treatment groups
32 Participants
are divided into 2 treatment groupsGroup A: Prehabilitation ArmExperimental treatment 1 intervention
Group B: Control ArmNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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
1
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)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Liverpool Heart and Chest Hospital NHS Foundation Trust
Lead sponsor
Liverpool John Moores University
Collaborator
Source ClinicalTrials.gov