Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Liverpool John Moores University | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
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. We now know 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.
We 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.
Our 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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prehabilitation Arm | Experimental | 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. |
|
| Control Arm | No Intervention | Standard preoperative management, which includes routine surgical clinic assessments, medical clinic appointments, preoperative nursing reviews and access to the ACHD nurse helpline as normal. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and follow-up CPETs (up to 9 weeks apart). |
| Measure | Description | Time Frame |
|---|---|---|
| Individaul 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. | Baseline and follow-up CPETs (up to 9 weeks apart) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
The oldest person operated upon by the ACHD service was 78 years old. Upper age is not an exclusion criteria.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elen H Hughes, MBBCh | Contact | +44 01516001616 | elen.hughes@lhch.nhs.uk | |
| Julia D Jones, MD | Contact | +44 01516001616 | julia.jones3@lhch.nhs.uk |
| Name | Affiliation | Role |
|---|---|---|
| Julia D Jones, MD | Liverpool Heart and Chest Hospital NHS Foundation Trust | Principal Investigator |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | NHS Liverpool Clinical Commissioning Group. One Liverpool Strategy 2019-2024. In: NHS England, ed. Online; 2019. | ||
| Background | Department of Health and Social Care. Fit for the future: 10 Year Health Plan for England. In: Care DoHaS, ed. Online; 2025. | ||
| Background | NHS England. NHS Long Term Plan. In: England N, ed; 2019. | ||
| 16367493 | Background | Diener E, Emmons RA, Larsen RJ, Griffin S. The Satisfaction With Life Scale. J Pers Assess. 1985 Feb;49(1):71-5. doi: 10.1207/s15327752jpa4901_13. | |
Not provided
Not provided
Pooled data will be published.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
Not provided
Not provided
This single-centre, prospective, outcome-blinded, feasibility, randomised controlled trial with a qualitative substudy, assessing prehabilitation in ACHD patients, excluding patients with high initial fitness levels, and hence less chance of clinical benefit from exercise prehabilitation impact, referred for elective cardiac surgery, will be conducted at Liverpool Heart and Chest Hospital (LHCH).
Not provided
Not provided
The study will be outcome-blinded. Only the study team will have access to randomised allocation.
|
| Background |
| Pelliccia A, Sharma S, Gati S, Back M, Borjesson M, Caselli S, Collet JP, Corrado D, Drezner JA, Halle M, Hansen D, Heidbuchel H, Myers J, Niebauer J, Papadakis M, Piepoli MF, Prescott E, Roos-Hesselink JW, Graham Stuart A, Taylor RS, Thompson PD, Tiberi M, Vanhees L, Wilhelm M; ESC Scientific Document Group. 2020 ESC Guidelines on sports cardiology and exercise in patients with cardiovascular disease. Eur Heart J. 2021 Jan 1;42(1):17-96. doi: 10.1093/eurheartj/ehaa605. No abstract available. |
| 37869879 | Background | Ferrero P, Piazza I, Poggioli G, Chessa M, Lorenzelli F. Long-term effects of physical training on cardiopulmonary exercise parameters in young patients with congenital heart diseases. Cardiol Young. 2024 Apr;34(4):831-837. doi: 10.1017/S1047951123003621. Epub 2023 Oct 23. |
| 39063586 | Background | Bargnes V 3rd, Davidson S, Talbot L, Jin Z, Poppers J, Bergese SD. Start Strong, Finish Strong: A Review of Prehabilitation in Cardiac Surgery. Life (Basel). 2024 Jun 29;14(7):832. doi: 10.3390/life14070832. |
| 39843215 | Background | McIsaac DI, Kidd G, Gillis C, Branje K, Al-Bayati M, Baxi A, Grudzinski AL, Boland L, Veroniki AA, Wolfe D, Hutton B. Relative efficacy of prehabilitation interventions and their components: systematic review with network and component network meta-analyses of randomised controlled trials. BMJ. 2025 Jan 22;388:e081164. doi: 10.1136/bmj-2024-081164. |
| 33030962 | Background | Assouline B, Cools E, Schorer R, Kayser B, Elia N, Licker M. Preoperative Exercise Training to Prevent Postoperative Pulmonary Complications in Adults Undergoing Major Surgery. A Systematic Review and Meta-analysis with Trial Sequential Analysis. Ann Am Thorac Soc. 2021 Apr;18(4):678-688. doi: 10.1513/AnnalsATS.202002-183OC. |
| 29679727 | Background | Shen F, Kim HJ, Lee NK, Chun HJ, Chang BS, Lee CK, Yeom JS. The influence of hand grip strength on surgical outcomes after surgery for degenerative lumbar spinal stenosis: a preliminary result. Spine J. 2018 Nov;18(11):2018-2024. doi: 10.1016/j.spinee.2018.04.009. Epub 2018 Apr 18. |
| 4068194 | Background | Hunt DR, Rowlands BJ, Johnston D. Hand grip strength--a simple prognostic indicator in surgical patients. JPEN J Parenter Enteral Nutr. 1985 Nov-Dec;9(6):701-4. doi: 10.1177/0148607185009006701. |
| 32944327 | Background | Park HJ, Kim SM, Kim HR, Ji W, Choi CM. The value of preoperative spirometry testing for predicting postoperative risk in upper abdominal and thoracic surgery assessed using big-data analysis. J Thorac Dis. 2020 Aug;12(8):4157-4167. doi: 10.21037/jtd-19-2687. |
| 38992072 | Background | Amirkhosravi F, Allenson KC, Moore LW, Kolman JM, Foster M, Hsu E, Sasangohar F, Dhala A. Multimodal prehabilitation and postoperative outcomes in upper abdominal surgery: systematic review and meta-analysis. Sci Rep. 2024 Jul 11;14(1):16012. doi: 10.1038/s41598-024-66633-6. |
| 36529576 | Background | Roxburgh BH, Cotter JD, Campbell HA, Reymann U, Wilson LC, Gwynne-Jones D, van Rij AM, Thomas KN. Physiological relationship between cardiorespiratory fitness and fitness for surgery: a narrative review. Br J Anaesth. 2023 Feb;130(2):122-132. doi: 10.1016/j.bja.2022.10.039. Epub 2022 Dec 16. |
| 35579479 | Background | Rose GA, Davies RG, Appadurai IR, Williams IM, Bashir M, Berg RMG, Poole DC, Bailey DM. 'Fit for surgery': the relationship between cardiorespiratory fitness and postoperative outcomes. Exp Physiol. 2022 Aug;107(8):787-799. doi: 10.1113/EP090156. Epub 2022 Jun 5. |
| 34101066 | Background | Steffens D, Ismail H, Denehy L, Beckenkamp PR, Solomon M, Koh C, Bartyn J, Pillinger N. Preoperative Cardiopulmonary Exercise Test Associated with Postoperative Outcomes in Patients Undergoing Cancer Surgery: A Systematic Review and Meta-Analyses. Ann Surg Oncol. 2021 Nov;28(12):7120-7146. doi: 10.1245/s10434-021-10251-3. Epub 2021 Jun 8. |
| 24990282 | Background | Sterrett LE, Ebenroth ES, Query C, Ho J, Montgomery GS, Hurwitz RA, Baye F, Schamberger MS. Why exercise capacity does not improve after pulmonary valve replacement. Pediatr Cardiol. 2014 Dec;35(8):1395-402. doi: 10.1007/s00246-014-0942-2. Epub 2014 Jul 3. |
| 27252876 | Background | Le VD, Jensen GV, Kjoller-Hansen L. Observed change in peak oxygen consumption after aortic valve replacement and its predictors. Open Heart. 2016 May 26;3(1):e000309. doi: 10.1136/openhrt-2015-000309. eCollection 2016. |
| 35389228 | Background | Lopez KN, Baker-Smith C, Flores G, Gurvitz M, Karamlou T, Nunez Gallegos F, Pasquali S, Patel A, Peterson JK, Salemi JL, Yancy C, Peyvandi S; American Heart Association Congenital Cardiac Defects Committee of the Council on Lifelong Congenital Heart Disease and Heart Health in the Young; Council on Epidemiology and Prevention; and Council on Lifestyle and Cardiometabolic Health. Addressing Social Determinants of Health and Mitigating Health Disparities Across the Lifespan in Congenital Heart Disease: A Scientific Statement From the American Heart Association. J Am Heart Assoc. 2022 Apr 19;11(8):e025358. doi: 10.1161/JAHA.122.025358. Epub 2022 Apr 7. |
| 33968634 | Background | Niwa K. Metabolic syndrome and coronary artery disease in adults with congenital heart disease. Cardiovasc Diagn Ther. 2021 Apr;11(2):563-576. doi: 10.21037/cdt-20-781. |
| 22221213 | Background | Popkin BM, Adair LS, Ng SW. Global nutrition transition and the pandemic of obesity in developing countries. Nutr Rev. 2012 Jan;70(1):3-21. doi: 10.1111/j.1753-4887.2011.00456.x. |
| 11117387 | Background | Bar-Mor G, Bar-Tal Y, Krulik T, Zeevi B. Self-efficacy and physical activity in adolescents with trivial, mild, or moderate congenital cardiac malformations. Cardiol Young. 2000 Nov;10(6):561-6. doi: 10.1017/s1047951100008829. |
| 10467807 | Background | Bar-Mor G, Zeevi B, Yaaron M, Falk B. Use of the heart rate monitor to modulate physical activity in adolescents with congenital aortic stenosis: an innovative approach. J Pediatr Nurs. 1999 Aug;14(4):273-7. doi: 10.1016/S0882-5963(99)80026-8. |
| 16061735 | Background | Diller GP, Dimopoulos K, Okonko D, Li W, Babu-Narayan SV, Broberg CS, Johansson B, Bouzas B, Mullen MJ, Poole-Wilson PA, Francis DP, Gatzoulis MA. Exercise intolerance in adult congenital heart disease: comparative severity, correlates, and prognostic implication. Circulation. 2005 Aug 9;112(6):828-35. doi: 10.1161/CIRCULATIONAHA.104.529800. Epub 2005 Aug 1. |
| 36097575 | Background | Silvapulle E, Darvall J. Objective methods for preoperative assessment of functional capacity. BJA Educ. 2022 Aug;22(8):312-320. doi: 10.1016/j.bjae.2022.03.003. Epub 2022 May 25. No abstract available. |
| 34266577 | Background | Constantine A, Costola G, Bianchi P, Chessa M, Giamberti A, Kempny A, Rafiq I, Babu-Narayan SV, Gatzoulis MA, Hoschtitzky A, Shore D, Aw TC, Ranucci M, Dimopoulos K. Enhanced Assessment of Perioperative Mortality Risk in Adults With Congenital Heart Disease. J Am Coll Cardiol. 2021 Jul 20;78(3):234-242. doi: 10.1016/j.jacc.2021.04.096. |
| 32860028 | Background | Baumgartner H, De Backer J, Babu-Narayan SV, Budts W, Chessa M, Diller GP, Lung B, Kluin J, Lang IM, Meijboom F, Moons P, Mulder BJM, Oechslin E, Roos-Hesselink JW, Schwerzmann M, Sondergaard L, Zeppenfeld K; ESC Scientific Document Group. 2020 ESC Guidelines for the management of adult congenital heart disease. Eur Heart J. 2021 Feb 11;42(6):563-645. doi: 10.1093/eurheartj/ehaa554. No abstract available. |
| 29338307 | Background | Marmelo F, Rocha V, Moreira-Goncalves D. The impact of prehabilitation on post-surgical complications in patients undergoing non-urgent cardiovascular surgical intervention: Systematic review and meta-analysis. Eur J Prev Cardiol. 2018 Mar;25(4):404-417. doi: 10.1177/2047487317752373. Epub 2018 Jan 17. |
| 30765210 | Background | McCann M, Stamp N, Ngui A, Litton E. Cardiac Prehabilitation. J Cardiothorac Vasc Anesth. 2019 Aug;33(8):2255-2265. doi: 10.1053/j.jvca.2019.01.023. Epub 2019 Jan 12. |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |