Exercise Prehabilitation in Congenital Heart Disease

Официальное название

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.

Обзор

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.

Вмешательства

• Другое Exercise prehabilitation
  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

Первичные конечные точки

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

Вторичные конечные точки (1)

• Individual change in forced vital capacity (litres) at baseline and follow-up. [Срок оценки: Baseline and follow-up CPETs (up to 9 weeks apart)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• NHS Liverpool Clinical Commissioning Group. One Liverpool Strategy 2019-2024. In: NHS England, ed. Online; 2019.
• Department of Health and Social Care. Fit for the future: 10 Year Health Plan for England. In: Care DoHaS, ed. Online; 2025.
• NHS England. NHS Long Term Plan. In: England N, ed; 2019.
• 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. PMID 16367493
• 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 dis PMID 32860412
• 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. PMID 37869879
• 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. PMID 39063586
• 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. PMID 39843215

Идентификаторы

NCT: NCT07700459 · 1696

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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