Prehabilitation for Patients Undergoing Lung Cancer Surgery

Официальное название

Digitally Enabled Prehabilitation in a Community-based Setting for Patients Undergoing Lung Cancer Surgery

Обзор

Major surgery has been linked to running a marathon as in both represent large endeavours where the body will experience an increase in demands to supply the necessary energy. It has been alledged that, as one would train to prepare for a marathon, the same should be applied to surgery. The process of getting ready and/or fitter for surgery is frequently referred to as prehabilitation and it usually involves interventions on improving nutrition and diet, getting fit and improve emotional wellness. Prehabilitation can improve the recovery after surgery and reduce the time spent in hospital afterwards. This research seeks to determine whether a home based program of increased physical activity and breathing training can improve patients' physical and respiratory function in preparation for lung cancer surgery.

Подробное описание

Patients with lung cancer who are scheduled to undergo lung resection surgery will be provided with a digitally-enabled, remotely-monitored prehablitation program. The intervention will consist of the following components: i) general education; ii) inspiratory muscle training; iii) physical activity coaching; and iv) home-based exercise training. The program will be supported with a mobile app and weekly telehealth sessions with one experienced physiotherapist. Participants will be assessed at baseline and at the end of the intervention, prior to surgery. Participants will be contacted and scheduled to undergo face-to-face assessments on lung function, respiratory muscle strength, and functional capacity both at baseline and after the prehabilitation program.

Вмешательства

• Поведенческое Prehabilitation
  Patients will undergo a physiotherapy-led digitally-enabled prehabilitation program before lung resection surgery. The intervention will be delivered through a mobile app and supported by tele-health and will consist of: i) watching six educational videos embedded on the app on relevant topics to prepare for surgery, such as the importance of physical fitness, breathing exercises after surgery, and pain management. ii) a physical activity coaching program to increase daily activity with feedb

Первичные конечные точки

• Feasibility of the intervention [Срок оценки: From enrollment to the end of the study approximately one week after surgery]
• App usability and acceptability [Срок оценки: Within one week before surgery]

Вторичные конечные точки (8)

• Safety of the intervention [Срок оценки: From enrollment to the end of the program before surgery]
• Inspiratory Muscle Strength [Срок оценки: Within one week before surgery]
• Diaphragmatic excursion and thickness [Срок оценки: Within one week before surgery]
• Lung function [Срок оценки: Within one week before surgery]
• Self-efficacy [Срок оценки: Within one week before surgery]
• Participant satisfaction [Срок оценки: Within one week before surgery]
• Health Related Quality of Life [Срок оценки: Within one week before surgery]
• Recovery from surgery [Срок оценки: Within one week before surgery]

Критерии участия

Критерии включения

• Diagnosis of lung cancer and scheduled for lung resection surgery
• Ability to understand and speak English to follow instructions and complete the intended assessments.
• Age ≥ 18 years at the point of baseline screening
• Provide written informed consent for the trial
• Sufficient digital literacy to use a smartphone and mobile app
• No contraindications for exercise

Критерии исключения

• Other cancer diagnoses than lung cancer
• Surgery scheduled in less than one week
• Unstable psychiatric, cognitive or substance abuse disorders that would interfere with cooperation with the requirements of the trial

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Австралия · 1 центр

• The University of Melbourne, Department of Physiotherapy — Parkville

Публикации

• Waterland JL, Ismail H, Amin B, Granger CL, Denehy L, Riedel B. Patient acceptance of prehabilitation for major surgery: an exploratory survey. Support Care Cancer. 2021 Feb;29(2):779-785. doi: 10.1007/s00520-020-05547-1. Epub 2020 May 28. PMID 32462351
• Whish-Wilson GA, Edbrooke L, Cavalheri V, Denehy L, Seller D, Granger CL, Parry SM. Physiotherapy and Exercise Management of People Undergoing Surgery for Lung Cancer: A Survey of Current Practice across Australia and New Zealand. J Clin Med. 2023 Mar 9;12(6):2146. doi: 10.3390/jcm12062146. PMID 36983146
• Kunadharaju R, Saradna A, Ray A, Yu H, Ji W, Zafron M, Mador MJ. Post-Operative Outcomes of Pre-Thoracic Surgery Respiratory Muscle Training vs Aerobic Exercise Training: A Systematic Review and Network Meta-analysis. Arch Phys Med Rehabil. 2023 May;104(5):790-798. doi: 10.1016/j.apmr.2022.10.015. Epub 2022 Dec 17. PMID 36539175
• Ferreira V, Lawson C, Ekmekjian T, Carli F, Scheede-Bergdahl C, Chevalier S. Effects of preoperative nutrition and multimodal prehabilitation on functional capacity and postoperative complications in surgical lung cancer patients: a systematic review. Support Care Cancer. 2021 Oct;29(10):5597-5610. doi: 10.1007/s00520-021-06161-5. Epub 2021 Mar 25. PMID 33768372
• Sebio Garcia R, Yanez Brage MI, Gimenez Moolhuyzen E, Granger CL, Denehy L. Functional and postoperative outcomes after preoperative exercise training in patients with lung cancer: a systematic review and meta-analysis. Interact Cardiovasc Thorac Surg. 2016 Sep;23(3):486-97. doi: 10.1093/icvts/ivw152. Epub 2016 May 25. PMID 27226400
• Cavalheri V, Granger CL. Exercise training as part of lung cancer therapy. Respirology. 2020 Nov;25 Suppl 2:80-87. doi: 10.1111/resp.13869. Epub 2020 Jun 1. PMID 32567236
• Cavalheri V, Granger C. Preoperative exercise training for patients with non-small cell lung cancer. Cochrane Database Syst Rev. 2017 Jun 7;6(6):CD012020. doi: 10.1002/14651858.CD012020.pub2. PMID 28589547

Идентификаторы

NCT: NCT06716437 · 30930

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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