Clinical trial NCT06716437: Prehabilitation for Patients Undergoing Lung Cancer Surgery
Official title: Digitally Enabled Prehabilitation in a Community-based Setting for Patients Undergoing Lung Cancer Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Cancer (NSCLC)
Keywords: Prehabilitation
Inspiratory Muscle Training
Exercise Therapy
Lung Cancer
Telehealth
Lead sponsor: University of Melbourne
Sponsor class: OTHER
Collaborators: name: Melbourne Health
name: St Vincent's Hospital Melbourne
First posted: 2024-12-04
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Feasibility of the intervention
timeFrame: From enrollment to the end of the study approximately one week after surgery
measure: App usability and acceptability
timeFrame: Within one week before surgery
Secondary outcomes:
measure: Safety of the intervention
timeFrame: From enrollment to the end of the program before surgery
measure: Inspiratory Muscle Strength
timeFrame: Within one week before surgery
measure: Diaphragmatic excursion and thickness
timeFrame: Within one week before surgery
measure: Lung function
timeFrame: Within one week before surgery
measure: Self-efficacy
timeFrame: Within one week before surgery
measure: Participant satisfaction
timeFrame: Within one week before surgery
measure: Health Related Quality of Life
timeFrame: Within one week before surgery
measure: Recovery from surgery
timeFrame: Within one week before surgery
Other outcomes:
Locations:
city: Parkville
country: Australia
facility: The University of Melbourne, Department of Physiotherapy
state: Victoria
Study officials:
affiliation: University of Melbourne
name: Linda Denehy, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.