Prehabilitation for Patients Undergoing Lung Cancer Surgery

NCT ID: NCT06716437

Last Updated: 2025-04-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-24
• Study Completion Date: 2025-06-30

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.

Conditions

Lung Cancer (NSCLC)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Prehabilitation arm

Patients will receive the prehabilitation program

Group Type: EXPERIMENTAL

Prehabilitation

Intervention Type: BEHAVIORAL

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 feedback iii) a home-based, unsupervised exercise program consisting of 10 whole body strengthening exercises delivered in a video format iv) an inspiratory muscle training program using a hand-held device to be performed twice daily.

Interventions

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 feedback iii) a home-based, unsupervised exercise program consisting of 10 whole body strengthening exercises delivered in a video format iv) an inspiratory muscle training program using a hand-held device to be performed twice daily.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Melbourne Health

OTHER

Sponsor Role: collaborator

St Vincent's Hospital Melbourne

OTHER

Sponsor Role: collaborator

University of Melbourne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Linda Denehy, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Melbourne

Locations

The University of Melbourne, Department of Physiotherapy

Parkville, Victoria, Australia

Site Status: RECRUITING

Countries

Australia

Central Contacts

Lara Edbrooke, PhD

Role: CONTACT

larae@unimelb.edu.au

+61 3 90354213

Raquel Sebio Gracia, PhD

Role: CONTACT

raquel.sebiogarcia@unimelb.edu.au

+ 34 679336288

Facility Contacts

Lara Edbrooke, PhD

Role: primary

larae@unimelb.edu.au

+61 3 9035 4213

Raquel Sebio Garcia, PhD

Role: backup

+34 679336288

References

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.

Reference Type: BACKGROUND

PMID: 32462351 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 36983146 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 36539175 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33768372 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27226400 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32567236 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28589547 (View on PubMed)

Other Identifiers

30930

Identifier Type: -

Identifier Source: org_study_id