Home-based Preoperative Exercise Training for Lung Cancer Patients Undergoing Surgery

Instituto Politécnico de Leiria

Status: Completed

Conditions: Lung Neoplasm

Treatments: Behavioral: Preoperative home-based exercise training

Study type: Interventional

Funder types: Other

Identifiers

NCT05469425

OncoEnergy

Details and patient eligibility

About

Lung cancer accounts for over 11% of global cancer incidence and is the leading cause of cancer death, with numbers in 2020 reaching 1.8 million deaths worldwide.

For early-stage lung cancer patients, surgical resection is the recommended treatment and the intervention associated with a better prognosis. However, in consequence of surgery there is a substantial deterioration in health-related quality of life across most dimensions, especially in the first month, with 100% of lung cancer patients concerned about the limitations in their physical function and 96% about the levels of fatigue and pain after lobectomy.

Additionally, some patients developed postoperative pulmonary complications, which are associated with increased length of hospital stay and higher risk of mortality.

In this context, and considering that the number of lung cancer cases with an indication for surgery will increase by 60% from 2018 to 2040, to find feasible and effective interventions that could optimize postoperative recovery is of major clinical relevance.

The primary purpose of this study will be to evaluate the efficacy of home-based preoperative exercise training to improve health-related quality of life after lung cancer surgery. The secondary purpose of this study will be to evaluate the efficacy of the home-based exercise program to improve physical performance and to reduce postoperative complications /length of hospital stay. Participants will be randomly allocated to a preoperative exercise intervention, that will consist of combined aerobic and resistance exercise, or to a control group that will receive usual care (i.e., no exercise training).

Based on the strong evidence indicating a therapeutic effect of exercise training on fatigue and physical function, domains of HRQOL especially affected after lung cancer surgery, the investigators hypothesized that the home-based exercise program will be effective to improve these domains before surgery and attenuate its deterioration after surgery, optimizing the recovery in postoperative HRQOL.

Enrollment: 46 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Scheduled for surgical treatment of suspected or confirmed lung cancer (clinical stage IIIA or less)
• Waiting time for surgery of at least two weeks from baseline assessment
• Medical clearance to exercise.
• Signed informed consent prior to initiation of study-related procedures

Exclusion criteria

• Metastatic cancer
• Presence of physical or mental disabilities that contraindicated exercise training or physical testing
• Unable to communicate in Portuguese or English
• Performing combined aerobic plus resistance training over the past month (self-reported ≥2 days a week, ≥30 minutes each session).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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46 participants in 2 patient groups

Preoperative home-based exercise training

Experimental group

Description:

Patients allocated to this group will receive usual care plus a preoperative home-based exercise program consisting of aerobic and resistance exercise. In addition, a physical therapist will carry out weekly telephone supervision with all participants.

Treatment:

Behavioral: Preoperative home-based exercise training

Control Group

No Intervention group

Description:

Patients allocated to this group will receive usual care and must complete the outcome measures. In addition, a physical therapist will carry out weekly telephone calls with all participants to monitor adverse events.