Clinical trial NCT05469425: Home-based Preoperative Exercise Training for Lung Cancer Patients Undergoing Surgery
Official title: Effect of Home-based Preoperative Exercise Training on Quality of Life After Lung Cancer Surgery: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Neoplasm
Lead sponsor: Instituto Politécnico de Leiria
Sponsor class: OTHER
First posted: 2022-07-21
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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).

Primary outcomes:
measure: Changes in health-related quality of life
timeFrame: Baseline to 2-3 days before surgery
measure: Changes in health-related quality of life
timeFrame: Baseline to 3-5 weeks after surgery
Secondary outcomes:
measure: Changes in exercise capacity
timeFrame: Baseline to 2-3 days before surgery
measure: Changes in exercise capacity
timeFrame: Baseline to 3-5 weeks after surgery
measure: Changes in handgrip strength
timeFrame: Baseline to 2-3 days before surgery
measure: Changes in handgrip strength
timeFrame: Baseline to 3-5 weeks after surgery
measure: Changes in five times sit to stand test
timeFrame: Baseline to 2-3 days before surgery
measure: Changes in five times sit to stand test
timeFrame: Baseline to 3-5 weeks after surgery
measure: Postoperative length of hospital stay
timeFrame: 3-6 days after surgery
measure: Postoperative complications
timeFrame: 30 days after surgery
measure: Adverse events
timeFrame: Baseline to 2-3 days before surgery
measure: Exercise attendance rate
timeFrame: Baseline to 2-3 days before surgery
measure: Exercise compliance rate
timeFrame: Baseline to 2-3 days before surgery
Other outcomes:
Locations:
city: Coimbra
country: Portugal
facility: Portuguese Oncology Institute of Coimbra
Study officials:
affiliation: Center for Innovative Care and Health Technology, Polytechnic of Leiria
name: Pedro FA Machado
role: PRINCIPAL_INVESTIGATOR
References: