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

NCT ID: NCT05469425

Last Updated: 2023-06-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-02
• Study Completion Date: 2023-06-26

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.

Conditions

Lung Neoplasm

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Preoperative home-based exercise training

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.

Group Type: EXPERIMENTAL

Preoperative home-based exercise training

Intervention Type: BEHAVIORAL

Home-based aerobic and resistance exercise training (preoperative period)

Dose of aerobic exercise:

1. Type: Walking

2. Frequency: 3 sessions per week

3. Duration: 30 minutes

4. Intensity: Rate of perceived exertion on Borg Category Ratio-10 (3-5)

5. Progression: Increase the walking duration in 10 minutes (after week 2)

Dose of resistance exercise:

1. Type: Six exercises for upper and lower limbs using bodyweight and free-wights of 1-2kg

2. Frequency: 2 sessions per week

3. Duration: 2 sets x 15 repetitions

4. Rest in-between sets: 45 seconds

5. Intensity: Rate of perceived exertion on Borg Category Ratio-10 (3-5)

6. Progression: Increase the number of sets (3 sets of 15 repetitions after week 2)

Weekly telephone supervision: A physical therapist will carry out weekly telephone calls with all participants to monitor adverse events and recommend strategies to overcome barriers that arise during the exercise program.

Control Group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Preoperative home-based exercise training

Home-based aerobic and resistance exercise training (preoperative period)

Dose of aerobic exercise:

1. Type: Walking

2. Frequency: 3 sessions per week

3. Duration: 30 minutes

4. Intensity: Rate of perceived exertion on Borg Category Ratio-10 (3-5)

5. Progression: Increase the walking duration in 10 minutes (after week 2)

Dose of resistance exercise:

1. Type: Six exercises for upper and lower limbs using bodyweight and free-wights of 1-2kg

2. Frequency: 2 sessions per week

3. Duration: 2 sets x 15 repetitions

4. Rest in-between sets: 45 seconds

5. Intensity: Rate of perceived exertion on Borg Category Ratio-10 (3-5)

6. Progression: Increase the number of sets (3 sets of 15 repetitions after week 2)

Weekly telephone supervision: A physical therapist will carry out weekly telephone calls with all participants to monitor adverse events and recommend strategies to overcome barriers that arise during the exercise program.

Intervention Type: BEHAVIORAL

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).

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

Sponsors

Instituto Politécnico de Leiria

OTHER

Sponsor Role: lead

Responsible Party

Pedro Machado

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pedro FA Machado

Role: PRINCIPAL_INVESTIGATOR

Center for Innovative Care and Health Technology, Polytechnic of Leiria

Locations

Portuguese Oncology Institute of Coimbra

Coimbra, , Portugal

Countries

Portugal

Other Identifiers

OncoEnergy

Identifier Type: -

Identifier Source: org_study_id