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

NCT05469425 | Completed

• 1 other identifier: OncoEnergy
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Changes in health-related quality of life

  Will be assessed through the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire C30 (QLQ-C30) (version 3.0). The QLQ-C30 is composed of 30 questions, including five multi-item functioning scales, three multi-item symptom scales, six single-item symptom scales, and a two-item global health status scale \[GHS\]. Scores range from 0 to 100 points, with a higher score on the functioning scales indicating a higher level of functioning, whereas a higher score on the symptom scales indicates a higher level of symptom burden. In addition, the investigators will assess EORTC QLQ-C30 summary score (SumSc) because it provides a psychometrically more robust alternative to the GHS score that is frequently used as the primary HRQOL endpoint in clinical trials. The SumSc is calculated from the mean of 13 of the 15 QLQ-C30 scores (the GHS and financial impact scales are excluded).

  Baseline to 2-3 days before surgery

• Changes in health-related quality of life

  Will be assessed through the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire C30 (QLQ-C30) (version 3.0). The QLQ-C30 is composed of 30 questions, including five multi-item functioning scales, three multi-item symptom scales, six single-item symptom scales, and a two-item global health status scale \[GHS\]. Scores range from 0 to 100 points, with a higher score on the functioning scales indicating a higher level of functioning, whereas a higher score on the symptom scales indicates a higher level of symptom burden. In addition, the investigators will assess EORTC QLQ-C30 summary score (SumSc) because it provides a psychometrically more robust alternative to the GHS score that is frequently used as the primary HRQOL endpoint in clinical trials. The SumSc is calculated from the mean of 13 of the 15 QLQ-C30 scores (the GHS and financial impact scales are excluded).

  Baseline to 3-5 weeks after surgery

Secondary Outcomes (11)

• Changes in exercise capacity

  Baseline to 2-3 days before surgery

• Changes in exercise capacity

  Baseline to 3-5 weeks after surgery

• Changes in handgrip strength

  Baseline to 2-3 days before surgery

• Changes in handgrip strength

  Baseline to 3-5 weeks after surgery

• Changes in five times sit to stand test

  Baseline to 2-3 days before surgery

Study Arms (2)

Preoperative home-based exercise training

EXPERIMENTAL

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.

Behavioral: Preoperative home-based exercise training

Control Group

NO INTERVENTION

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.

Interventions

Preoperative home-based exercise training 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.

Preoperative home-based exercise training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Instituto Politécnico de Leiria: lead

Study Sites (1)

Portuguese Oncology Institute of Coimbra

Coimbra, 3000-075 Coimbra, Portugal

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Pedro FA Machado

  Center for Innovative Care and Health Technology, Polytechnic of Leiria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 13, 2022
• First Posted: July 21, 2022
• Study Start: September 2, 2022
• Primary Completion: June 26, 2023
• Study Completion: June 26, 2023
• Last Updated: June 28, 2023

Record last verified: 2023-06

Locations

PT (1)