Lung NeoplasmNCT05469425
Home-based Preoperative Exercise Training for Lung Cancer Patients Undergoing Surgery
A study testing Preoperative home-based exercise training in people with Lung Neoplasm, run by Instituto Politécnico de Leiria at 1 site in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Neoplasm
- What is being tested?
- Preoperative home-based exercise training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 sitePortugal
- Study dates
- 2 Sep 2022to 26 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Portugal1 site
Portuguese Oncology Institute of Coimbra
Coimbra, 3000-075 Coimbra
About this study
Official title: Effect of Home-based Preoperative Exercise Training on Quality of Life After Lung Cancer Surgery: A Randomized Controlled Trial
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.
Read more
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
- Being tested
- Preoperative home-based exercise training
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative home-based exercise trainingBehavioural
Home-based aerobic and resistance exercise training (preoperative period)
Dose of aerobic exercise:
- Type: Walking
- Frequency: 3 sessions per week
- Duration: 30 minutes
- Intensity: Rate of perceived exertion on Borg Category Ratio-10 (3-5)
- Progression: Increase the walking duration in 10 minutes (after week 2)
Dose of resistance exercise:
- Type: Six exercises for upper and lower limbs using bodyweight and free-wights of 1-2kg
- Frequency: 2 sessions per week
- Duration: 2 sets x 15 repetitions
- Rest in-between sets: 45 seconds
- Intensity: Rate of perceived exertion on Borg Category Ratio-10 (3-5)
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: Baseline to 3-5 weeks after surgery
Secondary outcomes (11)
Changes in exercise capacity
Will be assessed by the Incremental Shuttle Walk Test (ISWT). The ISWT measures the distance in meters an individual can walk around a 10 meters shuttle course paced according to an incremental speed dictated by an audio recording and was performed under the supervision of a single investigator using the protocol described by Singh et al. (1992). The test finished when the participant can no longer maintain the desired speed or became too breathless to continue.
Measured: Baseline to 2-3 days before surgery
Changes in exercise capacity
Will be assessed by the Incremental Shuttle Walk Test (ISWT). The ISWT measures the distance in meters an individual can walk around a 10 meters shuttle course paced according to an incremental speed dictated by an audio recording and was performed under the supervision of a single investigator using the protocol described by Singh et al. (1992). The test finished when the participant can no longer maintain the desired speed or became too breathless to continue.
Measured: Baseline to 3-5 weeks after surgery
Changes in handgrip strength
Will be assessed using the Hamar plus+ digital hand dynamometer. Measurements will be conducted using the standard position approved by the American Society of Hand Therapists. The standard adjustable handle dynamometer will be set at the second handle position for all patients. The non-tested arm will be resting neutrally and both feet were firmly on the ground, shoulder width apart. Patients will be instructed to grip the handle with maximal strength during 3 seconds and the measurements will be repeated three times for the left and right hand, with 30 seconds rest in-between measurements. The highest value for both hands (in kilograms) will be considered as the output measure to each patient.
Measured: Baseline to 2-3 days before surgery
Changes in handgrip strength
Will be assessed using the Hamar plus+ digital hand dynamometer. Measurements will be conducted using the standard position approved by the American Society of Hand Therapists. The standard adjustable handle dynamometer will be set at the second handle position for all patients. The non-tested arm will be resting neutrally and both feet were firmly on the ground, shoulder width apart. Patients will be instructed to grip the handle with maximal strength during 3 seconds and the measurements will be repeated three times for the left and right hand, with 30 seconds rest in-between measurements. The highest value for both hands (in kilograms) will be considered as the output measure to each patient.
Measured: Baseline to 3-5 weeks after surgery
Changes in five times sit to stand test
Patients will be instructed to perform the Five Times Sit to Stand Test (5STS) on a standardized armless chair (i.e., seating height between 41-45 cm, no elbow rests and wheels). After the cue "ready, set, go!", patients will start the STS repetitions as rapidly as possible from the sitting position with their buttocks touching the chair to the full standing position, with their arms crossed over the chest. The 5STS test will finish when the patients sit on the chair after the fifth repetition, and the time needed to complete the task will be recorded with a stopwatch to the nearest 0.01 s.
Measured: Baseline to 2-3 days before surgery
Changes in five times sit to stand test
Patients will be instructed to perform the Five Times Sit to Stand Test (5STS) on a standardized armless chair (i.e., seating height between 41-45 cm, no elbow rests and wheels). After the cue "ready, set, go!", patients will start the STS repetitions as rapidly as possible from the sitting position with their buttocks touching the chair to the full standing position, with their arms crossed over the chest. The 5STS test will finish when the patients sit on the chair after the fifth repetition, and the time needed to complete the task will be recorded with a stopwatch to the nearest 0.01 s.
Measured: Baseline to 3-5 weeks after surgery
Postoperative length of hospital stay
Defined as the number of days patients spend in the hospital after surgery. This will be collected from individual clinical records.
Measured: 3-6 days after surgery
Postoperative complications
Will be assessed using the Comprehensive Complication Index, that integrates all complications with their respective severities on a continuous scale ranging from 0 (no burden due to complications) to 100 (death as a result of complications).Postoperative complications were scored by severity using the scored by severity using the Clavien-Dindo classification.
Measured: 30 days after surgery
Adverse events
Defined as any unfavorable or unexpected event that occurred as a direct result of exercise training, during or within 24 hours after an exercise session. The severity of adverse events will be categorized based on the Common Terminology Criteria for Adverse Events (CTCAE), version 5. The CTCAE provides a grading (severity) scale, with each adverse event been classified as grade 1 (asymptomatic or mild symptoms, clinical or diagnostic observations only, and/or intervention not indicated) to grade 5 (death). An adverse event will be classified as "serious" if it resulted in hospitalization, persistent or significant disability, was life threatening, or resulted in death (i.e., grade 3 or higher).
Measured: Baseline to 2-3 days before surgery
Exercise attendance rate
Attendance rate will be defined as the ratio of total completed to planned exercise sessions, expressed as a percentage.
Measured: Baseline to 2-3 days before surgery
Exercise compliance rate
Compliance rate will be defined as the ratio of total completed to planned training volume, expressed as a percentage.
Measured: Baseline to 2-3 days before surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2022
- Study start2 Sep 2022
- Primary completion26 Jun 2023
- Study completion26 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Politécnico de Leiria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pedro Machado, Instituto Politécnico de Leiria
- Investigators
- Pedro FA Machado, Principal investigator, Center for Innovative Care and Health Technology, Polytechnic of Leiria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05469425
- Sponsor's protocol ID
- OncoEnergy
- Status last verified
- Jun 2023
- First submitted
- 13 Jul 2022
- Last updated
- 28 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Home-based Preoperative Exercise Training on Quality of Life After Lung Cancer Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05469425
- Acronym / sponsor ID
- OncoEnergy
- Conditions
- Lung Neoplasm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Instituto Politécnico de LeiriaUniversity, hospital or other
- Study start
- 2 Sep 2022 (actual)
- Primary completion
- 26 Jun 2023 (actual)
- Study completion
- 26 Jun 2023 (actual)
- First posted
- 21 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preoperative home-based exercise training | Experimental | Behavioral: Preoperative home-based exercise trainingPatients 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preoperative home-based exercise trainingHome-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. | Behavioural | Preoperative home-based exercise training |
Primary outcome
Changes in health-related quality of life
Time frame: Baseline to 2-3 days before surgery
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).
Changes in health-related quality of life
Time frame: Baseline to 3-5 weeks after surgery
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).
11 secondary outcomes
Changes in exercise capacity
Time frame: Baseline to 2-3 days before surgery
Changes in exercise capacity
Time frame: Baseline to 3-5 weeks after surgery
Changes in handgrip strength
Time frame: Baseline to 2-3 days before surgery
Changes in handgrip strength
Time frame: Baseline to 3-5 weeks after surgery
Changes in five times sit to stand test
Time frame: Baseline to 2-3 days before surgery
Changes in five times sit to stand test
Time frame: Baseline to 3-5 weeks after surgery
Postoperative length of hospital stay
Time frame: 3-6 days after surgery
Postoperative complications
Time frame: 30 days after surgery
Adverse events
Time frame: Baseline to 2-3 days before surgery
Exercise attendance rate
Time frame: Baseline to 2-3 days before surgery
Exercise compliance rate
Time frame: Baseline to 2-3 days before surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pedro FA Machado principal investigator
Center for Innovative Care and Health Technology, Polytechnic of Leiria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preoperative home-based exercise training in people with Lung Neoplasm, run by Instituto Politécnico de Leiria at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in health-related quality of life (time frame: Baseline to 2-3 days before surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2023.