AzTrials
AzTrials

Lung NeoplasmNCT05473052

Home-based Exercise Training for Lung Cancer Patients Awaiting 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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Surgical resection is the only curative treatment in patients diagnosed with lung cancer, the most mortal type of malignancy globally. However, following lung cancer resection, patients experience a substantial deterioration in health-related quality of life and have an increased risk of developing pulmonary… 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
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 sitePortugal
Study dates
1 Feb 2022to 1 Jul 2022
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

Other trials in Portugal

About this study

Official title: Home-based Preoperative Exercise Training for Lung Cancer Patients Undergoing Surgery: A Feasibility Trial

Surgical resection is the only curative treatment in patients diagnosed with lung cancer, the most mortal type of malignancy globally. However, following lung cancer resection, patients experience a substantial deterioration in health-related quality of life and have an increased risk of developing pulmonary complications.

Although current clinical guidelines strongly recommend preoperative exercise training to improve clinical outcomes after lung cancer surgery, inaccessibility to facility-based exercise programs is a major barrier to routine participation, with patients indicating a strong preference to exercise in a home-based environment.

The primary purpose of the present study was to evaluate the feasibility of a home-based exercise program (HBEP) in lung cancer patients awaiting surgical treatment. The secondary purposes were to evaluate the safety of the HBEP and to explore exercise effects on patients' HRQOL and physical performance, either pre-and post-surgery.

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

    1. 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
    7. Weekly telephone supervision: A physical therapist carried out weekly telephone calls with all participants to monitor adverse events, give positive reinforcement and recommend strategies to overcome barriers that arise during the exercise program.
Study groups in NCT05473052
Study groupRoleWhat they receive
Preoperative home-based exercise trainingExperimentalPatients received usual care plus a preoperative home-based exercise program consisting of aerobic and resistance exercise. In addition, a physical therapist carried out weekly telephone supervision with all participants
Receives: Behavioral: Preoperative home-based exercise training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recruitment rate

    Defined as the ratio of recruited patients to those who were eligible, expressed as a percentage.

    Measured: Baseline

  2. Retention rate

    Defined as the ratio of patients who completed the study to those who were recruited, expressed as a percentage

    Measured: Baseline to 4-5 weeks after surgery

  3. 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

  4. 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

Secondary outcomes (9)
  1. 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 was 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 was 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

  2. Changes in exercise capacity

    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

  3. Changes in exercise capacity

    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 4-5 weeks after surgery.

  4. Changes in health-related quality of life

    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, was assessed the 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

  5. Changes in health-related quality of life

    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, was assessed the 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 4-5 weeks after surgery

  6. Changes in handgrip strength

    Assessed using a Jamar hydraulic hand dynamometer (JA Preston Corporation, Jackson, MI, USA). Measurements were conducted using the standard position approved by the American Society of Hand Therapists. The standard adjustable handle dynamometer was set at the second handle position for all patients. The non-tested arm was resting neutrally and both feet were firmly on the ground, shoulder width apart. Patients were instructed to grip the handle with maximal strength during 3 seconds and the measurements were repeated three times for the left and right hand, with 30 seconds rest in-between measurements. The highest value for both hands (in kilograms) was considered as the output measure to each patient.

    Measured: Baseline to 2-3 days before surgery

  7. Changes in handgrip strength

    Assessed using a Jamar hydraulic hand dynamometer (JA Preston Corporation, Jackson, MI, USA). Measurements were conducted using the standard position approved by the American Society of Hand Therapists. The standard adjustable handle dynamometer was set at the second handle position for all patients. The non-tested arm was resting neutrally and both feet were firmly on the ground, shoulder width apart. Patients were instructed to grip the handle with maximal strength during 3 seconds and the measurements were repeated three times for the left and right hand, with 30 seconds rest in-between measurements. The highest value for both hands (in kilograms) was considered as the output measure to each patient.

    Measured: Baseline to 4-5 weeks after surgery

  8. Changes in five times sit to stand test

    Patients were 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 started 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 finished when the patients sit on the chair after the fifth repetition, and the time needed to complete the task was recorded with a stopwatch to the nearest 0.01 s.

    Measured: Baseline to 2-3 days before surgery

  9. Changes in five times sit to stand test

    Patients were 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 started 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 finished when the patients sit on the chair after the fifth repetition, and the time needed to complete the task was recorded with a stopwatch to the nearest 0.01 s.

    Measured: Baseline to 4-5 weeks after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jul 2022
  2. Study start1 Feb 2022
  3. Primary completion1 Jul 2022
  4. Study completion1 Jul 2022

Resources

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
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05473052
Sponsor's protocol ID
HomeFittosurgery
Status last verified
Jul 2022
First submitted
22 Jul 2022
Last updated
25 Jul 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

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 25 Jul 2022. 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?

Recruitment rate (time frame: Baseline). The study lists 4 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 25 Jul 2022.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in