Lung CancerEarly Phase 1NCT01667237
Feasibility of a Short Home-based Rehabilitation Program for Cancer Patients Waiting for Lung Resection Surgery
A Early Phase 1 study testing Home-based pulmonary rehabilitation program in people with Lung Cancer, run by Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec at 1 site in Canada.
Trial summary
The general objectives of this study are to verify the feasibility of a short home-based rehabilitation program for cancer patients prior to lung resection surgery, and to quantify its effects on aerobic capacity, exercise tolerance and skeletal muscle strength. Therefore, the hypotheses of this study are that: 1. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Home-based pulmonary rehabilitation program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2010to Dec 2012
- Phase
- Early Phase 1
- 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 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Suffering from a non-small cell lung cancer on a waiting list for lung resection
- Having a VO2 Peak value of less than 20mL/kg/min.
Who cannot join
- SaO2 less less than 80% during the cardiopulmonary exercise test
- Contraindications to exercise testing (per American Thoracic Society/American College of Chest Physicians Exercise Testing Guidelines)
- A history of significant or cardiovascular disease, hypertension, diabetes, or musculoskeletal concerns that might limit the ability of these subjects to perform active exercises
- Severe psychiatric illness compromising training rehabilitation observance
Trial locations and contacts
1 site in 1 country.
About this study
The general objectives of this study are to verify the feasibility of a short home-based rehabilitation program for cancer patients prior to lung resection surgery, and to quantify its effects on aerobic capacity, exercise tolerance and skeletal muscle strength.
Therefore, the hypotheses of this study are that:
- Implementation of a short home-based rehabilitation program (4 weeks) based on exercise training is feasible and safe in patients with lung cancer resection candidates.
- Compared to control patients, patients included in the home-based rehabilitation program will improve significantly their aerobic capacity, exercise tolerance and arms and legs muscle force.
Read the detailed description
Being the leading cause of death from cancer, lung cancer represents a pressing health issue which generates significant social costs. In Canada, in 2009, an estimated 23 400 people will be diagnosed with lung cancer, and 20 500 will die from the disease. For people with localized non small cell lung cancer (NSCLC), lung resection surgery offers the best chance of curing the disease. In addition with lung cancer, these patients often experience such effects as a reduction in their exercise capacity and tolerance, muscle weakness, and decreased quality of life. Many researches demonstrated a link between a low exercise capacity and cardiopulmonary complications surrounding surgery. Therefore, the implementation of a preoperative pulmonary rehabilitation program, focused on improving aerobic capacity, could have significant positive outcomes, notably by reducing operative risks. The effectiveness of pulmonary rehabilitation, whether carried-out in a supervised setting or as a home-based program, is well recognized and such programs are included in guidelines for many pulmonary diseases. Despite these facts, few researches have studied its impact on lung cancer patients waiting for surgery. Moreover, not one have examined the feasibility and effectiveness of a home-based program for this population.
We plan to use that time waiting for surgery to increase exercise capacity and work tolerance of cancer patients waiting for surgery. Our expertise in pulmonary rehabilitation will prove to be invaluable to carry out this research project which objectives are to verify the feasibility of a short home-based rehabilitation program for cancer patients waiting for lung resection surgery, and to measure its effects on aerobic capacity, work tolerance and muscle strength.
In this way, we hope to contribute in developing innovative interventions that will assist the Canadian Lung Association's mission of improving the health of patients with respiratory problems. The results of this study will lead toward the development of a multicenter, randomized study that will be designed to verify the impact of such interventions on postoperative complications in this population.
Experimental design:
This pilot study will take place at the research center of the Institut de cardiologie et de pneumologie de Québec (IUCPQ), in collaboration with the thoracic surgery division and the Pavillon de Prevention des Maladies Cardiaques (PPMC). Once the lung cancer and surgical procedure considered by pneumologist, we will obtain the patient's consent and we will proceed to the initial assessment.
After the initial evaluation participants will undergo a 4-week home-based rehabilitation program under the supervision of an exercise specialist certified by the American College of Sport Medicine. Patients will be reevaluated after 4 weeks.
Preliminary screening: An initial screening, including maximal oxygen consumption assessment, will be performed under the supervision of a respiratory physician (Dr F. Maltais) to ensure that patients meet the all the inclusion and exclusion criteria of the study. In addition, a brief history of each patient's disease course and medication will be recorded.
Anthropometric measurements: Weight and height will be measured to determine the Body Mass Index (BMI). Body composition will be analyzed by bio-impedance (InBody 520, Biospace).
Quality of life and psychological distress: Generic quality-of-life questionnaires provide information on many aspects of a patient's life and can also be used to discriminate between patients within the same population. However, they are not as responsive to change as disease-specific questionnaires. Thus, generic quality-of-life assessment will be obtained at the time of enrolment. The SF-36 survey was selected for its ease of administration and because it is the most largely used questionnaire. A French version of the SF-36 is currently available. These data will be obtained only for descriptive analyses.
Pulmonary function tests: Standard pulmonary function tests including spirometry, lung volumes, and carbon monoxide diffusion capacity will be obtained for all subjects during the initial evaluation, according to previously described guidelines, and related to appropriate reference values.
Incremental cycle exercise test: In order to determine peak aerobic capacity and eligibility, and to quantify changes in exercise tolerance occurring with exercise training, an incremental exercise test will be performed (before inclusion). Patients will be seated on an electrically braked ergocycle (Quinton Corival 400; A-H Robins, Seattle, WA) and connected to the exercise circuit through a mouthpiece (Sensor Medics, Vpeak Legacy, Yorba Linda, CA). A progressive stepwise exercise test will be performed up to individual's peakimum capacity, using exercise steps of 1 minute and increments of 5-10 watts. Heart rate and oxygen saturation will be recorded using pulse oximetry and ECG, respectively. Symptoms of dyspnea and leg fatigue will be recorded using a modified Borg scale for perceived exertion52. Testing will take place under medical supervision, in the exercise physiology laboratory of IUCPQ research center.
Constant workrate cycle exercise test and 6-min walking test: A constant workrate cycle exercise test and a 6-min walking test will be performed to quantify changes in exercise tolerance occurring with exercise training.
- During the constant workrate cycle exercise test, patients will be asked to pedal at 80% max exercise work rate determined during the maximal test, and the time to exhaustion will be measured. Heart rate, dyspnea Borg score, and oxygen saturation will be monitored. Supplemental oxygen will be used if oxygen saturation < 90%.
- For the 6-min walking test, patients will also be asked to walk as far as possible for 6 minutes with standardized encouragement53. Two trials will be done and only the best one will be used for data analysis. Monitoring of respiratory and cardiac parameters, in addition to dyspnea and leg fatigue (modified Borg scale) will be done during the test.
Strength evaluation:
- Quadriceps strength will be assessed in two ways. First, by maximum voluntary contraction, and second, by measuring supramaximal twitch tension from a series of twitch following a magnetic stimulation (Magstim 200; Magstim Co.) of the femoral nerve as previously described. Generated force will be measured by an isometric force gauge while subjects will be in a standardized positioning. Validity and sensitivity of this equipment have previously been studied and we have used it in previous studies.
- Maximum voluntary contraction of the biceps brachii, deltoid and hamstring will be measured with a hand-held dynamometer (Microfet. Hoggan Inc, USA), using the method described and validated by Andrews and colleagues56. Finally, a maximum prehension strength will be assessed with a hydraulic dynamometer (Jamar).
- Conditions
- Lung Cancer
- Being tested
- Home-based pulmonary rehabilitation program
- Keywords
- Pulmonary rehabilitation program, Lung cancer, Lung resection surgery, Home-based
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based pulmonary rehabilitation programBehavioural
The rehabilitation program will be a self-monitored and minimally supervised home-exercise program. Exercise training modalities and intensity will be adapted to patient's individual condition. It will include aerobic and strength exercises 5 times a week for 4 weeks. Aerobic training will be done on a portable ergocycle. The target intensity will correspond to 60% of the maximal work rate achieved during the maximal progressive cardio-pulmonary exercise test, aiming for a cumulative time of 40 minutes per day. The heart rate, corresponding to an exercise level of 60% of max exercise capacity during the maximum exercise test, will be noted and patients will be instructed to train at this heart rate ± 10 beats. Muscle exercises will be performed using elastic bands and use of gravity.
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary rehabilitation | Experimental | Not described Receives: Behavioral: Home-based pulmonary rehabilitation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
To verify the feasability of a short home-based rehabilitation for cancer patients prior to lung resection surgery program.
Measured: During a 4 week rehabilitation programs preceeding surgery
Secondary outcomes (2)
To quantify the cycle endurance change induced by a short home-based rehabilitation for cancer patients prior to lung resection surgery program.
Measured: before and after a 4 week rehabilitation programs preceeding surgery
To quantify the quadriceps muscle force change induced by a short home-based rehabilitation for cancer patients prior to lung resection surgery program.
Measured: before and after a 4 week rehabilitation programs preceeding surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2012 (estimated)
- Study startMar 2010
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Didier Saey, Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
- Investigators
- Didier Saey, Phd., Principal investigator, Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01667237
- Sponsor's protocol ID
- 20525
- Status last verified
- Jan 2013
- First submitted
- 1 Jul 2010
- Last updated
- 10 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Short Home-based Rehabilitation Program for Cancer Patients Waiting for Lung Resection Surgery
- ClinicalTrials.gov ID
- NCT01667237
- Acronym / sponsor ID
- 20525
- Conditions
- Lung Cancer
- Keywords
- Pulmonary rehabilitation program, Lung cancer, Lung resection surgery, Home-based
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de QuebecUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 17 Aug 2012 (estimated)
- 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.
The general objectives of this study are to verify the feasibility of a short home-based rehabilitation program for cancer patients prior to lung resection surgery, and to quantify its effects on aerobic capacity, exercise tolerance and skeletal muscle strength.
Therefore, the hypotheses of this study are that:
- Implementation of a short home-based rehabilitation program (4 weeks) based on exercise training is feasible and safe in patients with lung cancer resection candidates.
- Compared to control patients, patients included in the home-based rehabilitation program will improve significantly their aerobic capacity, exercise tolerance and arms and legs muscle force.
Detailed description
Being the leading cause of death from cancer, lung cancer represents a pressing health issue which generates significant social costs. In Canada, in 2009, an estimated 23 400 people will be diagnosed with lung cancer, and 20 500 will die from the disease. For people with localized non small cell lung cancer (NSCLC), lung resection surgery offers the best chance of curing the disease. In addition with lung cancer, these patients often experience such effects as a reduction in their exercise capacity and tolerance, muscle weakness, and decreased quality of life. Many researches demonstrated a link between a low exercise capacity and cardiopulmonary complications surrounding surgery. Therefore, the implementation of a preoperative pulmonary rehabilitation program, focused on improving aerobic capacity, could have significant positive outcomes, notably by reducing operative risks. The effectiveness of pulmonary rehabilitation, whether carried-out in a supervised setting or as a home-based program, is well recognized and such programs are included in guidelines for many pulmonary diseases. Despite these facts, few researches have studied its impact on lung cancer patients waiting for surgery. Moreover, not one have examined the feasibility and effectiveness of a home-based program for this population.
We plan to use that time waiting for surgery to increase exercise capacity and work tolerance of cancer patients waiting for surgery. Our expertise in pulmonary rehabilitation will prove to be invaluable to carry out this research project which objectives are to verify the feasibility of a short home-based rehabilitation program for cancer patients waiting for lung resection surgery, and to measure its effects on aerobic capacity, work tolerance and muscle strength.
In this way, we hope to contribute in developing innovative interventions that will assist the Canadian Lung Association's mission of improving the health of patients with respiratory problems. The results of this study will lead toward the development of a multicenter, randomized study that will be designed to verify the impact of such interventions on postoperative complications in this population.
Experimental design:
This pilot study will take place at the research center of the Institut de cardiologie et de pneumologie de Québec (IUCPQ), in collaboration with the thoracic surgery division and the Pavillon de Prevention des Maladies Cardiaques (PPMC). Once the lung cancer and surgical procedure considered by pneumologist, we will obtain the patient's consent and we will proceed to the initial assessment.
After the initial evaluation participants will undergo a 4-week home-based rehabilitation program under the supervision of an exercise specialist certified by the American College of Sport Medicine. Patients will be reevaluated after 4 weeks.
Preliminary screening: An initial screening, including maximal oxygen consumption assessment, will be performed under the supervision of a respiratory physician (Dr F. Maltais) to ensure that patients meet the all the inclusion and exclusion criteria of the study. In addition, a brief history of each patient's disease course and medication will be recorded.
Anthropometric measurements: Weight and height will be measured to determine the Body Mass Index (BMI). Body composition will be analyzed by bio-impedance (InBody 520, Biospace).
Quality of life and psychological distress: Generic quality-of-life questionnaires provide information on many aspects of a patient's life and can also be used to discriminate between patients within the same population. However, they are not as responsive to change as disease-specific questionnaires. Thus, generic quality-of-life assessment will be obtained at the time of enrolment. The SF-36 survey was selected for its ease of administration and because it is the most largely used questionnaire. A French version of the SF-36 is currently available. These data will be obtained only for descriptive analyses.
Pulmonary function tests: Standard pulmonary function tests including spirometry, lung volumes, and carbon monoxide diffusion capacity will be obtained for all subjects during the initial evaluation, according to previously described guidelines, and related to appropriate reference values.
Incremental cycle exercise test: In order to determine peak aerobic capacity and eligibility, and to quantify changes in exercise tolerance occurring with exercise training, an incremental exercise test will be performed (before inclusion). Patients will be seated on an electrically braked ergocycle (Quinton Corival 400; A-H Robins, Seattle, WA) and connected to the exercise circuit through a mouthpiece (Sensor Medics, Vpeak Legacy, Yorba Linda, CA). A progressive stepwise exercise test will be performed up to individual's peakimum capacity, using exercise steps of 1 minute and increments of 5-10 watts. Heart rate and oxygen saturation will be recorded using pulse oximetry and ECG, respectively. Symptoms of dyspnea and leg fatigue will be recorded using a modified Borg scale for perceived exertion52. Testing will take place under medical supervision, in the exercise physiology laboratory of IUCPQ research center.
Constant workrate cycle exercise test and 6-min walking test: A constant workrate cycle exercise test and a 6-min walking test will be performed to quantify changes in exercise tolerance occurring with exercise training.
- During the constant workrate cycle exercise test, patients will be asked to pedal at 80% max exercise work rate determined during the maximal test, and the time to exhaustion will be measured. Heart rate, dyspnea Borg score, and oxygen saturation will be monitored. Supplemental oxygen will be used if oxygen saturation < 90%.
- For the 6-min walking test, patients will also be asked to walk as far as possible for 6 minutes with standardized encouragement53. Two trials will be done and only the best one will be used for data analysis. Monitoring of respiratory and cardiac parameters, in addition to dyspnea and leg fatigue (modified Borg scale) will be done during the test.
Strength evaluation:
- Quadriceps strength will be assessed in two ways. First, by maximum voluntary contraction, and second, by measuring supramaximal twitch tension from a series of twitch following a magnetic stimulation (Magstim 200; Magstim Co.) of the femoral nerve as previously described. Generated force will be measured by an isometric force gauge while subjects will be in a standardized positioning. Validity and sensitivity of this equipment have previously been studied and we have used it in previous studies.
- Maximum voluntary contraction of the biceps brachii, deltoid and hamstring will be measured with a hand-held dynamometer (Microfet. Hoggan Inc, USA), using the method described and validated by Andrews and colleagues56. Finally, a maximum prehension strength will be assessed with a hydraulic dynamometer (Jamar).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pulmonary rehabilitation | Experimental | Behavioral: Home-based pulmonary rehabilitation program |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Suffering from a non-small cell lung cancer on a waiting list for lung resection
- Having a VO2 Peak value of less than 20mL/kg/min.
Key exclusion criteria (4 listed)
- SaO2 less less than 80% during the cardiopulmonary exercise test
- Contraindications to exercise testing (per American Thoracic Society/American College of Chest Physicians Exercise Testing Guidelines)
- A history of significant or cardiovascular disease, hypertension, diabetes, or musculoskeletal concerns that might limit the ability of these subjects to perform active exercises
- Severe psychiatric illness compromising training rehabilitation observance
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 |
|---|---|---|
| Home-based pulmonary rehabilitation programThe rehabilitation program will be a self-monitored and minimally supervised home-exercise program. Exercise training modalities and intensity will be adapted to patient's individual condition. It will include aerobic and strength exercises 5 times a week for 4 weeks. Aerobic training will be done on a portable ergocycle. The target intensity will correspond to 60% of the maximal work rate achieved during the maximal progressive cardio-pulmonary exercise test, aiming for a cumulative time of 40 minutes per day. The heart rate, corresponding to an exercise level of 60% of max exercise capacity during the maximum exercise test, will be noted and patients will be instructed to train at this heart rate ± 10 beats. Muscle exercises will be performed using elastic bands and use of gravity. | Behavioural | Pulmonary rehabilitation |
Primary outcome
To verify the feasability of a short home-based rehabilitation for cancer patients prior to lung resection surgery program.
Time frame: During a 4 week rehabilitation programs preceeding surgery
2 secondary outcomes
To quantify the cycle endurance change induced by a short home-based rehabilitation for cancer patients prior to lung resection surgery program.
Time frame: before and after a 4 week rehabilitation programs preceeding surgery
To quantify the quadriceps muscle force change induced by a short home-based rehabilitation for cancer patients prior to lung resection surgery program.
Time frame: before and after a 4 week rehabilitation programs preceeding 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 10 Jan 2013.
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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.
Didier Saey, Phd. principal investigator
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Home-based pulmonary rehabilitation program in people with Lung Cancer, run by Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec at 1 site in Canada.
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 2 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 10 Jan 2013. 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 Canada. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
To verify the feasability of a short home-based rehabilitation for cancer patients prior to lung resection surgery program. (time frame: During a 4 week rehabilitation programs preceeding surgery). 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 10 Jan 2013.