Lung CancerNCT01068210
Lung Cancer Exercise Training Study
A study testing Aerobic Training, Progressive Stretching and Resistance Training in people with Lung Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The purpose of the study is look at the effects of different types of exercise training with a stretching group and its effect on lung cancer patients. Subjects will take part in a 16 week training intervention that can consist of aerobic, resistance, aerobic \& resistance, or a control group. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Aerobic Training, Progressive Stretching and Resistance Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to 29 Mar 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent prior to initiation of study-related procedures
- Age 21 - 80 years
- Weight < 205 kgs
- ECOG ≤ 1
- Diagnosed with histologically confirmed lung cancer, regardless of disease stage and receiving any prior line of any therapy in the context of metastatic disease
- An interval of at least three months following the completion of primary resection, if appropriate
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- An interval of no longer than ten years following completion of primary therapy, if appropriate
- Life expectancy ≥ 4 months
- Performing less than 150 minutes of structured moderate-intensity or strenuous-intensity exercise per week
- Exercise intolerance (i.e., patients must have a VO2peak below that predicted for active age and sex-matched individuals)
- Willing to be randomized to one of the study arms
- Willing to commit to the study program and comply with all related protocol procedures
- Able to achieve an acceptable peak baseline CPET, as defined by any of the following criteria:
- achieving a plateau in oxygen consumption, concurrent with an increase in power output;
- a respiratory exchange ratio ≥ 1.10;
- attainment of maximal predicted heart rate (HRmax) (i.e., within 10 bpm of age-predicted HRmax [HRmax = 220-Age[years]);
- volitional exhaustion, as measured by a rating of perceived exertion (RPE) ≥ 18 on the BORG scale.
- Able to complete an acceptable baseline CPET in the absence of high risk ECG findings or other inappropriate response to exercise as determined by the PI.
- Ability to achieve and complete an acceptable baseline one-repetition maximum muscular strength test as defined by the effective execution of protocol-specific joint and muscle ranges of motion without remarkable signs or symptoms of pain, discomfort or distress.
Who cannot join
- Presence of a concurrent, actively treated other malignancy, or history of other malignancy treated within the past 3 years (other than non-melanoma skin cancer);
- Room air desaturation at rest ≤ 85%;
- Mental impairment leading to inability to cooperate.
- Any of the following absolute contraindications to cardiopulmonary exercise testing:
- Acute myocardial infarction (within 3-5 days of any planned study procedures);
- Unstable angina;
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- Uncontrolled arrhythmia causing symptoms or hemodynamic compromise;
- Recurrent syncope;
- Active endocarditis;
- Acute myocarditis or pericarditis;
- Symptomatic severe aortic stenosis;
- Uncontrolled heart failure;
- Acute (within 3 months) pulmonary embolus or pulmonary infarction;
- Thrombosis of lower extremities;
- Suspected dissecting aneurysm;
- Uncontrolled asthma;
- Pulmonary edema;
- Respiratory failure;
- Acute non-cardiopulmonary disorders that may affect exercise performance or be aggravated by exercise (i.e., infection, renal failure, thyrotoxicosis)
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: Lung Cancer Exercise Training Study: A Randomized Trial of Aerobic Training, Resistance Training, or Both in Lung Cancer Patients
The purpose of the study is look at the effects of different types of exercise training with a stretching group and its effect on lung cancer patients. Subjects will take part in a 16 week training intervention that can consist of aerobic, resistance, aerobic \& resistance, or a control group. Pre and Post testing will include stress tests, echos, blood, and urine samples.
- Conditions
- Lung Cancer
- Being tested
- Aerobic Training, Progressive Stretching, Resistance Training, Aerobic and Resistance Training
- Keywords
- Exercise Intervention, Lung Cancer, 15-215
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic TrainingBehavioural
The overall goal for all the exercise training groups will be 3 supervised exercise sessions per week an intensity between 50 to 100% of the individually determined VO2peak for aerobic training and an intensity between 50% to 85% of 1-RM for resistance training. All the exercise interventions are designed such that participants begin exercising at a low intensity (~50%-60% VO2peak / 1RM) that is subsequently increased to more moderate to vigorous intensity (~70%-100% VO2peak / ~70-85% 1RM) when appropriate. All interventions will be individually tailored to each patient following the principles of aerobic or resistance training prescription guidelines for adults.
Progressive StretchingBehavioural
The ultimate goal for the progressive stretching program is 3 individual stretching sessions. All sessions are required to be supervised. Duration of the stretching sessions is prescribed and implemented in accordance with standard stretching and flexibility training principles. This approach will be applied to guide each participant's prescribed stretching plan, with dose and scheduling modifications made by exercise physiologists, as required.
Resistance TrainingBehavioural
The ultimate goal for resistance training alone is 3 resistance training session/week at an intensity above 50% to 85% of 1-RM for 30-60 minutes/session. Resistance trainings will be performed on stationary weight machines, modification in equipment may be made by Exercise Physiologist. Participants will be progressively trained to perform two to three sets of 75-85% of maximal strength.
Aerobic and Resistance TrainingBehavioural
The ultimate goal will be three combined exercise sessions per week at an intensity above 50% VO2speak and above 50% 1-RM for aerobic and resistance training, respectively for 30-90 minutes/session.
| Study group | Role | What they receive |
|---|---|---|
| Aerobic Training | Experimental | A customized and supervised endurance exercise training program that will last 4 months (16 weeks). The regimen will be tailored to the individual fitness level. The exercise program will consist of three supervised sessions per week. During each session, the participant will cycle on a stationary bicycle at moderate intensity for approximately 30-60 minutes. Receives: Behavioral: Aerobic Training |
| Resistance Training | Experimental | A customized and supervised resistance exercise training program that will last 4 months (16 weeks). Resistance training will be performed on stationary weight machines, modification in equipment may be made by Exercise Physiologist. Patients will be progressively trained to perform two to three sets of 75-85% of maximal strength The participant will be trained to perform different resistance exercise, alternating between lower and upper body muscle groups. The exercise program will consist of three supervised sessions per week. Each session will last approximately 30-60 minutes. Receives: Behavioral: Resistance Training |
| Combined Aerobic and Resistance Training | Experimental | A customized and supervised endurance exercise training program that will last 4 months (16 weeks). The regimen will be tailored to the individual fitness level, and will be a combination of Arm A and Arm B, described above. At each session, the participant will complete aerobic training on a stationary bicycle and also resistance training using stationary weight machines. The exercise program will consist of three supervised sessions per week. Each session will last approximately 30-90 minutes. Receives: Behavioral: Aerobic and Resistance Training |
| Progressive Stretching Group (Attention-Control) | Active comparator | A customized and supervised progressive stretching program that will last 4 months (16 weeks). The progressive stretching program will consist of a series of stretching exercises alternating between lower and upper body muscle groups/joints. This program will consist of three exercise sessions a week. Each session will last approximately 30-60 minutes. Receives: Behavioral: Progressive Stretching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in VO2peak (on Exercise Capacity)
To compare the efficacy of different types of exercise training modalities, relative to progressive stretching (attention control group)
Measured: 17 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2010 (estimated)
- Study startOct 2015
- Primary completion29 Mar 2024
- Study completion29 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Duke University
- Responsible party
- Sponsor
- Investigators
- Lee Jones, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01068210
- Sponsor's protocol ID
- 15-215
- Status last verified
- Mar 2025
- First submitted
- 11 Feb 2010
- Last updated
- 4 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Ernst M, Wagner C, Oeser A, Messer S, Wender A, Cryns N, Brockelmann PJ, Holtkamp U, Baumann FT, Wiskemann J, Monsef I, Scherer RW, Mishra SI, Skoetz N. Resistance training for fatigue in people with cancer. Cochrane Database Syst Rev. 2024 Nov 28;11(11):CD015518. doi: 10.1002/14651858.CD015518.
PubMed 39606939Scott JM, Thomas SM, Herndon JE 2nd, Douglas PS, Yu AF, Rusch V, Huang J, Capaci C, Harrison JN, Stoeckel KJ, Nilsen T, Edvardsen E, Michalski MG, Eves ND, Jones LW. Effects and tolerability of exercise therapy modality on cardiorespiratory fitness in lung cancer: a randomized controlled trial. J Cachexia Sarcopenia Muscle. 2021 Dec;12(6):1456-1465. doi: 10.1002/jcsm.12828. Epub 2021 Oct 17.
PubMed 34658160
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Cancer Exercise Training Study: A Randomized Trial of Aerobic Training, Resistance Training, or Both in Lung Cancer Patients
- ClinicalTrials.gov ID
- NCT01068210
- Acronym / sponsor ID
- 15-215
- Conditions
- Lung Cancer
- Keywords
- Exercise Intervention, Lung Cancer, 15-215
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Duke University
- Study start
- Oct 2015 (actual)
- Primary completion
- 29 Mar 2024 (actual)
- Study completion
- 29 Mar 2024 (actual)
- First posted
- 12 Feb 2010 (estimated)
- Results
- Posted 4 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is look at the effects of different types of exercise training with a stretching group and its effect on lung cancer patients. Subjects will take part in a 16 week training intervention that can consist of aerobic, resistance, aerobic \& resistance, or a control group. Pre and Post testing will include stress tests, echos, blood, and urine samples.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Aerobic Training | Experimental | Behavioral: Aerobic TrainingA customized and supervised endurance exercise training program that will last 4 months (16 weeks). The regimen will be tailored to the individual fitness level. The exercise program will consist of three supervised sessions per week. During each session, the participant will cycle on a stationary bicycle at moderate intensity for approximately 30-60 minutes. |
| Resistance Training | Experimental | Behavioral: Resistance TrainingA customized and supervised resistance exercise training program that will last 4 months (16 weeks). Resistance training will be performed on stationary weight machines, modification in equipment may be made by Exercise Physiologist. Patients will be progressively trained to perform two to three sets of 75-85% of maximal strength The participant will be trained to perform different resistance exercise, alternating between lower and upper body muscle groups. The exercise program will consist of three supervised sessions per week. Each session will last approximately 30-60 minutes. |
| Combined Aerobic and Resistance Training | Experimental | Behavioral: Aerobic and Resistance TrainingA customized and supervised endurance exercise training program that will last 4 months (16 weeks). The regimen will be tailored to the individual fitness level, and will be a combination of Arm A and Arm B, described above. At each session, the participant will complete aerobic training on a stationary bicycle and also resistance training using stationary weight machines. The exercise program will consist of three supervised sessions per week. Each session will last approximately 30-90 minutes. |
| Progressive Stretching Group (Attention-Control) | Active comparator | Behavioral: Progressive StretchingA customized and supervised progressive stretching program that will last 4 months (16 weeks). The progressive stretching program will consist of a series of stretching exercises alternating between lower and upper body muscle groups/joints. This program will consist of three exercise sessions a week. Each session will last approximately 30-60 minutes. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Signed informed consent prior to initiation of study-related procedures
- Age 21 - 80 years
- Weight < 205 kgs
- ECOG ≤ 1
- Diagnosed with histologically confirmed lung cancer, regardless of disease stage and receiving any prior line of any therapy in the context of metastatic disease
Key exclusion criteria (19 listed)
- Presence of a concurrent, actively treated other malignancy, or history of other malignancy treated within the past 3 years (other than non-melanoma skin cancer);
- Room air desaturation at rest ≤ 85%;
- Mental impairment leading to inability to cooperate.
- Any of the following absolute contraindications to cardiopulmonary exercise testing:
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 |
|---|---|---|
| Aerobic TrainingThe overall goal for all the exercise training groups will be 3 supervised exercise sessions per week an intensity between 50 to 100% of the individually determined VO2peak for aerobic training and an intensity between 50% to 85% of 1-RM for resistance training. All the exercise interventions are designed such that participants begin exercising at a low intensity (~50%-60% VO2peak / 1RM) that is subsequently increased to more moderate to vigorous intensity (~70%-100% VO2peak / ~70-85% 1RM) when appropriate. All interventions will be individually tailored to each patient following the principles of aerobic or resistance training prescription guidelines for adults. | Behavioural | Aerobic Training |
| Progressive StretchingThe ultimate goal for the progressive stretching program is 3 individual stretching sessions. All sessions are required to be supervised. Duration of the stretching sessions is prescribed and implemented in accordance with standard stretching and flexibility training principles. This approach will be applied to guide each participant's prescribed stretching plan, with dose and scheduling modifications made by exercise physiologists, as required. | Behavioural | Progressive Stretching Group (Attention-Control) |
| Resistance TrainingThe ultimate goal for resistance training alone is 3 resistance training session/week at an intensity above 50% to 85% of 1-RM for 30-60 minutes/session. Resistance trainings will be performed on stationary weight machines, modification in equipment may be made by Exercise Physiologist. Participants will be progressively trained to perform two to three sets of 75-85% of maximal strength. | Behavioural | Resistance Training |
| Aerobic and Resistance TrainingThe ultimate goal will be three combined exercise sessions per week at an intensity above 50% VO2speak and above 50% 1-RM for aerobic and resistance training, respectively for 30-90 minutes/session. | Behavioural | Combined Aerobic and Resistance Training |
Primary outcome
Changes in VO2peak (on Exercise Capacity)
Time frame: 17 weeks
To compare the efficacy of different types of exercise training modalities, relative to progressive stretching (attention control group)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39606939Ernst M, Wagner C, Oeser A, Messer S, Wender A, Cryns N, Brockelmann PJ, Holtkamp U, Baumann FT, Wiskemann J, Monsef I, Scherer RW, Mishra SI, Skoetz N. Resistance training for fatigue in people with cancer. Cochrane Database Syst Rev. 2024 Nov 28;11(11):CD015518. doi: 10.1002/14651858.CD015518.
- Derived from this study: PubMed 34658160Scott JM, Thomas SM, Herndon JE 2nd, Douglas PS, Yu AF, Rusch V, Huang J, Capaci C, Harrison JN, Stoeckel KJ, Nilsen T, Edvardsen E, Michalski MG, Eves ND, Jones LW. Effects and tolerability of exercise therapy modality on cardiorespiratory fitness in lung cancer: a randomized controlled trial. J Cachexia Sarcopenia Muscle. 2021 Dec;12(6):1456-1465. doi: 10.1002/jcsm.12828. Epub 2021 Oct 17.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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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.
Lee Jones, PhD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic Training, Progressive Stretching and Resistance Training in people with Lung Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
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 19 inclusion and 19 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 4 May 2025. 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 United States. 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?
Yes. Results are posted in the registry (first posted 4 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 VO2peak (on Exercise Capacity) (time frame: 17 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01068210, which also lists 2 linked publications.
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 4 May 2025.