N/A
N=90
Lung Cancer Exercise Training Study
Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01068210 ↗Enrolled (actual)
90
Serious AEs
0.0%
Results posted
May 2025
Primary outcome: Primary: Changes in VO2peak (on Exercise Capacity) — 17.9; 15.2; 15.2; 14.5 mL/kg/min
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Aerobic Training (Behavioral); Progressive Stretching (Behavioral); Resistance Training (Behavioral); Aerobic and Resistance Training (Behavioral)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Primary completion
- Mar 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in VO2peak (on Exercise Capacity) |
17.9; 15.2; 15.2; 14.5; 19.2; 15.2 | — |
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. Pre and Post testing will include stress tests, echos, blood, and urine samples.
Eligibility Criteria
Inclusion Criteria
- 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
- 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.
Exclusion Criteria
- 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;
- 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)
Data sourced from ClinicalTrials.gov (NCT01068210). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.