Lung Cancer
Conditions
Keywords
Exercise Intervention, Lung Cancer, 15-215
Brief 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.
Interventions
BEHAVIORALAerobic Training
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.
BEHAVIORALProgressive Stretching
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.
BEHAVIORALResistance Training
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.
BEHAVIORALAerobic and Resistance Training
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.
Sponsors
National Cancer Institute (NCI)
Duke University
Memorial Sloan Kettering Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in VO2peak (on Exercise Capacity) | 17 weeks | To compare the efficacy of different types of exercise training modalities, relative to progressive stretching (attention control group) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Aerobic Training 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.
Aerobic Training: 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. | 24 |
| Resistance Training 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.
Resistance Training: 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. | 23 |
| Combined Aerobic and Resistance Training 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.
Aerobic and Resistance Training: 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. | 20 |
| Progressive Stretching Group (Attention-Control) 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.
Progressive Stretching: 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. | 23 |
| Total | 90 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Disease progression | 0 | 0 | 0 | 2 |
| Overall Study | Lost to Follow-up | 1 | 2 | 2 | 1 |
| Overall Study | Second cancer | 0 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Aerobic Training | Total | Progressive Stretching Group (Attention-Control) | Combined Aerobic and Resistance Training | Resistance Training |
|---|---|---|---|---|---|
| Age, Continuous | 65 years | 65 years | 67 years | 63 years | 64 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 20 Participants | 78 Participants | 19 Participants | 19 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants | 11 Participants | 4 Participants | 1 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 4 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 15 Participants | 3 Participants | 2 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 20 Participants | 71 Participants | 19 Participants | 18 Participants | 14 Participants |
| Region of Enrollment United States | 24 participants | 90 participants | 23 participants | 20 participants | 23 participants |
| Sex: Female, Male Female | 15 Participants | 59 Participants | 16 Participants | 13 Participants | 15 Participants |
| Sex: Female, Male Male | 9 Participants | 31 Participants | 7 Participants | 7 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 0 / 23 | 0 / 20 | 0 / 23 |
| other Total, other adverse events | 8 / 24 | 15 / 23 | 12 / 20 | 3 / 23 |
| serious Total, serious adverse events | 0 / 24 | 0 / 23 | 0 / 20 | 0 / 23 |
Outcome results
Primary
Changes in VO2peak (on Exercise Capacity)
To compare the efficacy of different types of exercise training modalities, relative to progressive stretching (attention control group)
Time frame: 17 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aerobic Training | Changes in VO2peak (on Exercise Capacity) | Baseline | 17.9 mL/kg/min | Standard Deviation 5.5 |
| Aerobic Training | Changes in VO2peak (on Exercise Capacity) | Follow up | 19.2 mL/kg/min | Standard Deviation 5.6 |
| Resistance Training | Changes in VO2peak (on Exercise Capacity) | Follow up | 15.2 mL/kg/min | Standard Deviation 3.8 |
| Resistance Training | Changes in VO2peak (on Exercise Capacity) | Baseline | 15.2 mL/kg/min | Standard Deviation 3.2 |
| Combined Aerobic and Resistance Training | Changes in VO2peak (on Exercise Capacity) | Baseline | 15.2 mL/kg/min | Standard Deviation 4.5 |
| Combined Aerobic and Resistance Training | Changes in VO2peak (on Exercise Capacity) | Follow up | 16.5 mL/kg/min | Standard Deviation 5.5 |
| Progressive Stretching Group (Attention-Control) | Changes in VO2peak (on Exercise Capacity) | Baseline | 14.5 mL/kg/min | Standard Deviation 4.1 |
| Progressive Stretching Group (Attention-Control) | Changes in VO2peak (on Exercise Capacity) | Follow up | 14.5 mL/kg/min | Standard Deviation 4.1 |