Trial Outcomes & Findings for Lung Cancer Exercise Training Study (NCT NCT01068210)
NCT ID: NCT01068210
Last Updated: 2025-05-04
Results Overview
To compare the efficacy of different types of exercise training modalities, relative to progressive stretching (attention control group)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
110 participants
Primary outcome timeframe
17 weeks
Results posted on
2025-05-04
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
24
|
23
|
20
|
23
|
|
Overall Study
COMPLETED
|
23
|
20
|
18
|
20
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
2
|
3
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
2
|
1
|
|
Overall Study
Second cancer
|
0
|
1
|
0
|
0
|
|
Overall Study
Disease progression
|
0
|
0
|
0
|
2
|
Baseline Characteristics
Lung Cancer Exercise Training Study
Baseline characteristics by cohort
| Measure |
Aerobic Training
n=24 Participants
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.
|
Resistance Training
n=23 Participants
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.
|
Combined Aerobic and Resistance Training
n=20 Participants
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.
|
Progressive Stretching Group (Attention-Control)
n=23 Participants
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.
|
Total
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
65 years
n=5 Participants
|
64 years
n=7 Participants
|
63 years
n=5 Participants
|
67 years
n=4 Participants
|
65 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
59 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
31 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
78 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
71 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=5 Participants
|
23 participants
n=7 Participants
|
20 participants
n=5 Participants
|
23 participants
n=4 Participants
|
90 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 17 weeksTo compare the efficacy of different types of exercise training modalities, relative to progressive stretching (attention control group)
Outcome measures
| Measure |
Aerobic Training
n=24 Participants
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.
|
Resistance Training
n=23 Participants
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.
|
Combined Aerobic and Resistance Training
n=20 Participants
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.
|
Progressive Stretching Group (Attention-Control)
n=23 Participants
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.
|
|---|---|---|---|---|
|
Changes in VO2peak (on Exercise Capacity)
Baseline
|
17.9 mL/kg/min
Standard Deviation 5.5
|
15.2 mL/kg/min
Standard Deviation 3.2
|
15.2 mL/kg/min
Standard Deviation 4.5
|
14.5 mL/kg/min
Standard Deviation 4.1
|
|
Changes in VO2peak (on Exercise Capacity)
Follow up
|
19.2 mL/kg/min
Standard Deviation 5.6
|
15.2 mL/kg/min
Standard Deviation 3.8
|
16.5 mL/kg/min
Standard Deviation 5.5
|
14.5 mL/kg/min
Standard Deviation 4.1
|
Adverse Events
Aerobic Training
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Resistance Training
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Combined Aerobic and Resistance Training
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Progressive Stretching Group (Attention-Control)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Aerobic Training
n=24 participants at risk
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.
Exercise 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.
|
Resistance Training
n=23 participants at risk
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.
Exercise 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.
|
Combined Aerobic and Resistance Training
n=20 participants at risk
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.
Exercise 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.
|
Progressive Stretching Group (Attention-Control)
n=23 participants at risk
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.
|
|---|---|---|---|---|
|
Cardiac disorders
Abnormal heart rate response
|
4.2%
1/24 • 17 weeks
|
0.00%
0/23 • 17 weeks
|
0.00%
0/20 • 17 weeks
|
0.00%
0/23 • 17 weeks
|
|
Vascular disorders
Abnormal blood pressure response
|
0.00%
0/24 • 17 weeks
|
4.3%
1/23 • 17 weeks
|
0.00%
0/20 • 17 weeks
|
0.00%
0/23 • 17 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.5%
3/24 • 17 weeks
|
65.2%
15/23 • 17 weeks
|
60.0%
12/20 • 17 weeks
|
13.0%
3/23 • 17 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
25.0%
6/24 • 17 weeks
|
17.4%
4/23 • 17 weeks
|
25.0%
5/20 • 17 weeks
|
8.7%
2/23 • 17 weeks
|
|
Cardiac disorders
Electrocardiogram abnormalities
|
4.2%
1/24 • 17 weeks
|
4.3%
1/23 • 17 weeks
|
5.0%
1/20 • 17 weeks
|
0.00%
0/23 • 17 weeks
|
|
Nervous system disorders
Dizziness
|
12.5%
3/24 • 17 weeks
|
13.0%
3/23 • 17 weeks
|
20.0%
4/20 • 17 weeks
|
0.00%
0/23 • 17 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.2%
1/24 • 17 weeks
|
0.00%
0/23 • 17 weeks
|
10.0%
2/20 • 17 weeks
|
0.00%
0/23 • 17 weeks
|
|
Nervous system disorders
Headache
|
4.2%
1/24 • 17 weeks
|
8.7%
2/23 • 17 weeks
|
5.0%
1/20 • 17 weeks
|
0.00%
0/23 • 17 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Low oxygen saturation
|
0.00%
0/24 • 17 weeks
|
4.3%
1/23 • 17 weeks
|
10.0%
2/20 • 17 weeks
|
0.00%
0/23 • 17 weeks
|
|
General disorders
General fatigue
|
8.3%
2/24 • 17 weeks
|
21.7%
5/23 • 17 weeks
|
25.0%
5/20 • 17 weeks
|
4.3%
1/23 • 17 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.3%
2/24 • 17 weeks
|
21.7%
5/23 • 17 weeks
|
20.0%
4/20 • 17 weeks
|
0.00%
0/23 • 17 weeks
|
|
Musculoskeletal and connective tissue disorders
Lower extremity fatigue
|
8.3%
2/24 • 17 weeks
|
0.00%
0/23 • 17 weeks
|
20.0%
4/20 • 17 weeks
|
0.00%
0/23 • 17 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle Soreness
|
0.00%
0/24 • 17 weeks
|
17.4%
4/23 • 17 weeks
|
20.0%
4/20 • 17 weeks
|
0.00%
0/23 • 17 weeks
|
|
Immune system disorders
Sick
|
4.2%
1/24 • 17 weeks
|
21.7%
5/23 • 17 weeks
|
25.0%
5/20 • 17 weeks
|
0.00%
0/23 • 17 weeks
|
Additional Information
Dr. Lee Jones, PhD
Memorial Sloan Kettering Cancer Center
Phone: 646-888-8103
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place