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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Duke University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| Progressive Stretching Group (Attention-Control) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aerobic Training | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in VO2peak (on Exercise Capacity) | To compare the efficacy of different types of exercise training modalities, relative to progressive stretching (attention control group) | 17 weeks |
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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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Lee Jones, PhD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39606939 | Derived | 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. | |
| 34658160 | Derived |
| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | Posted | Mean | Standard Deviation | mL/kg/min | 17 weeks |
|
17 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abnormal heart rate response | Cardiac disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Lee Jones, PhD | Memorial Sloan Kettering Cancer Center | 646-888-8103 | jonesl3@mskcc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 31, 2017 | Mar 12, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D055070 | Resistance Training |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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| 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. |
|
|
| Progressive Stretching | Behavioral | 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 Training | Behavioral | 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 Training | Behavioral | 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. |
|
| Scott 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. |
| Second cancer |
|
| Disease progression |
|
| BG001 | 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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. |
| OG002 | 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. |
| OG003 | 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. |
|
|
| 0 |
| 24 |
| 0 |
| 24 |
| 8 |
| 24 |
| EG001 | 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. 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. | 0 | 23 | 0 | 23 | 15 | 23 |
| EG002 | 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. 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. | 0 | 20 | 0 | 20 | 12 | 20 |
| EG003 | 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. | 0 | 23 | 0 | 23 | 3 | 23 |
| Abnormal blood pressure response | Vascular disorders | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Electrocardiogram abnormalities | Cardiac disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Low oxygen saturation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| General fatigue | General disorders | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Lower extremity fatigue | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Muscle Soreness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Sick | Immune system disorders | Systematic Assessment |
|
Not provided
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| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |