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The purpose of this study is to examine how a multimodality (having or using a variety of methods to do something) exercise intervention may improve survival, function, and quality of life in participants with advanced lung cancer.
This study is a randomized control trial at a single institution comparing advanced lung cancer patients undergoing supervised home-based exercise program versus usual care. The intervention is a supervised home-based exercise program that will be coordinated by the MOVE program. The regimen will be 12 weeks in duration, three times a week, and administered by a trained professional virtually.
Participants will be randomized 1:1 to the exercise or usual care arm. Participants will be stratified on baseline frailty by the SPPB.
Primary Objective To compare changes patient-reported fatigue (by FACT-F survey) from baseline to post-intervention in patients with locally advanced and advanced lung cancer receiving maintenance immunotherapy undergoing a supervised home-based exercise program versus usual care.
Secondary Objectives
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise Intervention | Experimental | Eligible and consented participants randomized to the exercise arm will work with an exercise trainer three times weekly for 12 weeks. Training sessions will be delivered virtually using HIPPA Complaint IU Health Zoom. These sessions will last 60 minutes and include cardiovascular exercise, resistance training, and balance or stretching exercise. The participants will be able to use any equipment they already have at home but will be provided a heart monitor and a set of resistance bands. All sessions will have a moderate-intensity training goal, defined as 40-80% of heart rate reserve (HRR). Cardiovascular exercise will include any at-home equipment available to the participants or follow a Tabata-style program. Resistance training will include a full body workout, emphasizing all major muscle groups. Trainers will progress or regress intensity levels based on the participant's rate of perceived exertion (RPE), heart rate, and individual response during each session. |
|
| Usual Care | No Intervention | Participants randomized to usual care arm will receive care per their treatment team. Usual care participants are encouraged to exercise but will not be provided components of the intervention. Participants in the usual care arm will be given usual care handouts at baseline. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise Intervention | Behavioral | Eligible and consented participants randomized to the exercise arm will work with an exercise trainer three times weekly for 12 weeks. Training sessions will be delivered virtually using HIPPA Complaint IU Health Zoom. These sessions will last 60 minutes and include cardiovascular exercise, resistance training, and balance or stretching exercise. The participants will be able to use any equipment they already have at home but will be provided a heart monitor and a set of resistance bands. All sessions will have a moderate-intensity training goal, defined as 40-80% of heart rate reserve (HRR). Cardiovascular exercise will include any at-home equipment available to the participants or follow a Tabata-style program. Resistance training will include a full body workout, emphasizing all major muscle groups. Trainers will progress or regress intensity levels based on the participant's rate of perceived exertion (RPE), heart rate, and individual response during each session. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in patient-reported fatigue | Measured by Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) survey | baseline, week 12, and week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in cardiorespiratory fitness | Measured by VO2peak, estimated as time on the treadmill | baseline, week 12, and week 24 |
| Change in physical performance battery | total score on short physical performance battery |
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Inclusion Criteria:
Age ≥ 18 years
Known diagnosis of locally advanced (stage III) or metastatic NSCLC
Patient is currently receiving maintenance immunotherapy for at least 1 month and planned for at least 3 additional months of therapy
Patient is willing and able to participate in a supervised home-based exercise program as determined by the MOVE program
a.Participants must have internet access and equipment to participate in virtual exercise
ECOG performance status of 0-2
Exclusion Criteria:
Already meeting exercise guidelines and participating in at least 150 minutes of moderate or vigorous exercise per IPAQ
Unable to participate in the supervised home-based exercise program as determined by the MOVE program
Medical co-morbidities that preclude patient from participating in supervised exercise, including but not limited to:
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| Name | Affiliation | Role |
|---|---|---|
| Tarah J Ballinger, MD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University Health Methodist Hospital | Indianapolis | Indiana | 46202 | United States | ||
| Indiana University Melvin & Bren Simon Comprehensive Cancer Center |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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|
| baseline, week 12, and week 24 |
| Change in muscle mass | measured by mg/kg2 on HU on CT scans | baseline, and week 12 |
| Change in muscle density | measured by mg/kg2 on HU on CT scans | baseline, and week 12 |
| Change in depression | measured by total score of HADS survey | baseline, week 12, and week 24 |
| Proportion of patients who are "fatigued" | measured by FACT-F score of <43 | baseline, week 12, and week 24 |
| Uptake of the study | the proportion of total patients approached, screened, and ultimately completing the baseline assessments | date open to accrual until closed to accrual, up to 5 years |
| Adherence with the intervention defined | the proportion of scheduled sessions attended by participants randomized to the exercise intervention arm | baseline to post 12-week intervention |
| Indianapolis |
| Indiana |
| 46202 |
| United States |
| Sidney and Lois Eskenazi Hospital | Indianapolis | Indiana | 46202 | United States |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D001519 | Behavior |