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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 1. To compare changes in cardiorespiratory fitness measured by VO2peak, estimated as time on the treadmill during ramp treadmill test, from baseline to post-intervention in patients with locally advanced/advanced lung cancer receiving maintenance immunotherapy undergoing a supervised home-based exercise program versus usual care. 2. To compare changes in physical function measured by the short physical performance battery from baseline to post-intervention in patients with locally advanced/advanced lung cancer receiving maintenance immunotherapy undergoing a supervised home-based exercise program versus usual care. 3. To compare changes in muscle mass and muscle density measured on CT scans for disease monitoring and bioimpedance analysis from baseline to post-intervention in patients with locally advanced/advanced lung cancer receiving maintenance immunotherapy undergoing a supervised home-based exercise program versus usual care. 4. To compare changes in depression scores by HADS survey from baseline to post-intervention in patients with locally advanced and/or advanced lung cancer receiving maintenance immunotherapy undergoing a supervised home-based exercise program versus usual care. 5. To compare the proportion of patients who are "fatigued," defined as a FACT-F score of \<43 at post-intervention between the exercise and usual care arms. 6. To evaluate uptake and adherence of supervised home-based exercise program in patients with locally advanced and/or advanced lung cancer receiving maintenance immunotherapy or targeted therapy, measured by the percentage of patients who consented to the study and percentage of training sessions attended by patients in the exercise arm.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Indiana University Health Methodist Hospital
Indianapolis, Indiana, United States
Indiana University Melvin & Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana, United States
Sidney and Lois Eskenazi Hospital
Indianapolis, Indiana, United States
Start Date
October 15, 2024
Primary Completion Date
December 1, 2029
Completion Date
December 1, 2029
Last Updated
May 1, 2025
100
ESTIMATED participants
Exercise Intervention
BEHAVIORAL
Lead Sponsor
Indiana University
NCT07336732
NCT07190248
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT05692635