Effects of Respiratory Muscle Training and Aerobic Exercise on Lung Health in Smokers: A Pilot Parallel-Group Study for Lung Cancer Prevention
Effects of Respiratory Muscle Training and Aerobic Exercise on Lung Health in Smokers: A Pilot Parallel-Group Study for Lung Cancer Prevention
This clinical trial studies whether home-based respiratory muscle training (RMT) and aerobic exercise (AE) programs can be used to improve lung health in current and former cigarette smokers. Lung cancer, the leading cause of cancer death, is overwhelmingly caused by exposure to cigarette smoke. Research suggests that daily activity reduces lung cancer risk in current and former smokers. However, current and former smokers are generally not active and new approaches to improve lung health are needed. During the home-based RMT program, participants use a handheld device to complete breathing exercise sessions consisting of breathing in and out against adjustable resistance. During the home-based AE program, participants complete aerobic exercises using a stationary bike working at a moderate workload against adjustable resistance. The home-based RMT and AE programs may be effective ways to strengthen the breathing muscles, which may improve lung health in current and former cigarette smokers.
PRIMARY OBJECTIVES:
I. Evaluate the feasibility of delivering a home-based AE and RMT program in individuals at high risk for lung cancer.
II. Assess the effects of AE and RMT on patient-reported outcomes (PROs), including QoL, fatigue, dyspnea, performance metrics such as respiratory muscle strength and lower extremity strength; the 6-minute walk test; and daily activity levels in high-risk individuals.
III. Investigate whether RMT and/or AE improve peripheral and exhaled biomarkers associated with lung injury, inflammation, and/or oxidative stress.
OUTLINE: Participants scheduled for a computed tomography (CT) scan are assigned to cohort A, participants who call the New York State Quitline (NYSQL) are assigned to cohort B.
COHORT A: Participants are randomized to 1 of 3 arms.
ARM I: Participants complete RMT sessions via the Power Lung device over 20-30 minutes each consisting of three sets of 15 breaths at a gradual increase in resistance, 5 days a week, for 12 weeks in the absence of unacceptable toxicity. Participants also receive a virtually supervised session/call once a week (QW) to provide support, enhance safety, and promote training compliance on study.
ARM II: Participants complete tailored intensity AE cycling sessions progressing to over 30 minutes each, 5 days a week, for 12 weeks in the absence of unacceptable toxicity. Participants also receive a virtually supervised session/call QW to provide support, enhance safety, and promote training compliance on study.
ARM III: Participants receive education on AE and RMT including recommendations aligned with current guidelines 5 days a week for 12 weeks.
COHORT B: Participants are randomized to 1 of 2 arms.
ARM IV: Participants complete RMT sessions as in arm I for 12 weeks in the absence of unacceptable toxicity. Participants also receive a virtually supervised session/call QW to provide support, enhance safety, and promote training compliance on study.
ARM V: Participants receive education on AE and RMT as in arm III on study.
Additionally, all patients undergo blood, nasal swab, exhaled breath, and urine sample collection on study.
After completion of study intervention, participants may be optionally followed up at week 24.
Inclusion Criteria:
Exclusion Criteria: