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.
Age ≥ 50 years old
Current smoker with a ≥ 20-pack-years history
Former smoker within the past 15 years, with a history of ≥ 20 pack-years (CT scan cohort only)
Participant must be able to speak, read and comprehend English language
Any previous lung cancer diagnoses and or undergoing treatment for any cancer
Recent pneumonia, bronchitis, or other inflammatory conditions in the lungs, including but limited to chronic obstructive pulmonary disease (COPD) and/or asthma exacerbation within the previous 6 months
Have uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, heart failure or psychiatric illness/social situations that would limit compliance with study requirements
Unwilling or unable to follow protocol requirements
Parallel
Accelerometry
Procedure/SurgeryAncillary studies
Aerobic Exercise
Other interventionComplete tailored intensity AE cycling sessions
Biospecimen Collection
Procedure/SurgeryUndergo blood, nasal swab, exhaled breath, and urine sample collection
Educational Intervention
Other interventionReceive AE and RMT education
Electronic Health Record Review
Other interventionAncillary studies
Physical Performance Testing
Other interventionAncillary studies
Respiratory Muscle Training
Procedure/SurgeryComplete RMT sessions
Supportive Care
Other interventionReceive virtually supervised session/call
Survey Administration
Other interventionAncillary studies
Compliance rate (Feasibility)
The primary objective is in the feasibility of conducting the respiratory muscle training (RMT) and aerobic exercise (AE) intervention relative to the sham control. In the RMT group, overall compliance (e.g., compliant at all time points) will be estimated using 90% confidence intervals (CIs) obtained Clopper-Pearson method. The lower bounds will define a plausible lower limit for true (unobserved) compliance rates. Additionally, compliance status will be modeled as a function of time (e.g., week), and pre-specified exogenous factors using a generalized estimating equation logistic regression model (autoregressive covariance structure). Estimates of compliance rates will be obtained by time-point and tests about the appropriate contrasts of model estimates will be used to determine if there is a time trend.
Adherence rate (Feasibility)
The primary objective is in the feasibility of conducting the RMT and AE intervention relative to the sham control. In the RMT group, overall adherence (complete ≥ 70% of sessions) rates will be estimated using 90% CIs obtained Clopper-Pearson method. The lower bounds will define a plausible lower limit for true (unobserved) adherence rates.
Assessing inspiratory and expiratory muscle strength
Participants will complete 3 sets of 15 breaths, 5 days/week using commercially available Power Lung. resistance will be increased 5-10% every week . Participants will rate and log their effort
change in St. George Respiratory Questionnaire (SGRQ)
The SGRQ comprises of 50 items and consists of two parts. Scores range from 0-100, with higher scores indicating worse quality of life.
Lower extremity strength
Measured using the 30-Second Sit-to-Stand Test. The outcome will be analyzed using a linear mixed model, with the intervention arms and time points as predictors. Baseline measurements will be included as a covariate to adjust for initial differences. Both within-and between-group comparisons will be conducted using appropriate contrasts. The primary comparisons will focus on between-arm differences at the 12-week post-intervention time point.
Physical performance
Measured using the Short Physical Performance Battery. The outcome will be analyzed using a linear mixed model, with the intervention arms and time points as predictors. Baseline measurements will be included as a covariate to adjust for initial differences. Both within-and between-group comparisons will be conducted using appropriate contrasts. The primary comparisons will focus on between-arm differences at the 12-week post-intervention time point.
Physical activity levels
daily step counts and minutes at various intensity levels will be monitored with an activity tracker. Both within-and between-group comparisons will be conducted using appropriate contrasts. The primary comparisons will focus on between-arm differences at the 12-week post-intervention time point.
Patient-reported outcomes on Fatigue
he Functional Assessment of Chronic Illness Therapy (FACIT- fatigue scale) is a 13-item patient-reported measure of fatigue. Items are scored on a 0 - 4 response scale with anchors ranging from "Not at all" to "Very much so". To score the FACIT-fatigue, all items are summed to create a single fatigue score with a range from 0 to 52. The higher the score, the lower the score the greater the fatigue severity
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