An interventional study of Accelerometry and Aerobic Exercise in Lung Carcinoma, sponsored by Roswell Park Cancer Institute. Not yet recruiting at 1 site in United States. Open to participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-21.
Sponsored by Roswell Park Cancer Institute · Not applicable, Interventional, and 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.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's planned enrollment of 200 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
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Of its 38 completed or terminated interventional studies of FDA-regulated products, 21 (55%) have results posted.
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Exclusion Criteria:
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 QW to provide support, enhance safety, and promote training compliance on study. Additionally, patients undergo blood, nasal swab, exhaled breath, and urine sample collection on study.
Procedure: Accelerometry · Procedure: Biospecimen Collection · Other: Electronic Health Record Review · Other: Physical Performance Testing · Procedure: Respiratory Muscle Training · Other: Supportive Care · Other: Survey Administration
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. Additionally, patients undergo blood, nasal swab, exhaled breath, and urine sample collection on study.
Procedure: Accelerometry · Other: Aerobic Exercise · Procedure: Biospecimen Collection · Other: Electronic Health Record Review · Other: Physical Performance Testing · Other: Supportive Care · Other: Survey Administration
Participants receive education on AE and RMT including recommendations aligned with current guidelines 5 days a week for 12 weeks. Additionally, patients undergo blood, nasal swab, exhaled breath, and urine sample collection on study.
Procedure: Accelerometry · Procedure: Biospecimen Collection · Other: Educational Intervention · Other: Electronic Health Record Review · Other: Physical Performance Testing · Other: Survey Administration
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. Additionally, patients undergo blood, nasal swab, exhaled breath, and urine sample collection on study.
Procedure: Accelerometry · Procedure: Biospecimen Collection · Other: Physical Performance Testing · Procedure: Respiratory Muscle Training · Other: Supportive Care · Other: Survey Administration
Participants receive education on AE and RMT as in arm III on study. Additionally, patients undergo blood, nasal swab, exhaled breath, and urine sample collection on study.
Procedure: Accelerometry · Procedure: Biospecimen Collection · Other: Educational Intervention · Other: Physical Performance Testing · Other: Survey Administration
Ancillary studies
Complete tailored intensity AE cycling sessions
Also known as: Aerobic Activity
Undergo blood, nasal swab, exhaled breath, and urine sample collection
Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection
Receive AE and RMT education
Also known as: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Ancillary studies
Ancillary studies
Also known as: Physical Fitness Testing, Physical Function Testing
Complete RMT sessions
Also known as: RMT
Receive virtually supervised session/call
Also known as: Supportive Therapy, Symptom Management, Therapy, Supportive
Ancillary 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.
Time frame: Up to 12 weeks
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.
Time frame: Up to 12 weeks
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
Time frame: At baseline, 6 weeks, and 12 weeks
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.
Time frame: At baseline, 6 weeks, and 12 weeks
Functional capacity
Measured by the 6-Minute Walk Test. Will be summarized at pre-, 6-week and post-intervention timepoints, regardless of treatment regimen, using the appropriate descriptive statistics and graphically summarized. 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. Comparisons at the 6-week and 3-month follow-up visits will be secondary and will only be performed if the primary comparison for the corresponding endpoint reaches statistical significance. For cohort A, Bonferroni's correction will be applied to adjust for three pairwise comparisons.
Time frame: At baseline, 6 weeks, and 12 weeks
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.
Time frame: At baseline and 12 weeks
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.
Time frame: At baseline and 12 weeks
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.
Time frame: Up to 12 weeks
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
Time frame: At baseline and 12 weeks
High-sensitivity C-reactive protein
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.
Time frame: At baseline and 12 weeks
Cardiac biomarkers
Will assess cardiac biomarkers, such as high-sensitivity troponin T and N-terminal pro-brain natriuretic peptide. 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. Biomarker data will be appropriately transformed prior to analysis to meet model assumptions.
Time frame: At baseline and at 12 weeks
Dyspnea patient reported response
he Dyspnea-12 describes the different qualitative dimensions of breathlessness. Each 12- item (seven for the physical and five for the affective components) score ranges from 'none' (score 0) to 'severe' (score 3) with a total score ranging from 0 to 36 (lower is better), a physical score ranging from 0 to 21 and an affective score ranging from 0 to 15
Time frame: Baseline and at 12 weeks
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Roswell Park Cancer Institute