Home-Based Respiratory Muscle Training and Aerobic Exercise Programs to Improve Lung Health in Current and Former Cigarette Smokers

August 20, 2026 updated by: Roswell Park Cancer Institute

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Buffalo, New York, United States, 14263
        • Roswell Park Cancer Institute
        • Contact:
        • Principal Investigator:
          • Andrew D. Ray

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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
  • Cognitively capable of following direction and performing the intervention
  • Understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure

Exclusion Criteria:

  • 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
  • Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study intervention

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort A Arm I (RMT)
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.
Other: Survey Administration
Ancillary studies
Other: Electronic Health Record Review
Ancillary studies
Other: Physical Performance Testing
Ancillary studies
Other Names:
  • Physical Fitness Testing
  • Physical Function Testing
Procedure: Accelerometry
Ancillary studies
Procedure: Biospecimen Collection
Undergo blood, nasal swab, exhaled breath, and urine sample collection
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection
Procedure: Respiratory Muscle Training
Complete RMT sessions
Other Names:
  • RMT
Other: Supportive Care
Receive virtually supervised session/call
Other Names:
  • Supportive Therapy
  • Symptom Management
  • Therapy, Supportive
Experimental: Cohort A Arm II (AE)
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.
Other: Survey Administration
Ancillary studies
Other: Electronic Health Record Review
Ancillary studies
Other: Physical Performance Testing
Ancillary studies
Other Names:
  • Physical Fitness Testing
  • Physical Function Testing
Procedure: Accelerometry
Ancillary studies
Procedure: Biospecimen Collection
Undergo blood, nasal swab, exhaled breath, and urine sample collection
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection
Other: Supportive Care
Receive virtually supervised session/call
Other Names:
  • Supportive Therapy
  • Symptom Management
  • Therapy, Supportive
Other: Aerobic Exercise
Complete tailored intensity AE cycling sessions
Other Names:
  • Aerobic Activity
Active Comparator: Cohort A Arm III (AE and RMT education)
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.
Other: Survey Administration
Ancillary studies
Other: Electronic Health Record Review
Ancillary studies
Other: Physical Performance Testing
Ancillary studies
Other Names:
  • Physical Fitness Testing
  • Physical Function Testing
Procedure: Accelerometry
Ancillary studies
Procedure: Biospecimen Collection
Undergo blood, nasal swab, exhaled breath, and urine sample collection
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection
Other: Educational Intervention
Receive AE and RMT education
Other Names:
  • Education for Intervention
  • Intervention by Education
  • Intervention through Education
  • Intervention, Educational
Experimental: Cohort B Arm IV (RMT)
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.
Other: Survey Administration
Ancillary studies
Other: Physical Performance Testing
Ancillary studies
Other Names:
  • Physical Fitness Testing
  • Physical Function Testing
Procedure: Accelerometry
Ancillary studies
Procedure: Biospecimen Collection
Undergo blood, nasal swab, exhaled breath, and urine sample collection
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection
Procedure: Respiratory Muscle Training
Complete RMT sessions
Other Names:
  • RMT
Other: Supportive Care
Receive virtually supervised session/call
Other Names:
  • Supportive Therapy
  • Symptom Management
  • Therapy, Supportive
Active Comparator: Cohort B Arm V (AE and RMT education)
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.
Other: Survey Administration
Ancillary studies
Other: Physical Performance Testing
Ancillary studies
Other Names:
  • Physical Fitness Testing
  • Physical Function Testing
Procedure: Accelerometry
Ancillary studies
Procedure: Biospecimen Collection
Undergo blood, nasal swab, exhaled breath, and urine sample collection
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection
Other: Educational Intervention
Receive AE and RMT education
Other Names:
  • Education for Intervention
  • Intervention by Education
  • Intervention through Education
  • Intervention, Educational

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compliance rate (Feasibility)
Time Frame: Up to 12 weeks
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.
Up to 12 weeks
Adherence rate (Feasibility)
Time Frame: Up to 12 weeks
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.
Up to 12 weeks
Assessing inspiratory and expiratory muscle strength
Time Frame: At baseline, 6 weeks, and 12 weeks
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
At baseline, 6 weeks, and 12 weeks
change in St. George Respiratory Questionnaire (SGRQ)
Time Frame: At baseline, 6 weeks, and 12 weeks
The SGRQ comprises of 50 items and consists of two parts. Scores range from 0-100, with higher scores indicating worse quality of life.
At baseline, 6 weeks, and 12 weeks
Functional capacity
Time Frame: At baseline, 6 weeks, and 12 weeks
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.
At baseline, 6 weeks, and 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lower extremity strength
Time Frame: At baseline and 12 weeks
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.
At baseline and 12 weeks
Physical performance
Time Frame: At baseline and 12 weeks
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.
At baseline and 12 weeks
Physical activity levels
Time Frame: Up to 12 weeks
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.
Up to 12 weeks
Patient-reported outcomes on Fatigue
Time Frame: At baseline and 12 weeks
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
At baseline and 12 weeks
High-sensitivity C-reactive protein
Time Frame: At baseline and 12 weeks
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.
At baseline and 12 weeks
Cardiac biomarkers
Time Frame: At baseline and at 12 weeks
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.
At baseline and at 12 weeks
Dyspnea patient reported response
Time Frame: Baseline and at 12 weeks
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
Baseline and at 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Roswell Park Cancer Institute

Investigators

  • Principal Investigator: Andrew D Ray, Roswell Park Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 15, 2026

Primary Completion (Estimated)

May 1, 2029

Study Completion (Estimated)

May 1, 2029

Study Registration Dates

First Submitted

April 1, 2026

First Submitted That Met QC Criteria

April 20, 2026

First Posted (Actual)

April 28, 2026

Study Record Updates

Last Update Posted (Actual)

August 21, 2026

Last Update Submitted That Met QC Criteria

August 20, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • I-4565025 (Other Identifier: Roswell Park Cancer Institute)
  • NCI-2026-01887 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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