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

NCT07553819 | Not Yet Recruiting

• 2 other identifiers: I-4565025NCI-2026-01887
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lung Carcinoma

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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

  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.

  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.

  At baseline, 6 weeks, and 12 weeks

Secondary Outcomes (7)

• Lower extremity strength

  At baseline and 12 weeks

• Physical performance

  At baseline and 12 weeks

• Physical activity levels

  Up to 12 weeks

• Patient-reported outcomes on Fatigue

  At baseline and 12 weeks

• High-sensitivity C-reactive protein

  At baseline and 12 weeks

Study Arms (5)

Cohort A Arm I (RMT)

EXPERIMENTAL

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

Cohort A Arm II (AE)

EXPERIMENTAL

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

Cohort A Arm III (AE and RMT education)

ACTIVE COMPARATOR

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

Cohort B Arm IV (RMT)

EXPERIMENTAL

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

Cohort B Arm V (AE and RMT education)

ACTIVE COMPARATOR

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

Interventions

Accelerometry PROCEDURE

Ancillary studies

Cohort A Arm I (RMT); Cohort A Arm II (AE); Cohort A Arm III (AE and RMT education); Cohort B Arm IV (RMT); Cohort B Arm V (AE and RMT education)

Aerobic Exercise OTHER

Complete tailored intensity AE cycling sessions

Also known as: Aerobic Activity

Cohort A Arm II (AE)

Biospecimen Collection PROCEDURE

Undergo blood, nasal swab, exhaled breath, and urine sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Cohort A Arm I (RMT); Cohort A Arm II (AE); Cohort A Arm III (AE and RMT education); Cohort B Arm IV (RMT); Cohort B Arm V (AE and RMT education)

Educational Intervention OTHER

Receive AE and RMT education

Also known as: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

Cohort A Arm III (AE and RMT education); Cohort B Arm V (AE and RMT education)

Electronic Health Record Review OTHER

Ancillary studies

Cohort A Arm I (RMT); Cohort A Arm II (AE); Cohort A Arm III (AE and RMT education)

Physical Performance Testing OTHER

Ancillary studies

Also known as: Physical Fitness Testing, Physical Function Testing

Cohort A Arm I (RMT); Cohort A Arm II (AE); Cohort A Arm III (AE and RMT education); Cohort B Arm IV (RMT); Cohort B Arm V (AE and RMT education)

Respiratory Muscle Training PROCEDURE

Complete RMT sessions

Also known as: RMT

Cohort A Arm I (RMT); Cohort B Arm IV (RMT)

Supportive Care OTHER

Receive virtually supervised session/call

Also known as: Supportive Therapy, Symptom Management, Therapy, Supportive

Cohort A Arm I (RMT); Cohort A Arm II (AE); Cohort B Arm IV (RMT)

Survey Administration OTHER

Ancillary studies

Cohort A Arm I (RMT); Cohort A Arm II (AE); Cohort A Arm III (AE and RMT education); Cohort B Arm IV (RMT); Cohort B Arm V (AE and RMT education)

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Accelerometry; Exercise; Specimen Handling; Early Intervention, Educational; Educational Status; Methods; Exercise Test; Breathing Exercises; Palliative Care

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Socioeconomic Factors; Population Characteristics; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities; Patient Care

Study Officials

• Andrew D Ray

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2026
• First Posted: April 28, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): May 1, 2029
• Last Updated: April 28, 2026

Record last verified: 2026-04

Locations

US (1)