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

Part of paid clinical trials in Buffalo, New York.

Sponsor
Roswell Park Cancer Institute
Study ID
NCT07553819
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Accelerometry — PROCEDURE
    Ancillary studies
  • Aerobic Exercise — OTHER
    Complete tailored intensity AE cycling sessions
  • Biospecimen Collection — PROCEDURE
    Undergo blood, nasal swab, exhaled breath, and urine sample collection
  • Educational Intervention — OTHER
    Receive AE and RMT education
  • Electronic Health Record Review — OTHER
    Ancillary studies
  • Physical Performance Testing — OTHER
    Ancillary studies
  • Respiratory Muscle Training — PROCEDURE
    Complete RMT sessions
  • Supportive Care — OTHER
    Receive virtually supervised session/call
  • Survey Administration — OTHER
    Ancillary studies

Study Details

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.

Key Dates

Start date
May 1, 2026
Status verified
Apr 2026
Primary completion
May 1, 2029
Completion
May 1, 2029

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • 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.
  • 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.
  • 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.
  • 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.
  • 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.

Primary Outcome Measure

Compliance rate (Feasibility) [ Time Frame: Up to 12 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Roswell Park Cancer InstituteBuffaloNew York14263
Andrew D. Ray
[email protected]
716-845-2381
Andrew D. Ray (PRINCIPAL_INVESTIGATOR)

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By research site
Roswell Park Cancer Institute· Buffalo, NY

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