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

Effects of Respiratory Muscle Training and Aerobic Exercise on Lung Health in Smokers: A Pilot Parallel-Group Study for Lung Cancer Prevention

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
50 Years and older
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 12 weeks
  • Procedures mentioned: CT scans, Urine samples

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "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."
  • "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."
  • "ARM III: Participants receive education on AE and RMT including recommendations aligned with current guidelines 5 days a week for 12 weeks."
  • "ARM IV: Participants complete RMT sessions as in arm I for 12 weeks in the absence of unacceptable toxicity."
  • "Additionally, all patients undergo blood, nasal swab, exhaled breath, and urine sample collection on study."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official eligibility criteria

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 sites (1)

NY