Home-Based Respiratory Muscle Training and Aerobic Exercise Programs to Improve Lung Health in Cu… (NCT07553819) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Home-Based Respiratory Muscle Training and Aerobic Exercise Programs to Improve Lung Health in Current and Former Cigarette Smokers
United States200 participantsStarted 2026-08-01
Plain-language 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.
Who can participate
Age range
50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Compliance rate (Feasibility)
Timeframe: Up to 12 weeks
2
Adherence rate (Feasibility)
Timeframe: Up to 12 weeks
3
Assessing inspiratory and expiratory muscle strength
Timeframe: At baseline, 6 weeks, and 12 weeks
4
change in St. George Respiratory Questionnaire (SGRQ)