What this study is
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.
What's being tested
- Accelerometry
Intervention · PROCEDURE
- Aerobic Exercise
Intervention · OTHER
Complete tailored intensity AE cycling sessions
- Biospecimen Collection
Intervention · PROCEDURE
Undergo blood, nasal swab, exhaled breath, and urine sample collection
- Educational Intervention
Intervention · OTHER
Receive AE and RMT education
- Electronic Health Record Review
Intervention · OTHER
- Physical Performance Testing
Intervention · OTHER
- Respiratory Muscle Training
Intervention · PROCEDURE
Complete RMT sessions
- Supportive Care
Intervention · OTHER
Receive virtually supervised session/call
- Survey Administration
Intervention · OTHER
All of Accelerometry, Electronic Health Record Review, Physical Performance Testing, Survey Administration
Ancillary studies
Study details
- Official title
- Effects of Respiratory Muscle Training and Aerobic Exercise on Lung Health in Smokers: A Pilot Parallel-Group Study for Lung Cancer Prevention
- Sponsor
- Roswell Park Cancer Institute
- Conditions
- Lung Carcinoma
- Enrolling
- 200 people
- Starts
- 2026-12-15
- Est. completion
- 2029-05-01
- Design
- Open-label, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 50 Years and overSex ALLHealthy volunteers AcceptedYou 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 can't join 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openRoswell Park Cancer Institute
Buffalo, New York, United States
- Andrew D. Ray · Contact716-845-2381Andrew.Ray@RoswellPark.org
- Andrew D. Ray · Principal investigator
Study team
Sponsor
Roswell Park Cancer Institute
Study ID I-4565025
Principal investigator
Andrew D Ray
Roswell Park Cancer Institute
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.