Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Carcinoma | Lung Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (9)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Accelerometry | Procedure | — | UNRESOLVED |
| Aerobic Exercise | Other | — | UNRESOLVED |
| Biospecimen Collection | Procedure | — | UNRESOLVED |
| Educational Intervention | Other | — | UNRESOLVED |
| Electronic Health Record Review | Other | — | UNRESOLVED |
| Physical Performance Testing | Other | — | UNRESOLVED |
| Respiratory Muscle Training | Procedure | — | UNRESOLVED |
| Supportive Care | Other | — | UNRESOLVED |
| Survey Administration |
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- Cohort A Arm I (RMT)
- description
- 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.
- interventionNames
- Procedure: Accelerometry
- Procedure: Biospecimen Collection
- Other: Electronic Health Record Review
- Other: Physical Performance Testing
- Procedure: Respiratory Muscle Training
- Other: Supportive Care
- Other: Survey Administration
- type
- EXPERIMENTAL
- label
- Cohort A Arm II (AE)
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available