Home-Based Exercise Programs for Lung Health in Smokers
This study is looking at whether home-based respiratory muscle training (RMT) and aerobic exercise (AE) can improve lung health in current and former cigarette smokers. RMT involves using a handheld device for breathing exercises against resistance, and AE involves cycling sessions. The study aims to see if these programs are practical to deliver at home, how they affect your quality of life, fatigue, and breathing, and if they can improve markers in your blood and breath related to lung injury or inflammation. You might be eligible if you are 50 or older, a current smoker with a 20+ pack-year history, or a former smoker within the last 15 years with a 20+ pack-year history, and can understand English.
- Study design
- This interventional study plans to enroll 200 participants. Participants will be assigned to different groups, some receiving RMT, some AE, and some a combination, over 12 weeks.
- What's involved
- You would participate in RMT or AE sessions 5 days a week for 12 weeks, with weekly virtual support. You will also have blood, nasal swab, exhaled breath, and urine sample collections, and assessments of your muscle strength at the beginning, 6 weeks, and 12 weeks.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your compliance and adherence to the programs will be measured for up to 12 weeks, and muscle strength will be assessed at baseline, 6 weeks, and 12 weeks.
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Home-Based Respiratory Muscle Training and Aerobic Exercise Programs to Improve Lung Health in Current and Former Cigarette Smokers
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Andrew D Ray · PRINCIPAL_INVESTIGATOR · Roswell Park Cancer Institute
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Compliance rate (Feasibility)Up to 12 weeks
The primary objective is in the feasibility of conducting the respiratory muscle training (RMT) and aerobic exercise (AE) intervention relative to the sham control. In the RMT group, overall compliance (e.g., compliant at all time points) will be estimated using 90% confidence intervals (CIs) obtained Clopper-Pearson method. The lower bounds will define a plausible lower limit for true (unobserved) compliance rates. Additionally, compliance status will be modeled as a function of time (e.g., week), and pre-specified exogenous factors using a generalized estimating equation logistic regression model (autoregressive covariance structure). Estimates of compliance rates will be obtained by time-point and tests about the appropriate contrasts of model estimates will be used to determine if there is a time trend.
- Adherence rate (Feasibility)Up to 12 weeks
The primary objective is in the feasibility of conducting the RMT and AE intervention relative to the sham control. In the RMT group, overall adherence (complete ≥ 70% of sessions) rates will be estimated using 90% CIs obtained Clopper-Pearson method. The lower bounds will define a plausible lower limit for true (unobserved) adherence rates.
- Assessing inspiratory and expiratory muscle strengthAt baseline, 6 weeks, and 12 weeks
Participants will complete 3 sets of 15 breaths, 5 days/week using commercially available Power Lung. resistance will be increased 5-10% every week . Participants will rate and log their effort
- change in St. George Respiratory Questionnaire (SGRQ)At baseline, 6 weeks, and 12 weeks
The SGRQ comprises of 50 items and consists of two parts. Scores range from 0-100, with higher scores indicating worse quality of life.
- Functional capacityAt baseline, 6 weeks, and 12 weeks
Measured by the 6-Minute Walk Test. Will be summarized at pre-, 6-week and post-intervention timepoints, regardless of treatment regimen, using the appropriate descriptive statistics and graphically summarized. The outcome will be analyzed using a linear mixed model, with the intervention arms and time points as predictors. Baseline measurements will be included as a covariate to adjust for initial differences. Both within-and between-group comparisons will be conducted using appropriate contrasts. The primary comparisons will focus on between-arm differences at the 12-week post-intervention time point. Comparisons at the 6-week and 3-month follow-up visits will be secondary and will only be performed if the primary comparison for the corresponding endpoint reaches statistical significance. For cohort A, Bonferroni's correction will be applied to adjust for three pairwise comparisons.