Respiratory Muscle Training Before Lung Cancer Surgery
This study is looking at whether respiratory muscle training (RMT) before surgery can help prevent lung problems after surgery for people with stage I-IIIB lung cancer. Patients with lung cancer who have surgery sometimes experience complications like pneumonia or difficulty breathing. This study wants to see if using a special device for RMT, called a Power Lung device, can make your breathing muscles stronger before surgery. This might help you recover better and improve your quality of life after surgery. The study will measure changes in your breathing muscle strength, lung function, and how well you can exercise over 12 months. You may be able to join if you have stage I-IIIB lung cancer and are having surgery for it, and can speak and read English.
- Study design
- This study involves 220 participants and compares two groups: one receiving usual care and another receiving respiratory muscle training. Participants are randomly assigned to one of these groups.
- What's involved
- Participants will either receive usual care or use a Power Lung device for respiratory muscle training before surgery. All participants will undergo surgery and track activity with a Fitbit for 3 months post-surgery.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will follow participants for up to 12 months after they begin the study to measure changes in muscle strength, lung function, and exercise capacity.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Respiratory Muscle Training Before Surgery in Preventing Lung Complications in Patients With Stage I-IIIB Lung Cancer
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Ellis Levine, MD · 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
- Change in inspiratory and expiratory muscle strengthBaseline up to 12 months
Will be treated as a continuous variable and will be summarized by treatment group and time-point using the mean, median, standard deviation, and the appropriate percentiles. The effectiveness of the respiratory muscle training (RMT) program on each respiratory outcome will be assessed by comparing the preoperative change between groups using an analysis of covariance (ANCOVA) model, with an adjustment for the pretreatment levels. For each outcome, the preoperative change (T1-T0) will be modeled as a function of treatment group (RMT versus usual care) and pre-treatment levels. A one-sided Wald type-test about coefficient for treatment group will evaluate whether the RMT program had a beneficial impact on the given respiratory outcome. All model assumptions will be verified graphically using quantile-quantile and residual plots. Transformations will be applied as appropriate.
- Change in pulmonary function and respiratory muscle enduranceBaseline up to 12 months
Will be treated as a continuous variable and will be summarized by treatment group and time-point using the mean, median, standard deviation, and the appropriate percentiles. The effectiveness of the RMT program on each respiratory outcome will be assessed by comparing the preoperative change between groups using an ANCOVA model, with an adjustment for the pretreatment levels. For each outcome, the preoperative change (T1-T0) will be modeled as a function of treatment group (RMT versus usual care) and pre-treatment levels. A one-sided Wald type-test about coefficient for treatment group will evaluate whether the RMT program had a beneficial impact on the given respiratory outcome. All model assumptions will be verified graphically using quantile-quantile and residual plots. Transformations will be applied as appropriate.
- Change in peak exercise capacity (VO2peak)Baseline up to 12 months
Will be treated as a continuous variable and will be summarized by treatment group and time-point using the mean, median, standard deviation, and the appropriate percentiles. The effectiveness of the RMT program on each respiratory outcome will be assessed by comparing the preoperative change between groups using an ANCOVA model, with an adjustment for the pretreatment levels. For each outcome, the preoperative change (T1-T0) will be modeled as a function of treatment group (RMT versus usual care) and pre-treatment levels. A one-sided Wald type-test about coefficient for treatment group will evaluate whether the RMT program had a beneficial impact on the given respiratory outcome. All model assumptions will be verified graphically using quantile-quantile and residual plots. Transformations will be applied as appropriate.