Preoperative Respiratory Muscle Training to Prevent Postoperative Pulmonary Complications in Patients Undergoing Resection for Lung Cancer
Summary
This phase II trial studies how well respiratory muscle training before surgery works in preventing lung complications after surgery in patients with stage I-IIIB lung cancer. Patients with lung cancer who choose to undergo surgical resection often have complications after surgery such as pneumonia, unplanned intubations, difficulty breathing and reduced physical functioning, and increased medical costs and a reduced quality of life. Improving pre-surgical pulmonary health through respiratory muscle training may improve respiratory muscle strength, response to surgery, and quality of life after surgery in patients with lung cancer.
Detailed description
PRIMARY OBJECTIVES: I. Assess the impact of a short-duration respiratory muscle training (RMT) program on respiratory muscle strength in patients undergoing resection for lung cancer. SECONDARY OBJECTIVES: I. Compare the extent of diaphragm atrophy and catabolic/anabolic pathway activation between RMT responders and non-responders evaluated for gene expression and candidate and candidate causative protein levels. II. Determine the effect of the short-duration RMT program on health related quality-of-life measures. III. Assess the impact of the short-duration RMT program on postoperative outcomes. EXPLORATORY OBJECTIVES: I. Determine the financial sustainability of a transitional home-based prehabilitation program targeting respiratory muscle weakness prior to lung resection. II. Analysis of molecular markers to correlate with patient outcome and potentially differentiate responders from non-responders. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I (USUAL CARE): Patients receive usual care consisting of physical therapy once weekly, receiving pre-surgical information, instruction on the use of a spirometer device, and wearing a Fitbit to track activity. Patients then undergo video-assisted thoracic surgery or laparoscopic surgery. Patients continue to track activity using the Fitbit for 3 months post-surgery. ARM II (RMT + USUAL CARE): Patients use a power lung device to complete 3 sets of 15 RMT exercises over 30 minutes 6 days per week over 2-4 weeks for a minimum of 12 sessions prior to surgery. Patients also receive usual care consisting of physical therapy once weekly, receiving pre-surgical information, instruction on the use of a spirometer device, and wearing a Fitbit to track activity. Patients then undergo video-assisted thoracic surgery or laparoscopic surgery. Patients continue to track activity using the Fitbit for 3 months post-surgery. After completion of study, patients are followed up at 1, 3, 6, and 12 months.
Arms & interventions
- OtherBest Practice
Receive usual care
- ProcedureLaparoscopic Surgery
Undergo laparoscopic surgery
- OtherQuality-of-Life Assessment
Ancillary studies
- OtherQuestionnaire Administration
Ancillary studies
- DeviceRespiratory Muscle Training Device
Use power lung device to complete RMT
- ProcedureVideo-Assisted Thoracic Surgery
Undergo video-assisted thoracic surgery
Outcome measures
Primary
Change in inspiratory and expiratory muscle strength
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.
Time frame: Baseline up to 12 months
Change in pulmonary function and respiratory muscle endurance
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.
Time frame: Baseline up to 12 months
Change in peak exercise capacity (VO2peak)
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.
Time frame: Baseline up to 12 months
Secondary
Metabolic and muscle physiology marker analysis
Time frame: At time of surgical resection
Gene expression ribonucleic acid (RNA) extraction, reverse transcription, and real-time quantitative polymerase chain reaction (PCR) analysis
Time frame: At time of surgical resection
Change in quality of life (QoL)
Time frame: Baseline up to 12 months
Change in QoL
Time frame: Baseline up to 12 months
Change in fatigue level
Time frame: Baseline up to 12 months
Change in sleepiness (sleep apnea)
Time frame: Baseline up to 12 months
Change in sleepiness (sleep apnea)
Time frame: Baseline up to 12 months
Change in sleep quality
Time frame: Baseline up to 12 months
Change in anxiety and depression
Time frame: Baseline up to 12 months
Change in dyspnea
Time frame: Baseline up to 12 months
Presence or absence of pneumonia diagnoses
Time frame: Up to 12 months
Eligibility criteria
Study locations (1)
Roswell Park Cancer Institute
Buffalo, New York, 14263