Respiratory Strength Training in Cardiac Surgical Patients

Study Overview
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Brief Summary
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Swallowing difficulty (dysphagia) is a common postoperative complication in patients who undergo cardiac surgical procedures. Postoperative dysphagia in cardiac surgical patients is associated with negative health-related outcomes including increased rates of pneumonia, reintubation, and death as well as increased length of hospital stay and costs of care. This study will examine the safety, feasibility, and impact of preoperative respiratory strength training (RST) on swallowing and associated health-related outcomes in cardiac surgical patients. We hypothesize that preoperative RST will be safe, well-tolerated, and lead to improved swallowing and health-related outcomes in cardiac surgical patients.

Official Title
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Safety, Feasibility, and Impact of Preoperative Respiratory Strength Training in Cardiac Surgical Patients

Conditions
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Dysphagia, Cardiovascular Diseases, Thoracic Diseases, Surgery, Surgery--Complications

Intervention / Treatment
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* Device: Respiratory strength training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult 18-90 years old. Not pregnant. Undergoing planned cardiac surgery via sternotomy &/or extended thoracotomy & seen in the UF Health preoperative clinic. Confirmed COVID-19 negative test and/or no recent COVID-19 symptoms Has access to a computer, tablet, or electronic device with a stable internet connection for telehealth sessions. Willing to undergo testing procedures and complete the exercise training program Exclusion Criteria: Individuals under the age of 18 or over the age of 90. Pregnant women. Positive for COVID-19 or symptoms of COVID-19 No access to a computer, tablet, or electronic device &/ a stable internet connection for telehealth sessions. Unwilling to undergo testing procedures and/or complete the exercise training program.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: Longitudinal pilot cohort study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Respiratory strength training<br>Enrolled cardiac surgical patients will undergo 4 weeks of preoperative respiratory strength training using two respiratory strength training devices. | Device: Respiratory strength training<br>* Devices will be set to 70% of participants' maximum expiratory pressure and maximum inspiratory pressure. Participants will complete training 5 days per week by performing 5 sets of 5 repetitions for both expiratory and inspiratory muscle strength training (a total of 50 repetitions).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to respiratory strength training | Number of respiratory strength training repetitions/1000 | 4 weeks | 
| Attendance at Telehealth sessions | Number of Telehealth sessions completed/4 | 4 weeks | 
| Change in maximum expiratory pressure between pre and post respiratory strength training | A measure of respiratory strength while breathing out | 4 weeks | 
| Change in maximum inspiratory pressure between pre and post respiratory strength training | A measure of respiratory strength while breathing in | 4 weeks | 
| Change in cough peak expiratory flow between pre and post respiratory strength training | A measure of cough strength | 4 weeks | 
| Change in penetration-aspiration scale scores between pre and post respiratory strength training and between before and after surgery | The penetration aspiration scale is a validated 8-point ordinal rating scale that measures the depth of airway invasion and the patient's response during swallowing. Scores range from 1 to 8 with a score of 1 indicating a safe swallow (best score) and 8 indicating silent aspiration (worst score). | 5 weeks |