N/A
N=25
Respiratory Strength Training in Cardiac Surgical Patients
Cardiovascular Diseases · Thoracic Diseases · Surgery · Surgery--Complications · Dysphagia
Bottom Line
View on ClinicalTrials.gov: NCT04887415 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcome: Primary: Adherence to Respiratory Strength Training — 35750 Repetitions
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Respiratory Strength Training (RST) Program (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Florida
- Primary completion
- Jan 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adherence to Respiratory Strength Training |
35750 | — |
| PRIMARY Attendance at Telehealth Sessions |
135 | — |
| PRIMARY Change in Maximum Expiratory Pressure (MEP) Between Pre and Post Respiratory Strength Training |
105.6; 120.9 | — |
| PRIMARY Change in Maximum Inspiratory Pressure (MIP) Pre and Post Respiratory Strength Training |
73.2; 88.1 | — |
| PRIMARY Change in Cough Peak Expiratory Flow Between Pre and Post Respiratory Strength Training |
337.7; 352.7 | — |
| PRIMARY Change in Worst Penetration-aspiration Scale (PAS) Score From Pre and Post Surgical Fiberoptic Endoscopic Evaluation of Swallowing (FEES). |
13; 2; 1; 0; 4; 9 | — |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04887415). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.