CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 25 enrolled
Drug / intervention
Respiratory Strength Training (RST) Programbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04887415
NCT04887415N/ACompleted

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

University of Florida·interventional·Posted May 14, 2021·Updated Aug 19, 2024

In Brief

A clinical study evaluating Respiratory Strength Training (RST) Program for Cardiovascular Diseases and 4 related conditions. Completed, enrolled 25 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20222023202420252026
First PostedMay 14, 2021
Enrollment StartSep 2, 2021
Primary CompletionJan 23, 2023
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 5.1 years ago

Interventions

Respiratory Strength Training (RST) Programbehavioral

Participants will complete RST exercises 5 days per week by performing 5 sets of 5 repetitions of both expiratory and inspiratory muscle strength training (a total of 50 repetitions per day). Trainer devices will be calibrated to 50% of participants' maximum expiratory pressure (MEP) and maximum inspiratory pressure (MIP) as determined via respiratory assessment prior to and during the RST program.