Trial Outcomes & Findings for Respiratory Strength Training in Cardiac Surgical Patients (NCT NCT04887415)

NCT ID: NCT04887415

Last Updated: 2024-08-19

Results Overview

Number of respiratory strength training repetitions

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 25 participants
• Primary outcome timeframe: 4 weeks
• Results posted on: 2024-08-19

Participant Flow

Participant milestones

Measure	Enrolled Participants Enrolled cardiac surgical patients who underwent a 4 weeks of preoperative respiratory strength training (RST) program using two respiratory strength training devices. Respiratory Strength Training (RST) Program: 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.
Overall Study STARTED	25
Overall Study COMPLETED	23
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure

Enrolled Participants Enrolled cardiac surgical patients who underwent a 4 weeks of preoperative respiratory strength training (RST) program using two respiratory strength training devices. Respiratory Strength Training (RST) Program: 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.

Overall Study Lost to Follow-up

2

Baseline Characteristics

Respiratory Strength Training in Cardiac Surgical Patients

Baseline characteristics by cohort

Measure	Enrolled Participants n=25 Participants Enrolled cardiac surgical patients who underwent a 4 weeks of preoperative respiratory strength training (RST) program using two respiratory strength training devices. Respiratory Strength Training (RST) Program: 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.
Age, Continuous	67.9 years STANDARD_DEVIATION 11.3 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	22 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	22 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Surgery Type Mitral Valve	8 Participants n=5 Participants
Surgery Type Aorta Graft	3 Participants n=5 Participants
Surgery Type Aortic Arch	3 Participants n=5 Participants
Surgery Type Maze Procedure	3 Participants n=5 Participants
Surgery Type Multiple Valve Replacement	2 Participants n=5 Participants
Surgery Type Aortic Root	1 Participants n=5 Participants
Surgery Type CABG	1 Participants n=5 Participants
Surgery Type LVAD	1 Participants n=5 Participants
Surgery Type Tricuspid Valve	1 Participants n=5 Participants
Surgery Type Mini Aortic Valve	1 Participants n=5 Participants
Surgery Type Atrial Appendage Ligation with an Atriclip	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks

Number of respiratory strength training repetitions

Outcome measures

Measure	Enrolled Participants n=36650 Repetitions Enrolled cardiac surgical patients who underwent a 4 weeks of preoperative respiratory strength training (RST) program using two respiratory strength training devices. Respiratory Strength Training (RST) Program: 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.	Enrolled Participants - Post-Operative PAS Outcomes Enrolled cardiac surgical patients who underwent a 4 weeks of preoperative respiratory strength training (RST) program using two respiratory strength training devices. A fiberoptic endoscopic evaluation of swallowing (FEES) was performed after their scheduled cardiac surgery. Analysis of the FEES procedure included evaluation of the worst overall PAS score during the FEES examination.
Adherence to Respiratory Strength Training	35750 Repetitions	—

PRIMARY outcome

Timeframe: 4 weeks

Number of Telehealth sessions completed

Outcome measures

Measure	Enrolled Participants n=135 Telehealth Sessions Enrolled cardiac surgical patients who underwent a 4 weeks of preoperative respiratory strength training (RST) program using two respiratory strength training devices. Respiratory Strength Training (RST) Program: 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.	Enrolled Participants - Post-Operative PAS Outcomes Enrolled cardiac surgical patients who underwent a 4 weeks of preoperative respiratory strength training (RST) program using two respiratory strength training devices. A fiberoptic endoscopic evaluation of swallowing (FEES) was performed after their scheduled cardiac surgery. Analysis of the FEES procedure included evaluation of the worst overall PAS score during the FEES examination.
Attendance at Telehealth Sessions	135 Telehealth Sessions	—

PRIMARY outcome

Timeframe: 4 weeks

A measure of maximum expiratory respiratory strength (in cmH2O) prior to and after completing RST program.

Outcome measures

Measure	Enrolled Participants n=23 Participants Enrolled cardiac surgical patients who underwent a 4 weeks of preoperative respiratory strength training (RST) program using two respiratory strength training devices. Respiratory Strength Training (RST) Program: 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.	Enrolled Participants - Post-Operative PAS Outcomes Enrolled cardiac surgical patients who underwent a 4 weeks of preoperative respiratory strength training (RST) program using two respiratory strength training devices. A fiberoptic endoscopic evaluation of swallowing (FEES) was performed after their scheduled cardiac surgery. Analysis of the FEES procedure included evaluation of the worst overall PAS score during the FEES examination.
Change in Maximum Expiratory Pressure (MEP) Between Pre and Post Respiratory Strength Training Pre-RST	105.6 cmH2O Standard Deviation 40.9	—
Change in Maximum Expiratory Pressure (MEP) Between Pre and Post Respiratory Strength Training Post-RST	120.9 cmH2O Standard Deviation 49.7	—

PRIMARY outcome

Timeframe: 4 weeks

A measure of maximum inspiratory strength (in cmH2O) prior to and after completing RST program.

Outcome measures

Measure	Enrolled Participants n=23 Participants Enrolled cardiac surgical patients who underwent a 4 weeks of preoperative respiratory strength training (RST) program using two respiratory strength training devices. Respiratory Strength Training (RST) Program: 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.	Enrolled Participants - Post-Operative PAS Outcomes Enrolled cardiac surgical patients who underwent a 4 weeks of preoperative respiratory strength training (RST) program using two respiratory strength training devices. A fiberoptic endoscopic evaluation of swallowing (FEES) was performed after their scheduled cardiac surgery. Analysis of the FEES procedure included evaluation of the worst overall PAS score during the FEES examination.
Change in Maximum Inspiratory Pressure (MIP) Pre and Post Respiratory Strength Training Pre-RST	73.2 cmH2O Standard Deviation 26.4	—
Change in Maximum Inspiratory Pressure (MIP) Pre and Post Respiratory Strength Training Post-RST	88.1 cmH2O Standard Deviation 30.9	—

PRIMARY outcome

Timeframe: 4 weeks

A measure of cough strength (in L/min of air flow) prior to and after completing RST program.

Outcome measures

Measure	Enrolled Participants n=23 Participants Enrolled cardiac surgical patients who underwent a 4 weeks of preoperative respiratory strength training (RST) program using two respiratory strength training devices. Respiratory Strength Training (RST) Program: 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.	Enrolled Participants - Post-Operative PAS Outcomes Enrolled cardiac surgical patients who underwent a 4 weeks of preoperative respiratory strength training (RST) program using two respiratory strength training devices. A fiberoptic endoscopic evaluation of swallowing (FEES) was performed after their scheduled cardiac surgery. Analysis of the FEES procedure included evaluation of the worst overall PAS score during the FEES examination.
Change in Cough Peak Expiratory Flow Between Pre and Post Respiratory Strength Training Pre-RST	337.7 L/min Standard Deviation 128.5	—
Change in Cough Peak Expiratory Flow Between Pre and Post Respiratory Strength Training Post-RST	352.7 L/min Standard Deviation 144.3	—

PRIMARY outcome

Timeframe: 5 weeks

The Penetration-Aspiration Scale (PAS) is a validated 8-point ordinal rating scale that measures the depth of airway invasion of bolus material and patient response during swallowing. PAS scores range from 1 to 8, with a score of 1 indicating a safe swallow (no penetration or aspiration of bolus material) (best score) and 8 indicating silent aspiration (bolus material reached below the level of the vocal folds and no response / effort to eject material was made) (worst score). After analysis of the FEES examination, the worst overall PAS score across was determined across all bolus types administered during the exam and recorded for both the preoperative FEES exam and the post-operative FEES exam.

Outcome measures

Measure	Enrolled Participants n=23 Participants Enrolled cardiac surgical patients who underwent a 4 weeks of preoperative respiratory strength training (RST) program using two respiratory strength training devices. Respiratory Strength Training (RST) Program: 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.	Enrolled Participants - Post-Operative PAS Outcomes n=22 Participants Enrolled cardiac surgical patients who underwent a 4 weeks of preoperative respiratory strength training (RST) program using two respiratory strength training devices. A fiberoptic endoscopic evaluation of swallowing (FEES) was performed after their scheduled cardiac surgery. Analysis of the FEES procedure included evaluation of the worst overall PAS score during the FEES examination.
Change in Worst Penetration-aspiration Scale (PAS) Score From Pre and Post Surgical Fiberoptic Endoscopic Evaluation of Swallowing (FEES). Worst PAS Score = 1	13 Participants	2 Participants
Change in Worst Penetration-aspiration Scale (PAS) Score From Pre and Post Surgical Fiberoptic Endoscopic Evaluation of Swallowing (FEES). Worst PAS Score = 2	1 Participants	0 Participants
Change in Worst Penetration-aspiration Scale (PAS) Score From Pre and Post Surgical Fiberoptic Endoscopic Evaluation of Swallowing (FEES). Worst PAS Score = 3	4 Participants	9 Participants
Change in Worst Penetration-aspiration Scale (PAS) Score From Pre and Post Surgical Fiberoptic Endoscopic Evaluation of Swallowing (FEES). Worst PAS Score = 4	2 Participants	0 Participants
Change in Worst Penetration-aspiration Scale (PAS) Score From Pre and Post Surgical Fiberoptic Endoscopic Evaluation of Swallowing (FEES). Worst PAS Score = 5	1 Participants	4 Participants
Change in Worst Penetration-aspiration Scale (PAS) Score From Pre and Post Surgical Fiberoptic Endoscopic Evaluation of Swallowing (FEES). Worst PAS Score = 6	0 Participants	1 Participants
Change in Worst Penetration-aspiration Scale (PAS) Score From Pre and Post Surgical Fiberoptic Endoscopic Evaluation of Swallowing (FEES). Worst PAS Score = 7	0 Participants	1 Participants
Change in Worst Penetration-aspiration Scale (PAS) Score From Pre and Post Surgical Fiberoptic Endoscopic Evaluation of Swallowing (FEES). Worst PAS Score = 8	2 Participants	5 Participants

Adverse Events

Enrolled Participants

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Enrolled Participants n=25 participants at risk Enrolled cardiac surgical patients who underwent a 4 weeks of preoperative respiratory strength training (RST) program using two respiratory strength training devices. Respiratory Strength Training (RST) Program: 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.
General disorders Pain (mild)	8.0% 2/25 • Number of events 25 • From participant enrollment date through study completion (participant is discharged from hospital following cardiac surgery), an average of 8 weeks.
General disorders Dizziness	28.0% 7/25 • Number of events 25 • From participant enrollment date through study completion (participant is discharged from hospital following cardiac surgery), an average of 8 weeks.
General disorders Migraine	4.0% 1/25 • Number of events 25 • From participant enrollment date through study completion (participant is discharged from hospital following cardiac surgery), an average of 8 weeks.
Respiratory, thoracic and mediastinal disorders Dry Throat	4.0% 1/25 • Number of events 25 • From participant enrollment date through study completion (participant is discharged from hospital following cardiac surgery), an average of 8 weeks.
Respiratory, thoracic and mediastinal disorders Bloody Nose	4.0% 1/25 • Number of events 25 • From participant enrollment date through study completion (participant is discharged from hospital following cardiac surgery), an average of 8 weeks.

Additional Information

Emily K. Plowman, Ph.D. CCC-SLP

University of Florida

Phone: (352)273-8632

Email: eplowman@ufl.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place