Skip to content

Respiratory Strength Training in Cardiac Surgical Patients

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04887415
Enrollment
25
Registered
2021-05-14
Start date
2021-09-02
Completion date
2023-01-23
Last updated
2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief 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.

Detailed description

Enrolled research participants will undergo baseline assessments of pulmonary function: maximum expiratory pressure (MEP), maximum inspiratory pressure (MIP), cough function (voluntary PEF and cough spirometry), and will complete self-reported dyspnea using the validated London Chest Activity of Daily Living (LCADL) scale. Following baseline testing, participants will complete a respiratory strength training program (RST) in the home via telehealth with one in-person home therapy session conducted at each participant's midpoint to reassess MEP and MIP and to recalibrate the respiratory strength trainer devices. After the prescribed RST program, participants will complete a second post-RST preoperative assessment. All pulmonary function measures will be performed by a research SLP in accordance with standardized protocols and guidelines from the American Thoracic Society 12-14 with research participants in an upright seated position with nose clips in place. A swallowing examination (FEES) will be completed both pre and post surgery to assess any impact on swallowing safety. Respiratory Assessment: MEP and MIP measurements will be obtained using a MicroRPM handheld menometry device (MicroDirect). For MEP testing, research participants will be instructed to take a deep breath in, place their mouth around the mouthpiece, and blow out as forcefully as possible. As needed, the research SLP will assist with lip seal by holding the sides of participant's cheeks to prevent air leakage. For MIP testing, research participants will be instructed to expel all the air out of their lungs, place their mouth around the mouthpiece, and breathe in as forcefully as possible. Each participant will perform 3 MEP and MIP trials. Average MEP and MIP values will be used to calibrate expiratory and inspiratory devices and for subsequent analyses. Respiratory Strength Training (RST) Program: The RST program consists of expiratory muscle strength training (EMST) and inspiratory muscle strength training (IMST) using the EMST-75 Lite or the EMST-150 and the IA-150 devices (Aspire Products), respectively. Trainer devices will be calibrated to a 50% load of individualized MEP and MIP values. The CS patients will perform 25 repetitions each (5 sets of 5 repetitions) of the expiratory and inspiratory exercises, 5 days/week leading up to their surgical procedure. The patients will be given training logs to track completion of the RST exercises to measure adherence. Telehealth sessions: Telehealth sessions will be conducted by a research speech-language pathologist (SLP) at least once per week via a secure version of Zoom. During telehealth sessions, the research SLP will ensure that participants performed the prescribed exercises with correct form, completed a safety and adverse event check, answered participant questions, assisted with adherence issues, monitored adverse events, and aided participants in adjusting the resistance of the expiratory and inspiratory training devices based on participant exertion ratings using the Borg Category Ratio 10 Scale.11 During the adverse event check, the research SLP will ask research participants if they were experiencing any pain, fatigue, discomfort, or other adverse events related to the RST protocol. Attendance for telehealth sessions will be tracked. Home Visits: In addition to weekly telehealth sessions, a home visit will be conducted by a research SLP midway through the RST program. During the home visit, the research SLP will perform check-ins similar to telehealth sessions, retest MEP and MIP, and recalibrate the training devices to meet the 50% training load target. Fiberoptic Endoscopic Evaluation of Swallowing (FEES): Participants will undergo a FEES exam in a dedicated room in the preoperative clinic or the ARC lab before and after completing the RST program using an Olympus flexible video HD Rhino Laryngoscope connected to a portable video processor and light source. To ensure patient comfort, a water-soluble lubricant and, per participant preference, a topical numbing-agent (i.e., lidocaine) will be applied to the naris, and the laryngoscope will be passed trans-nasally through the nasopharynx and hypopharynx until an optimal position is obtained. A standardized FEES protocol will be used that includes a combination of voicing and swallowing tasks. At the completion of the swallowing trials, the laryngoscope will be carefully removed. Blinded analysis of the swallowing exam will be performed. Statistical Analysis: Demographic information and pulmonary and cough function data will be exported directly from our secure online database, REDCap, into JMP version 16.1.020 and Prism version 9.4.1 (GraphPad Software) for statistical analyses. Descriptive statistics will be used to summarize demographic information and pulmonary and cough function data. Intraclass correlation coefficients (ICCs) with 95%confidence intervals (CI) will be used to calculate inter-rater and intrarater reliability for voluntary cough spirometry metrics. Mean differences with 95% CIs will be calculated, and the Wilcoxon signed-rank test will be performed to assess pre-RST to post-RST changes in pulmonary and cough function.

Interventions

BEHAVIORALRespiratory 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.

Sponsors

American Speech-Language-Hearing Foundation
CollaboratorOTHER
American Heart Association
CollaboratorOTHER
University of Florida
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

Longitudinal pilot cohort study

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

1. Adult 18-90 years old. 2. Not pregnant. 3. Undergoing planned cardiac surgery via sternotomy &/or extended thoracotomy & seen in the UF Health preoperative clinic. 4. Confirmed COVID-19 negative test and/or no recent COVID-19 symptoms 5. Has access to a computer, tablet, or electronic device with a stable internet connection for telehealth sessions. 6. Willing to undergo testing procedures and complete the exercise training program

Exclusion criteria

1. Individuals under the age of 18 or over the age of 90. 2. Pregnant women. 3. Positive for COVID-19 or symptoms of COVID-19 4. No access to a computer, tablet, or electronic device &/ a stable internet connection for telehealth sessions. 5. Unwilling to undergo testing procedures and/or complete the exercise training program.

Design outcomes

Primary

MeasureTime frameDescription
Adherence to Respiratory Strength Training4 weeksNumber of respiratory strength training repetitions
Attendance at Telehealth Sessions4 weeksNumber of Telehealth sessions completed
Change in Maximum Expiratory Pressure (MEP) Between Pre and Post Respiratory Strength Training4 weeksA measure of maximum expiratory respiratory strength (in cmH2O) prior to and after completing RST program.
Change in Maximum Inspiratory Pressure (MIP) Pre and Post Respiratory Strength Training4 weeksA measure of maximum inspiratory strength (in cmH2O) prior to and after completing RST program.
Change in Cough Peak Expiratory Flow Between Pre and Post Respiratory Strength Training4 weeksA measure of cough strength (in L/min of air flow) prior to and after completing RST program.
Change in Worst Penetration-aspiration Scale (PAS) Score From Pre and Post Surgical Fiberoptic Endoscopic Evaluation of Swallowing (FEES).5 weeksThe 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
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.
25
Total25

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyLost to Follow-up2

Baseline characteristics

CharacteristicEnrolled Participants
Age, Continuous67.9 years
STANDARD_DEVIATION 11.3
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
22 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
2 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
1 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
2 Participants
Race (NIH/OMB)
White
22 Participants
Sex: Female, Male
Female
11 Participants
Sex: Female, Male
Male
14 Participants
Surgery Type
Aorta Graft
3 Participants
Surgery Type
Aortic Arch
3 Participants
Surgery Type
Aortic Root
1 Participants
Surgery Type
Atrial Appendage Ligation with an Atriclip
1 Participants
Surgery Type
CABG
1 Participants
Surgery Type
LVAD
1 Participants
Surgery Type
Maze Procedure
3 Participants
Surgery Type
Mini Aortic Valve
1 Participants
Surgery Type
Mitral Valve
8 Participants
Surgery Type
Multiple Valve Replacement
2 Participants
Surgery Type
Tricuspid Valve
1 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 25
other
Total, other adverse events
8 / 25
serious
Total, serious adverse events
0 / 25

Outcome results

Primary

Adherence to Respiratory Strength Training

Number of respiratory strength training repetitions

Time frame: 4 weeks

ArmMeasureValue (COUNT_OF_UNITS)
Enrolled ParticipantsAdherence to Respiratory Strength Training35750 Repetitions
Primary

Attendance at Telehealth Sessions

Number of Telehealth sessions completed

Time frame: 4 weeks

ArmMeasureValue (COUNT_OF_UNITS)
Enrolled ParticipantsAttendance at Telehealth Sessions135 Telehealth Sessions
Primary

Change in Cough Peak Expiratory Flow Between Pre and Post Respiratory Strength Training

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

Time frame: 4 weeks

ArmMeasureGroupValue (MEAN)Dispersion
Enrolled ParticipantsChange in Cough Peak Expiratory Flow Between Pre and Post Respiratory Strength TrainingPre-RST337.7 L/minStandard Deviation 128.5
Enrolled ParticipantsChange in Cough Peak Expiratory Flow Between Pre and Post Respiratory Strength TrainingPost-RST352.7 L/minStandard Deviation 144.3
Primary

Change in Maximum Expiratory Pressure (MEP) Between Pre and Post Respiratory Strength Training

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

Time frame: 4 weeks

ArmMeasureGroupValue (MEAN)Dispersion
Enrolled ParticipantsChange in Maximum Expiratory Pressure (MEP) Between Pre and Post Respiratory Strength TrainingPre-RST105.6 cmH2OStandard Deviation 40.9
Enrolled ParticipantsChange in Maximum Expiratory Pressure (MEP) Between Pre and Post Respiratory Strength TrainingPost-RST120.9 cmH2OStandard Deviation 49.7
Primary

Change in Maximum Inspiratory Pressure (MIP) Pre and Post Respiratory Strength Training

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

Time frame: 4 weeks

ArmMeasureGroupValue (MEAN)Dispersion
Enrolled ParticipantsChange in Maximum Inspiratory Pressure (MIP) Pre and Post Respiratory Strength TrainingPre-RST73.2 cmH2OStandard Deviation 26.4
Enrolled ParticipantsChange in Maximum Inspiratory Pressure (MIP) Pre and Post Respiratory Strength TrainingPost-RST88.1 cmH2OStandard Deviation 30.9
Primary

Change in Worst Penetration-aspiration Scale (PAS) Score From Pre and Post Surgical Fiberoptic Endoscopic Evaluation of Swallowing (FEES).

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.

Time frame: 5 weeks

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Enrolled ParticipantsChange in Worst Penetration-aspiration Scale (PAS) Score From Pre and Post Surgical Fiberoptic Endoscopic Evaluation of Swallowing (FEES).Worst PAS Score = 113 Participants
Enrolled ParticipantsChange in Worst Penetration-aspiration Scale (PAS) Score From Pre and Post Surgical Fiberoptic Endoscopic Evaluation of Swallowing (FEES).Worst PAS Score = 21 Participants
Enrolled ParticipantsChange in Worst Penetration-aspiration Scale (PAS) Score From Pre and Post Surgical Fiberoptic Endoscopic Evaluation of Swallowing (FEES).Worst PAS Score = 34 Participants
Enrolled ParticipantsChange in Worst Penetration-aspiration Scale (PAS) Score From Pre and Post Surgical Fiberoptic Endoscopic Evaluation of Swallowing (FEES).Worst PAS Score = 42 Participants
Enrolled ParticipantsChange in Worst Penetration-aspiration Scale (PAS) Score From Pre and Post Surgical Fiberoptic Endoscopic Evaluation of Swallowing (FEES).Worst PAS Score = 51 Participants
Enrolled ParticipantsChange in Worst Penetration-aspiration Scale (PAS) Score From Pre and Post Surgical Fiberoptic Endoscopic Evaluation of Swallowing (FEES).Worst PAS Score = 60 Participants
Enrolled ParticipantsChange in Worst Penetration-aspiration Scale (PAS) Score From Pre and Post Surgical Fiberoptic Endoscopic Evaluation of Swallowing (FEES).Worst PAS Score = 70 Participants
Enrolled ParticipantsChange in Worst Penetration-aspiration Scale (PAS) Score From Pre and Post Surgical Fiberoptic Endoscopic Evaluation of Swallowing (FEES).Worst PAS Score = 82 Participants
Enrolled Participants - Post-Operative PAS OutcomesChange in Worst Penetration-aspiration Scale (PAS) Score From Pre and Post Surgical Fiberoptic Endoscopic Evaluation of Swallowing (FEES).Worst PAS Score = 85 Participants
Enrolled Participants - Post-Operative PAS OutcomesChange in Worst Penetration-aspiration Scale (PAS) Score From Pre and Post Surgical Fiberoptic Endoscopic Evaluation of Swallowing (FEES).Worst PAS Score = 12 Participants
Enrolled Participants - Post-Operative PAS OutcomesChange in Worst Penetration-aspiration Scale (PAS) Score From Pre and Post Surgical Fiberoptic Endoscopic Evaluation of Swallowing (FEES).Worst PAS Score = 54 Participants
Enrolled Participants - Post-Operative PAS OutcomesChange in Worst Penetration-aspiration Scale (PAS) Score From Pre and Post Surgical Fiberoptic Endoscopic Evaluation of Swallowing (FEES).Worst PAS Score = 20 Participants
Enrolled Participants - Post-Operative PAS OutcomesChange in Worst Penetration-aspiration Scale (PAS) Score From Pre and Post Surgical Fiberoptic Endoscopic Evaluation of Swallowing (FEES).Worst PAS Score = 71 Participants
Enrolled Participants - Post-Operative PAS OutcomesChange in Worst Penetration-aspiration Scale (PAS) Score From Pre and Post Surgical Fiberoptic Endoscopic Evaluation of Swallowing (FEES).Worst PAS Score = 39 Participants
Enrolled Participants - Post-Operative PAS OutcomesChange in Worst Penetration-aspiration Scale (PAS) Score From Pre and Post Surgical Fiberoptic Endoscopic Evaluation of Swallowing (FEES).Worst PAS Score = 61 Participants
Enrolled Participants - Post-Operative PAS OutcomesChange in Worst Penetration-aspiration Scale (PAS) Score From Pre and Post Surgical Fiberoptic Endoscopic Evaluation of Swallowing (FEES).Worst PAS Score = 40 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026