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CompletedNCT04887415Updated Aug 19, 2024Results posted

Respiratory Strength Training in Cardiac Surgical Patients

An interventional study of Respiratory Strength Training (RST) Program in Cardiovascular Diseases, Thoracic Diseases and Surgery, sponsored by University of Florida. Completed at 1 site in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2024-08-19.

Sponsored by University of Florida · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Not applicable
Ages
18 Years to 90 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Cardiovascular Diseases
  • Thoracic Diseases
  • Surgery
  • Surgery--Complications
  • Dysphagia
03

In context

Cardiovascular Diseases

5,025 studies on the registry are indexed under Cardiovascular Diseases; 930 are open to participants now.

This study's enrollment of 25 is below the median of 100 across 2,801 interventional studies indexed under Cardiovascular Diseases.

Browse Cardiovascular Diseases studies →

Lead sponsor

University of Florida is the lead sponsor of 1,285 studies on the registry; 199 are open to participants now.

Of its 177 completed or terminated interventional studies of FDA-regulated products, 141 (80%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
25 participants (actual)

Study arms

  • Experimental
    Enrolled Participants

    Enrolled cardiac surgical patients who underwent a 4 weeks of preoperative respiratory strength training (RST) program using two respiratory strength training devices.

    Behavioral: Respiratory Strength Training (RST) Program

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.

06

What researchers measure

Primary outcomes

  1. Adherence to Respiratory Strength Training

    Number of respiratory strength training repetitions

    Time frame: 4 weeks

  2. Attendance at Telehealth Sessions

    Number of Telehealth sessions completed

    Time frame: 4 weeks

  3. 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

  4. 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

  5. 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

  6. 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

07

Results

Posted Aug 19, 2024

Participant flow

Participant flow — Overall Study
MilestoneEnrolled Participants
Started25
Completed23
Not completed2
Withdrew: Lost to follow-up2

Outcome measures

PrimaryAdherence to Respiratory Strength Training

Number of respiratory strength training repetitions

Time frame:
4 weeks
Reported as:
Count of units · Repetitions
Adherence to Respiratory Strength Training
RepetitionsEnrolled Participants
Adherence to Respiratory Strength Training35750
PrimaryAttendance at Telehealth Sessions

Number of Telehealth sessions completed

Time frame:
4 weeks
Reported as:
Count of units · Telehealth Sessions
Attendance at Telehealth Sessions
Telehealth SessionsEnrolled Participants
Attendance at Telehealth Sessions135
PrimaryChange 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
Reported as:
Mean · cmH2O
Change in Maximum Expiratory Pressure (MEP) Between Pre and Post Respiratory Strength Training
cmH2OEnrolled Participants
Pre-RST105.6 ± 40.9
Post-RST120.9 ± 49.7
PrimaryChange 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
Reported as:
Mean · cmH2O
Change in Maximum Inspiratory Pressure (MIP) Pre and Post Respiratory Strength Training
cmH2OEnrolled Participants
Pre-RST73.2 ± 26.4
Post-RST88.1 ± 30.9
PrimaryChange 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
Reported as:
Mean · L/min
Change in Cough Peak Expiratory Flow Between Pre and Post Respiratory Strength Training
L/minEnrolled Participants
Pre-RST337.7 ± 128.5
Post-RST352.7 ± 144.3
PrimaryChange 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
Reported as:
Count of participants · Participants
Change in Worst Penetration-aspiration Scale (PAS) Score From Pre and Post Surgical Fiberoptic Endoscopic Evaluation of Swallowing (FEES).
ParticipantsEnrolled Participants - Preoperative PAS OutcomesEnrolled Participants - Post-Operative PAS Outcomes
Worst PAS Score = 1132
Worst PAS Score = 210
Worst PAS Score = 349
Worst PAS Score = 420
Worst PAS Score = 514
Worst PAS Score = 601
Worst PAS Score = 701
Worst PAS Score = 825

Adverse events

Collected over From participant enrollment date through study completion (participant is discharged from hospital following cardiac surgery), an average of 8 weeks.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Enrolled Participants0/25 (0%)0/25 (0%)8/25 (32%)
Most frequent other events
Most frequent other events
EventEnrolled Participants
DizzinessGeneral disorders7/25
Pain (mild)General disorders2/25
MigraineGeneral disorders1/25
Dry ThroatRespiratory, thoracic and mediastinal disorders1/25
Bloody NoseRespiratory, thoracic and mediastinal disorders1/25

Baseline characteristics

Age, Continuous
Age, Continuous(years)Enrolled Participants
Mean67.9 ± 11.3
Sex: Female, Male
Sex: Female, Male(Participants)Enrolled Participants
Female11
Male14
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Enrolled Participants
Hispanic or Latino1
Not Hispanic or Latino22
Unknown or Not Reported2
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Enrolled Participants
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American1
White22
More than one race0
Unknown or Not Reported2
Surgery Type
Surgery Type(Participants)Enrolled Participants
Mitral Valve8
Aorta Graft3
Aortic Arch3
Maze Procedure3
Multiple Valve Replacement2
Aortic Root1
CABG1
LVAD1
Tricuspid Valve1
Mini Aortic Valve1
Atrial Appendage Ligation with an Atriclip1
08

Study locations

1 site
  • Cardiovascular Clinic and Thoracic/Cardiovascular Surgery at UF Health
    Gainesville, Florida 32610, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Apr 10, 2022
  • Informed consent form · May 17, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04887415
Collaborators
American Speech-Language-Hearing Foundation, American Heart Association
Responsible party
Sponsor
First posted
May 14, 2021
Start date
Sep 2, 2021
Primary completion
Jan 23, 2023
Completion
Jan 23, 2023
Results posted
Aug 19, 2024
Last update
Aug 19, 2024

Study contacts

Emily Plowman, Ph.D.
principal investigator · University of Florida

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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