Respiratory Strength Training in Cardiac Surgical Patients

NCT04887415 | Completed Results

• 2 other identifiers: IRB202100993OCR40654
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases; Thoracic Diseases; Surgery; Surgery--Complications; Dysphagia

Outcome Measures

Primary Outcomes (6)

• Adherence to Respiratory Strength Training

  Number of respiratory strength training repetitions

  4 weeks

• Attendance at Telehealth Sessions

  Number of Telehealth sessions completed

  4 weeks

• 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.

  4 weeks

• 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.

  4 weeks

• 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.

  4 weeks

• 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.

  5 weeks

Study Arms (1)

Enrolled Participants

EXPERIMENTAL

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

Respiratory Strength Training (RST) Program BEHAVIORAL

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

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Florida: lead
• American Speech-Language-Hearing Foundation: collaborator
• American Heart Association: collaborator

Study Sites (1)

Cardiovascular Clinic and Thoracic/Cardiovascular Surgery at UF Health

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Thoracic Diseases; Deglutition Disorders

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Results Point of Contact

• Title: Emily K. Plowman, Ph.D. CCC-SLP
• Organization: University of Florida

eplowman@ufl.edu

(352)273-8632

Study Officials

• Emily Plowman, Ph.D.

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Longitudinal pilot cohort study

Study Record Dates

• First Submitted: May 10, 2021
• First Posted: May 14, 2021
• Study Start: September 2, 2021
• Primary Completion: January 23, 2023
• Study Completion: January 23, 2023
• Last Updated: August 19, 2024
• Results First Posted: August 19, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)