Respiratory Strength Training in Cardiac Surgical Patients

Sponsor
University of Florida (Other)
Overall Status
Recruiting
CT.gov ID
NCT04887415
Collaborator
American Speech Language Hearing Foundation (ASHFoundation) (Other), American Heart Association (Other)
25
1
1
17
1.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Respiratory strength training
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
25 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Longitudinal pilot cohort studyLongitudinal pilot cohort study
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Safety, Feasibility, and Impact of Preoperative Respiratory Strength Training in Cardiac Surgical Patients
Actual Study Start Date :
Sep 2, 2021
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Feb 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Respiratory strength training

Enrolled cardiac surgical patients will undergo 4 weeks of preoperative respiratory strength training using two respiratory strength training devices.

Device: Respiratory strength training
Devices will be set to 70% of participants' maximum expiratory pressure and maximum inspiratory pressure. Participants will complete training 5 days per week by performing 5 sets of 5 repetitions for both expiratory and inspiratory muscle strength training (a total of 50 repetitions).

Outcome Measures

Primary Outcome Measures

  1. Adherence to respiratory strength training [4 weeks]

    Number of respiratory strength training repetitions/1000

  2. Attendance at Telehealth sessions [4 weeks]

    Number of Telehealth sessions completed/4

  3. Change in maximum expiratory pressure between pre and post respiratory strength training [4 weeks]

    A measure of respiratory strength while breathing out

  4. Change in maximum inspiratory pressure between pre and post respiratory strength training [4 weeks]

    A measure of respiratory strength while breathing in

  5. Change in cough peak expiratory flow between pre and post respiratory strength training [4 weeks]

    A measure of cough strength

  6. Change in penetration-aspiration scale scores between pre and post respiratory strength training and between before and after surgery [5 weeks]

    The penetration aspiration scale is a validated 8-point ordinal rating scale that measures the depth of airway invasion and the patient's response during swallowing. Scores range from 1 to 8 with a score of 1 indicating a safe swallow (best score) and 8 indicating silent aspiration (worst score).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cardiovascular Clinic and Thoracic/Cardiovascular Surgery at UF Health Gainesville Florida United States 32610

Sponsors and Collaborators

  • University of Florida
  • American Speech Language Hearing Foundation (ASHFoundation)
  • American Heart Association

Investigators

  • Principal Investigator: Emily Plowman, Ph.D., University of Florida

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Florida
ClinicalTrials.gov Identifier:
NCT04887415
Other Study ID Numbers:
  • IRB202100993
  • OCR40654
First Posted:
May 14, 2021
Last Update Posted:
Jan 28, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 28, 2022