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Respiratory Strength Training in Cardiac Surgical Patients

Primary Purpose

Cardiovascular Diseases, Thoracic Diseases, Surgery

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Respiratory strength training
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cardiovascular Diseases

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Cardiovascular Clinic and Thoracic/Cardiovascular Surgery at UF HealthRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Respiratory strength training

Arm Description

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

Outcomes

Primary Outcome Measures

Adherence to respiratory strength training
Number of respiratory strength training repetitions/1000
Attendance at Telehealth sessions
Number of Telehealth sessions completed/4
Change in maximum expiratory pressure between pre and post respiratory strength training
A measure of respiratory strength while breathing out
Change in maximum inspiratory pressure between pre and post respiratory strength training
A measure of respiratory strength while breathing in
Change in cough peak expiratory flow between pre and post respiratory strength training
A measure of cough strength
Change in penetration-aspiration scale scores between pre and post respiratory strength training and between before and after surgery
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).

Secondary Outcome Measures

Full Information

First Posted
May 10, 2021
Last Updated
January 13, 2022
Sponsor
University of Florida
Collaborators
American Speech Language Hearing Foundation (ASHFoundation), American Heart Association
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1. Study Identification

Unique Protocol Identification Number
NCT04887415
Brief Title
Respiratory Strength Training in Cardiac Surgical Patients
Official Title
Safety, Feasibility, and Impact of Preoperative Respiratory Strength Training in Cardiac Surgical Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 2, 2021 (Actual)
Primary Completion Date
October 2022 (Anticipated)
Study Completion Date
February 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
American Speech Language Hearing Foundation (ASHFoundation), American Heart Association

4. Oversight

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
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Thoracic Diseases, Surgery, Surgery--Complications, Dysphagia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Longitudinal pilot cohort study
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Respiratory strength training
Arm Type
Experimental
Arm Description
Enrolled cardiac surgical patients will undergo 4 weeks of preoperative respiratory strength training using two respiratory strength training devices.
Intervention Type
Device
Intervention Name(s)
Respiratory strength training
Intervention Description
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).
Primary Outcome Measure Information:
Title
Adherence to respiratory strength training
Description
Number of respiratory strength training repetitions/1000
Time Frame
4 weeks
Title
Attendance at Telehealth sessions
Description
Number of Telehealth sessions completed/4
Time Frame
4 weeks
Title
Change in maximum expiratory pressure between pre and post respiratory strength training
Description
A measure of respiratory strength while breathing out
Time Frame
4 weeks
Title
Change in maximum inspiratory pressure between pre and post respiratory strength training
Description
A measure of respiratory strength while breathing in
Time Frame
4 weeks
Title
Change in cough peak expiratory flow between pre and post respiratory strength training
Description
A measure of cough strength
Time Frame
4 weeks
Title
Change in penetration-aspiration scale scores between pre and post respiratory strength training and between before and after surgery
Description
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).
Time Frame
5 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cara Donohue, Ph.D.
Phone
352-273-8632
Email
c.donohue@phhp.ufl.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emily Plowman, Ph.D.
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cardiovascular Clinic and Thoracic/Cardiovascular Surgery at UF Health
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cara Donohue, Ph.D.
Phone
352-273-8632
Email
c.donohue@phhp.ufl.edu
First Name & Middle Initial & Last Name & Degree
Emily Plowman, Ph.D.

12. IPD Sharing Statement

Plan to Share IPD
No

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Respiratory Strength Training in Cardiac Surgical Patients

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