Respiratory Strength Training in Cardiac Surgical Patients

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04887415
• Other study ID #: IRB202100993
• Secondary ID: OCR40654
• Status: Recruiting
• Phase: N/A
• Start date: September 2, 2021
• Est. completion date: February 2023

Study information

• Verified date: January 2022
• Source: University of Florida
• Contact: Cara Donohue, Ph.D.
• Phone: 352-273-8632
• Email: c.donohue[@]phhp.ufl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: February 2023
• Est. primary completion date: October 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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).

Locations

Country	Name	City	State
United States	Cardiovascular Clinic and Thoracic/Cardiovascular Surgery at UF Health	Gainesville	Florida

Sponsors (3)

Lead Sponsor	Collaborator
University of Florida	American Heart Association, American Speech Language Hearing Foundation (ASHFoundation)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence to respiratory strength training	Number of respiratory strength training repetitions/1000	4 weeks
Primary	Attendance at Telehealth sessions	Number of Telehealth sessions completed/4	4 weeks
Primary	Change in maximum expiratory pressure between pre and post respiratory strength training	A measure of respiratory strength while breathing out	4 weeks
Primary	Change in maximum inspiratory pressure between pre and post respiratory strength training	A measure of respiratory strength while breathing in	4 weeks
Primary	Change in cough peak expiratory flow between pre and post respiratory strength training	A measure of cough strength	4 weeks
Primary	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).	5 weeks