Changes in Fitness and Strength in Postoperative Cardiac Patients Undergoing Exercise Therapy: Biological and Functional Mechanisms of Recovery

This study seeks to determine the biological, physiological and psychological effects of supervised exercise programs in patients surviving open heart surgery.

Study Overview

• Status: Completed
• Conditions: Cardiorespiratory; Insufficiency, Due to A Procedure, Long-Term, Cardiac Surgery
• Intervention / Treatment: Behavioral: Cardiac Exercise Program

Detailed Description

Patients who have survived open heart surgery and cleared for exercise by their clinical team will be approached to enter a 12-week exercise program. Patient will consent to train with a personalized program either in strength, functional or aerobic exercise in a supervised setting for 3 sessions per week for a minimum of 12-week period. The aim is to enroll males and females in this arm in 1:1 ratio if possible. A separate cohort of patients entering cardiac rehabilitation (CR) will also be included for comparison. The CR program includes three sessions per week for a maximum of 36 sessions. The enrollment and retention rates in CR will be monitored. In this study, five patients who have undergone cardiac surgery and chosen not to participate in organized exercise program will be included. Participants cardiorespiratory fitness will be measured either using a questionnaire or in person. Through each phase of the study, the change in fitness, strength, biomarkers, body composition, cognition and psychosocial recovery will be monitored. All subjects will undergo detailed assessments in the research lab 2 weeks before and after finishing or exiting exercise program. A short (3-month) and long term (12-month) outcomes including rates of survival, major adverse cardiac events, cognition and cardiac-related hospitalizations will be collected as well during the study.

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • Yale Church Street Research Unit (CSRU)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

- Patients at least 18 years of age or older who undergo open heart surgery and who intend to enroll in a cardiac rehabilitation program.

Exclusion Criteria:

• Patients may be excluded for inability to read or understand English
• suffering from a condition that precludes informed consent (for example, cardiogenic shock)
• hemodynamic instability
• ongoing trauma or substance overdoses
• known intellectual or developmental delay
• communication impairment
• active users of illicit substances
• active psychiatric illness
• inability to attend cardiac rehabilitation (homeless, in police custody, or living out of state)
• inability to exercise (lower limb amputation, bedridden, decompensated heart failure, ongoing cancer treatment)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise training; 130 patients who underwent open heart surgery and are cleared for exercise.These will include patients who enter supervised cardiac rehabilitation as well as patients who enter a supervised exercise program focusing strength training, endurance of functional training.	Behavioral: Cardiac Exercise Program; Participants who enrolled in cardiac exercise program
No Intervention: Additional controls; 5 patients who choose not to enter any organized exercise program.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in cardiorespiratory fitness	Change in peak cardiorespiratory fitness as measured by metabolic equivalent (METS). (Higher values indicate higher fitness)	Baseline and 2 weeks after completing exercise program
Change in strength	Change in strength as measured by grip strength (Higher values indicate better strength).	Baseline and 2 weeks after completing exercise program
Change in functional fitness.	Change in functional fitness as measured by the Short Physical Performance Battery (higher overall score or less time to completion indicates higher fitness)	Baseline and 2 weeks after completing exercise program
Change in cognition	Measured by standardized tests of cognition such as Montreal Cognitive Assessment (MoCA) (Higher values indicate better cognition with scores less than 23-26 adjusting for education indicative of impaired cognition)	Baseline and 2 weeks after completing exercise program

Collaborators and Investigators

• Sponsor: Yale University
• Investigators: Principal Investigator: Basmah Safdar, MD, Yale University

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2021
• Primary Completion (Actual): September 30, 2021
• Study Completion (Actual): September 30, 2021

Study Registration Dates

• First Submitted: May 21, 2021
• First Submitted That Met QC Criteria: May 21, 2021
• First Posted (Actual): May 26, 2021

Study Record Updates

• Last Update Posted (Actual): June 9, 2023
• Last Update Submitted That Met QC Criteria: June 7, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: cardiorespiratory fitness
• Other Study ID Numbers: 2000028739

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No