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Clinical Trials/NCT04903691
NCT04903691
Completed
Not Applicable

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

Yale University1 site in 1 country9 target enrollmentMay 15, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiorespiratory; Insufficiency, Due to A Procedure, Long-Term, Cardiac Surgery
Sponsor
Yale University
Enrollment
9
Locations
1
Primary Endpoint
Change in functional fitness.
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
May 15, 2021
End Date
September 30, 2021
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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)

Outcomes

Primary Outcomes

Change in functional fitness.

Time Frame: Baseline and 2 weeks after completing exercise program

Change in functional fitness as measured by the Short Physical Performance Battery (higher overall score or less time to completion indicates higher fitness)

Change in cardiorespiratory fitness

Time Frame: Baseline and 2 weeks after completing exercise program

Change in peak cardiorespiratory fitness as measured by metabolic equivalent (METS). (Higher values indicate higher fitness)

Change in strength

Time Frame: Baseline and 2 weeks after completing exercise program

Change in strength as measured by grip strength (Higher values indicate better strength).

Change in cognition

Time Frame: Baseline and 2 weeks after completing exercise program

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)

Study Sites (1)

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