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

Not Applicable

Completed

• Conditions: Cardiorespiratory; Insufficiency, Due to A Procedure, Long-Term, Cardiac Surgery
• Interventions: Behavioral: Cardiac Exercise Program

• Registration Number: NCT04903691
• Lead Sponsor: Yale University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2021-05-15
• Study First Submitted: 2021-05-21
• Study First Submitted QC: 2021-05-21
• Study First Posted: 2021-05-26
• Primary Completion: 2021-09-30
• Study Completion: 2021-09-30
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-07
• Last Update Posted: 2023-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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.

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise training	Cardiac Exercise Program	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.

Primary Outcome Measures

Name	Time	Method
Change in functional fitness.	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	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	Baseline and 2 weeks after completing exercise program	Change in strength as measured by grip strength (Higher values indicate better strength).
Change in cognition	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)

Trial Locations

Locations (1)

Yale Church Street Research Unit (CSRU); 🇺🇸 New Haven, Connecticut, United States