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

NCT ID: NCT04903691

Last Updated: 2023-06-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-15
• Study Completion Date: 2021-09-30

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.

Conditions

Cardiorespiratory; Insufficiency, Due to A Procedure, Long-Term, Cardiac Surgery

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Cardiac Exercise Program

Intervention Type: BEHAVIORAL

Participants who enrolled in cardiac exercise program

Additional controls

5 patients who choose not to enter any organized exercise program.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Cardiac Exercise Program

Participants who enrolled in cardiac exercise program

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Basmah Safdar, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale Church Street Research Unit (CSRU)

New Haven, Connecticut, United States

Countries

United States

Other Identifiers

2000028739

Identifier Type: -

Identifier Source: org_study_id