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OpenTrials
Completed

NCT Number: NCT04903691

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale Church Street Research Unit (CSRU)

New Haven, Connecticut, 06511, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Cardiac Exercise Program

Behavioral

Participants who enrolled in cardiac exercise program

Primary outcomes

  1. 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)

  2. 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).

  3. 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)

  4. 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)

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
May 26, 2021
Registry last updated
Jun 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.