Clinical trial NCT04903691: Changes in Fitness and Strength in Postoperative Cardiac Patients Undergoing Exercise Therapy: Biological and Functional Mechanisms of Recovery
Official title: Changes in Fitness and Strength in Postoperative Cardiac Patients Undergoing Exercise Therapy: Biological and Functional Mechanisms of Recovery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiorespiratory; Insufficiency, Due to A Procedure, Long-Term, Cardiac Surgery
Keywords: cardiorespiratory fitness
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2021-05-26
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention study with organized exercise program in intervention arm, no organized exercise in control arm
Primary purpose: SUPPORTIVE_CARE

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.

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)

Primary outcomes:
measure: Change in cardiorespiratory fitness
timeFrame: Baseline and 2 weeks after completing exercise program
measure: Change in strength
timeFrame: Baseline and 2 weeks after completing exercise program
measure: Change in functional fitness.
timeFrame: Baseline and 2 weeks after completing exercise program
measure: Change in cognition
timeFrame: Baseline and 2 weeks after completing exercise program
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale Church Street Research Unit (CSRU)
state: Connecticut
Study officials:
affiliation: Yale University
name: Basmah Safdar, MD
role: PRINCIPAL_INVESTIGATOR
References: