Clinical trial NCT06240702: Effects of Early Telerehabilitation in Coronary Artery Bypass Surgery Patients
Official title: The Effect of Early Cardiopulmonary Telerehabilitation on Exercise Capacity, Cardiac Function, Quality of Life and Emotional Status in Coronary Bypass Surgery Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Cardiac Disease
Keywords: Coronary Artery Bypass
Cardiac Rehabilitation
Sleep Hygiene
Telerehabilitation
Exercise
Lead sponsor: Necmettin Erbakan University
Sponsor class: OTHER
First posted: 2024-02-05
Enrollment: 40
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: It is a randomized controlled clinical trial with 2 groups, experimental and control. The experimental group will be treated with telerehabilitation while the control group will not.
Primary purpose: TREATMENT

Brief summary: The aim of this study was to investigate the effects of phase I and early phase II rehabilitation with telerehabilitation method and sleep hygiene training on physical capacity, cardiac functions, anxiety level, quality of life and sleep quality in patients undergoing coronary artery bypass graft surgery.

Detailed description: Coronary artery disease is one of the most important diseases affecting quality of life in recent years. Coronary artery bypass graft surgery (CABGC), one of the methods used in the treatment of this disease, is widely accepted as a common operation. However, both the surgical intervention and the cardiac and pulmonary complications caused by coronary artery disease, such as decreased physical capacity, decreased quality of life and sleep quality, and restriction in functional activities make it difficult to return to pre-disease level. Today, it is a scientific fact that cardiac and pulmonary rehabilitation applied at the earliest period following surgical treatment reduces the risk of mortality and morbidity, prevents complications and facilitates return to daily life. In fact, it is now a necessity to evaluate and treat patients comprehensively in many aspects such as nutrition, sleep quality and psychological status with a holistic approach. Today, applications that bring together healthcare personnel and patients in a virtual environment such as telemedicine, telerehabilitation and mobile-health, which have been widely used in different medical and health fields, especially after the coronavirus-19 pandemic, have gained importance. Telerehabilitation has advantages in different fields such as neurological, orthopedic, cardiac and pulmonary rehabilitation, such as the ability of the physiotherapist to follow the patient remotely, to apply the rehabilitation program, and to be accessible at any time. In addition, it is stated in the literature that it has mitigating effects on the patient's dependency and health costs, such as eliminating the need for the patient to travel to the center and reducing the need for caregivers. When the literature is examined, it is seen that there are few cardiac and pulmonary rehabilitation applied with telerehabilitation method in the postoperative period in coronary artery bypass graft surgery patients. In addition, there is no study in the literature examining the effect of sleep hygiene training in addition to telerehabilitation on these patients. Therefore, this study aimed to contribute to the literature as an original study by examining the effects of cardiopulmonary rehabilitation and sleep hygiene training applied for 4 weeks with the telerehabilitation method, which is a current approach, on patients who underwent coronary artery bypass graft surgery.

Eligibility criteria: Inclusion Criteria:

* Participants who are class 2-3 according to the New York Heart Association (NYHA)
* Participants had an ejection fraction \>40%
* If the participant has had a myocardial infarction (MI), 7 days have passed since the MI
* Low-medium risk group patients as a result of Euroscore evaluation (0-2 low risk, 3-5 medium risk, 6\< high)
* Patients with adequate cognition-perception level (Mini mental test score of 24 and above)
* Individuals who are not diagnosed with sleep disorders for any reason
* Having the knowledge to make video calls with a smart phone
* Declaring that you wish to participate in the study with written consent

Exclusion Criteria:

* Aneurysm history
* Patients with advanced left ventricular dyskinesia
* Patients with neurological orthopedic comorbid diseases
* Presence of any defect in the rib cage
* Patients with Chronic Obstructive Pulmonary Disease (COPD)
* Patients hospitalized for a long time (6 months and more)

Primary outcomes:
measure: 6 minute walk test (6MWT)
timeFrame: four weeks
measure: Duke Activity Status Scale
timeFrame: four weeks
measure: State Trait Anxiety Inventory
timeFrame: four weeks
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: four weeks
Secondary outcomes:
measure: Echocardiography
timeFrame: four weeks
measure: Left Ventricular Dysfunction Scale (LVD-36)
timeFrame: four weeks
measure: Minnesota Living With Heart Failure Questionnaire
timeFrame: four weeks
measure: Modified Medical Research Council Dyspnea Scale
timeFrame: four weeks
measure: Hand Grip Strength Assessment
timeFrame: four weeks
measure: 30-second sit-to-stand test
timeFrame: four weeks
measure: Body Weight
timeFrame: four weeks
measure: Body height
timeFrame: four weeks
measure: Body Mass Index
timeFrame: four weeks
measure: Heart Rate
timeFrame: four weeks
measure: Blood Pressure
timeFrame: four weeks
measure: Respiratory Frequency
timeFrame: four weeks
measure: Oxygen Saturation
timeFrame: four weeks
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Necmettin Erbakan University Faculty of Medicine
Study officials:
affiliation: Necmettin Erbakan University Faculty Member
name: Hanife Dogan, Assoc. Prof.
role: STUDY_DIRECTOR
References: