Skip to main content
Clinical Trials/NCT06240702
NCT06240702
Completed
Not Applicable

The Effect of Early Cardiopulmonary Telerehabilitation on Exercise Capacity, Cardiac Function, Quality of Life and Emotional Status in Coronary Bypass Surgery Patients

Necmettin Erbakan University1 site in 1 country40 target enrollmentApril 20, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Coronary Artery Disease
Sponsor
Necmettin Erbakan University
Enrollment
40
Locations
1
Primary Endpoint
6 minute walk test (6MWT)
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 20, 2024
End Date
November 4, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Muammer Corum

Lecturer

Necmettin Erbakan University

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)

Outcomes

Primary Outcomes

6 minute walk test (6MWT)

Time Frame: four weeks

The test is performed in a closed area, on a flat surface 30 meters long (every 3 meters is marked), under the supervision of a physiotherapist. Dyspnea and fatigue of the patients are questioned during the 6MWT and the values before and after the test are recorded. At the end of 6 minutes, the total distance walked by the patient is recorded in meters. Studies have shown that a 6-minute walking distance of less than 350 meters is a predictor of mortality in cardiopulmonary diseases.

Duke Activity Status Scale

Time Frame: four weeks

This 12-question index helps to calculate the metabolic equivalent of task (MET) used in daily life. 1 MET represents the resting Oxygen consumption of a 40-year-old 70 kg person at rest, which is normally 3.5 ml/kg/min. According to this index; self-care, eating, dressing, going to the toilet, short walks inside the house, short walks outside, light housework, between 1-4 METs; climbing hills or stairs, fast walking, short jogging, heavier work at home, light sports, between 4-10 METs; Heavy sports such as swimming, tennis are evaluated above 10 METs. The approximate values obtained according to the answers to the questions asked are classified as follows; Excellent if \>7 MET 4-7 MET is Moderate \<4 MET indicates a poor or uncertain prognosis.

State Trait Anxiety Inventory

Time Frame: four weeks

The Turkish version of the State Trait Anxiety Inventory (STAI) will be used to assess the anxiety level of the subjects. The STAI consists of 2 parts, the state anxiety scale and the trait anxiety scale, and a total of 40 questions. When answering the state anxiety scale, patients are asked to select one of the options 'not at all', 'a little', 'a lot' and 'completely' according to the severity of the feelings, thoughts and behaviors expressed by the items; when answering the trait anxiety scale, patients are asked to mark one of the options 'almost never', 'sometimes', 'most of the time' and 'almost always' according to the frequency of the feelings, thoughts and behaviors expressed by the items. High scores indicate a high level of anxiety. Turkish validity and reliability studies have been conducted.

Pittsburgh Sleep Quality Index (PSQI)

Time Frame: four weeks

PSQI was adapted into Turkish by Agargun et al. (1996). PSQI evaluates sleep quality in the last month. 19 of the total 24 questions included in PSQI are self-report questions. 5 questions are answered by the spouse or a roommate. The last 5 questions mentioned are used only for clinical information and are not included in the scoring. The 18 items included in the scoring are grouped into 7 component scores. Some of the components are specified with a single item, while others are obtained by grouping several items. Each item is evaluated on a scale of 0-3 points. The sum of the 7 component scores gives the total PSQI score. The total score has a value between 0-21. A high total score indicates poor sleep quality.

Secondary Outcomes

  • Minnesota Living With Heart Failure Questionnaire(four weeks)
  • Modified Medical Research Council Dyspnea Scale(four weeks)
  • Body Mass Index(four weeks)
  • Body Weight(four weeks)
  • Body height(four weeks)
  • Respiratory Frequency(four weeks)
  • Left Ventricular Dysfunction Scale (LVD-36)(four weeks)
  • Echocardiography(four weeks)
  • Hand Grip Strength Assessment(four weeks)
  • 30-second sit-to-stand test(four weeks)
  • Oxygen Saturation(four weeks)
  • Heart Rate(four weeks)
  • Blood Pressure(four weeks)

Study Sites (1)

Loading locations...

Similar Trials