Effects of Early Telerehabilitation in Coronary Artery Bypass Surgery Patients

NCT ID: NCT06240702

Last Updated: 2024-11-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-20
• Study Completion Date: 2024-11-04

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.

Conditions

Coronary Artery Disease; Cardiac Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Telerehabilitation Group

Patients in the experimental group will be included in the face-to-face Phase I rehabilitation program until discharge and in the Phase II telerehabilitation program and sleep hygiene training for 3 weeks after discharge. Respiratory exercises will be performed as part of the phase I rehabilitation program until the patients are discharged. In addition, active range of motion and mobility exercises in bed, sitting position and standing, increasing distance walking and stair ascent and descent training will be provided. During the sessions, the patient's vital signs and clinical status will be monitored with a finger pulse oximeter and a blood pressure measuring device according to the patient's perceived degree of difficulty (Borg Scale). As part of the Phase II telerehabilitation program, respiratory exercises, calisthenic exercises and gait training will be performed.

Group Type: EXPERIMENTAL

Telerehabilitation Group

Intervention Type: OTHER

Unlike the control group, the experimental group will be given a phase II telerehabilitation program and sleep hygiene training for 3 weeks after discharge. Within the scope of the Phase II telerehabilitation program, breathing exercises and calisthenic exercises will be performed at increasing intensity according to the patient's tolerance, 3 days a week for 3 weeks. In addition, walking training will be continued over increasing distances. In addition, it will be aimed to increase sleep quality by giving a sleep hygiene education brochure to the patients in the experimental group. During the sessions, the vital signs and clinical status of the patients will be monitored according to the severity level determined by the finger pulse oximeter device, digital blood pressure monitor, perceived difficulty level (Borg Scale) and maximum heart rate. In addition, patients will be kept in a diary to monitor their compliance with the treatment program.

Control Group

Patients in the control group will be included in the face-to-face Phase I rehabilitation program until discharge and no intervention will be made after discharge. Until the patients in the control group are discharged, respiratory exercises will be performed as in the experimental group within the scope of the phase I rehabilitation program. In addition, active range of motion and mobility exercises in bed, sitting position and standing, increasing distance walking and stair ascent and descent training will be provided. During the sessions, the patient's vital signs and clinical status will be monitored with a finger pulse oximeter and a blood pressure measuring device according to the patient's perceived degree of difficulty (Borg Scale).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Telerehabilitation Group

Unlike the control group, the experimental group will be given a phase II telerehabilitation program and sleep hygiene training for 3 weeks after discharge. Within the scope of the Phase II telerehabilitation program, breathing exercises and calisthenic exercises will be performed at increasing intensity according to the patient's tolerance, 3 days a week for 3 weeks. In addition, walking training will be continued over increasing distances. In addition, it will be aimed to increase sleep quality by giving a sleep hygiene education brochure to the patients in the experimental group. During the sessions, the vital signs and clinical status of the patients will be monitored according to the severity level determined by the finger pulse oximeter device, digital blood pressure monitor, perceived difficulty level (Borg Scale) and maximum heart rate. In addition, patients will be kept in a diary to monitor their compliance with the treatment program.

Intervention Type: OTHER

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)

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Necmettin Erbakan University

OTHER

Sponsor Role: lead

Responsible Party

Muammer Corum

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hanife Dogan, Assoc. Prof.

Role: STUDY_DIRECTOR

Necmettin Erbakan University Faculty Member

Locations

Necmettin Erbakan University Faculty of Medicine

Konya, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

NEU-SSHMYO-FP-MC-01

Identifier Type: -

Identifier Source: org_study_id