Effects of Early Telerehabilitation in Coronary Artery Bypass Surgery Patients

NCT06240702 | Completed

• 1 other identifier: NEU-SSHMYO-FP-MC-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease; Cardiac Disease

Keywords

Coronary Artery Bypass; Cardiac Rehabilitation; Sleep Hygiene; Telerehabilitation; Exercise

Outcome Measures

Primary Outcomes (4)

• 6 minute walk test (6MWT)

  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.

  four weeks

• Duke Activity Status Scale

  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.

  four weeks

• State Trait Anxiety Inventory

  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.

  four weeks

• Pittsburgh Sleep Quality Index (PSQI)

  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.

  four weeks

Secondary Outcomes (13)

• Echocardiography

  four weeks

• Left Ventricular Dysfunction Scale (LVD-36)

  four weeks

• Minnesota Living With Heart Failure Questionnaire

  four weeks

• Modified Medical Research Council Dyspnea Scale

  four weeks

• Hand Grip Strength Assessment

  four weeks

Study Arms (2)

Telerehabilitation Group

EXPERIMENTAL

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.

Other: Telerehabilitation Group

Control Group

NO INTERVENTION

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).

Interventions

Telerehabilitation Group 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.

Telerehabilitation Group

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Necmettin Erbakan University: lead

Study Sites (1)

Necmettin Erbakan University Faculty of Medicine

Konya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Coronary Artery Disease; Heart Diseases; Sleep Hygiene; Motor Activity

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Health Behavior; Behavior

Study Officials

• Hanife Dogan, Assoc. Prof.

  Necmettin Erbakan University Faculty Member

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: 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.

Study Record Dates

• First Submitted: January 26, 2024
• First Posted: February 5, 2024
• Study Start: April 20, 2024
• Primary Completion: August 20, 2024
• Study Completion: November 4, 2024
• Last Updated: November 12, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)