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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06203184
Other study ID # BurcuB
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 11, 2023
Est. completion date June 1, 2024

Study information

Verified date January 2024
Source Sanko University
Contact burcu bagci
Phone 5368369804
Email ozsert_burcu@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of the study is to investigate the effects of video game-based exercises applied in addition to the cardiac rehabilitation program applied after open heart surgery, on pulmonary function and functional independence in the acute state. After ethics committee approval is received; Patients who volunteer to participate in the study will be divided into two groups by simple random method. The first group will be given a 12-week cardiac rehabilitation program after bypass surgery, and the second group will be given video game-based exercise training together with the cardiac rehabilitation program for 12 weeks. It is planned to apply the cardiac rehabilitation program to both groups twice a day during the postoperative period until hospital discharge. The patient's cardiac rehabilitation program after hospital discharge will be carried out in the cardiac rehabilitation unit three days a week. Cardiac r in the video game-based exercise group In addition to rehabilitation; "Breathing Labs Breathing Games" exercises will continue during the hospital stay, and Xbox games will continue after discharge. Evaluations will be made in the preoperative period (within one week before surgery) and at the end of the 12th postoperative week.


Description:

Our work; In order to evaluate the effect of video game-based exercises on respiratory muscle strength and physical fitness within the scope of cardiac rehabilitation after open heart surgery; It will be conducted with patients who have undergone open bypass surgery in the Cardiovascular Surgery Department of Private Sani Konukoğlu Training and Research Hospital. After ethics committee approval is received; Patients who volunteer to participate in the study will be divided into two groups by simple random method. The first group will be given a 12-week cardiac rehabilitation program after bypass surgery, and the second group will be given video game-based exercise training together with the cardiac rehabilitation program for 12 weeks. It is planned to apply the cardiac rehabilitation program to both groups twice a day during the postoperative period until hospital discharge. The patient's cardiac rehabilitation program after hospital discharge will be carried out in the cardiac rehabilitation unit three days a week. Cardiac in the video game-based exercise group In addition to rehabilitation; "Breathing Labs Breathing Games" exercises will continue during the hospital stay, and Xbox games will continue after discharge. Evaluations will be made in the preoperative period (within one week before surgery) and at the end of the 12th postoperative week. Maximum inspiratory pressure (MIP), maximal expiratory pressure (MEP) with an intraoral pressure measurement device to evaluate the respiratory muscle strength of the patients, Respiratory Function Test to evaluate respiratory function, Sensior Fitness Test to evaluate physical fitness. International Physical Activity Questionnaire - Short Form (IPAQ-SF) to determine the physical activity levels of the cases in daily life, Charlson Comorbidity Index to quantitatively examine the comorbidities that have an impact on prognosis, and to measure the severity of anxiety and depression in cases with physical diseases. Hospital Anxiety and Depression Scale to monitor patients; quality of life and changes, EQ-5D scale to evaluate patients; quality of life, KATZ scale to evaluate independence in daily living activities, Visual Analog Scale to evaluate dyspnea and pain symptoms. , the Pittsburg Sleep Quality Index will be used to evaluate sleep quality, and the Modified Borg Scale will be used to determine exercise intensity.


Recruitment information / eligibility

Status Recruiting
Enrollment 28
Est. completion date June 1, 2024
Est. primary completion date February 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Those who are younger than 65 years old - Having undergone open heart surgery - Hemodynamically stable - At ambulatory level - Agreeing to participate in the study - Scoring 25 or more from the Mini-Mental Test Exclusion Criteria: - • Those diagnosed with previous cerebrovascular accident - Those with orthopedic problems that prevent walking - Those with uncontrolled diabetes - Those with uncontrolled hypertension - Those with severe vision problems - Having other diseases (pulmonary, neurological, metabolic, etc.) that limit participation in exercise training. - Having verbal and/or auditory cooperation problems

Study Design


Related Conditions & MeSH terms


Intervention

Other:
video based exercises
Respiratory muscle training and other factors will be examined through 12 weeks of video-based game exercises.

Locations

Country Name City State
Turkey Sanko University Gaziantep Sehitkamil

Sponsors (1)

Lead Sponsor Collaborator
Sanko University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary tiredness Modified Borg Scale 12 weeks
Primary Comorbid disease status Charlson Comorbidity Index 12 weeks
Primary Hospital Anxiety and Depression Hospital Hospital Anxiety and Depression Scale 12 weeks
Primary Physical Activity International Physical Activity Questionnaire-Short Form (IPAQ-SF) 12 weeks
Primary Measures quality of life status EQ-5D-3l quality of life scale 12 weeks
Primary activity of daily living KATZ Index 12 weeks
Primary measures pain intensity Visual Analog Scale 12 weeks
Primary Sleep Quality Pittsburg Sleep Quality Index 12 weeks
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