- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06203184
The Effect of Video Game-Based Exercises After Open Heart Surgery
Effect of Video Game-Based Exercises on Respiratory Muscle Strength and Physical Fitness After Open Heart Surgery
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: burcu bağcı
- Phone Number: 5368369804
- Email: ozsert_burcu@hotmail.com
Study Locations
-
-
Şehitkamil
-
Gaziantep, Şehitkamil, Turkey, 27500
- Recruiting
- Sanko University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: video game based exercise training
Breathing Games; developed by a company called &Breathing Labs&; allow breathing exercises to be implemented based on video games.
Studies have reported that breathing exercises accompanied by visual feedback provide additional benefits, and it has been stated that the virtual reality-based approach is an effective method in this respect.
|
Respiratory muscle training and other factors will be examined through 12 weeks of video-based game exercises.
|
|
Other: control group
No intervention will be made to the control group.
|
Respiratory muscle training and other factors will be examined through 12 weeks of video-based game exercises.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
tiredness
Time Frame: 12 weeks
|
Modified Borg Scale
|
12 weeks
|
|
Comorbid disease status
Time Frame: 12 weeks
|
Charlson Comorbidity Index
|
12 weeks
|
|
Hospital Anxiety and Depression
Time Frame: 12 weeks
|
Hospital Hospital Anxiety and Depression Scale
|
12 weeks
|
|
Physical Activity
Time Frame: 12 weeks
|
International Physical Activity Questionnaire-Short Form (IPAQ-SF)
|
12 weeks
|
|
Measures quality of life status
Time Frame: 12 weeks
|
EQ-5D-3l quality of life scale
|
12 weeks
|
|
activity of daily living
Time Frame: 12 weeks
|
KATZ İndex
|
12 weeks
|
|
measures pain intensity
Time Frame: 12 weeks
|
Visual Analog Scale
|
12 weeks
|
|
Sleep Quality
Time Frame: 12 weeks
|
Pittsburg Sleep Quality Index
|
12 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: burcu bağcı, Sanko University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- BurcuB
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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