Open Heart SurgeryNCT06203184
The Effect of Video Game-Based Exercises After Open Heart Surgery
A study testing video based exercises in people with Open Heart Surgery and Physical Fitness, run by Sanko University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Open Heart Surgery, Physical Fitness, Sleep Quality
- What is being tested?
- video based exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Sep 2023to 1 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- • 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Sanko University
Gaziantep, Şehitkamil, 27500
About this study
Official title: 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.
Read the 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.
- Conditions
- Open Heart Surgery, Physical Fitness, Sleep Quality
- Being tested
- video based exercises
- Keywords
- sleep quality, pyhscal fitness, Open Heart Surger, respiratory muscle strenght
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
video based exercisesOther
Respiratory muscle training and other factors will be examined through 12 weeks of video-based game exercises.
| Study group | Role | What they receive |
|---|---|---|
| video game based exercise training | Experimental | 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. Receives: Other: video based exercises |
| control group | Other | No intervention will be made to the control group. Receives: Other: video based exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
tiredness
Modified Borg Scale
Measured: 12 weeks
Comorbid disease status
Charlson Comorbidity Index
Measured: 12 weeks
Hospital Anxiety and Depression
Hospital Hospital Anxiety and Depression Scale
Measured: 12 weeks
Physical Activity
International Physical Activity Questionnaire-Short Form (IPAQ-SF)
Measured: 12 weeks
Measures quality of life status
EQ-5D-3l quality of life scale
Measured: 12 weeks
activity of daily living
KATZ İndex
Measured: 12 weeks
measures pain intensity
Visual Analog Scale
Measured: 12 weeks
Sleep Quality
Pittsburg Sleep Quality Index
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study start11 Sep 2023
- Primary completion1 Feb 2024 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Open Heart SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanko University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burcu Bağcı, Sanko University
- Investigators
- burcu bağcı, Principal investigator, Sanko University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06203184
- Sponsor's protocol ID
- BurcuB
- Status last verified
- Jan 2024
- First submitted
- 2 Jan 2024
- Last updated
- 12 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Video Game-Based Exercises on Respiratory Muscle Strength and Physical Fitness After Open Heart Surgery
- ClinicalTrials.gov ID
- NCT06203184
- Acronym / sponsor ID
- BurcuB
- Conditions
- Open Heart Surgery, Physical Fitness, Sleep Quality
- Keywords
- sleep quality, pyhscal fitness, Open Heart Surger, respiratory muscle strenght
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Sanko UniversityUniversity, hospital or other
- Study start
- 11 Sep 2023 (actual)
- Primary completion
- 1 Feb 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 12 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| video game based exercise training | Experimental | Other: video based exercisesBreathing 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. |
| control group | Other | Other: video based exercisesNo intervention will be made to the control group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Those who are younger than 65 years old
Key exclusion criteria (7 listed)
- • Those diagnosed with previous cerebrovascular accident
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| video based exercisesRespiratory muscle training and other factors will be examined through 12 weeks of video-based game exercises. | Other | control group, video game based exercise training |
Primary outcome
tiredness
Time frame: 12 weeks
Modified Borg Scale
Comorbid disease status
Time frame: 12 weeks
Charlson Comorbidity Index
Hospital Anxiety and Depression
Time frame: 12 weeks
Hospital Hospital Anxiety and Depression Scale
Physical Activity
Time frame: 12 weeks
International Physical Activity Questionnaire-Short Form (IPAQ-SF)
Measures quality of life status
Time frame: 12 weeks
EQ-5D-3l quality of life scale
activity of daily living
Time frame: 12 weeks
KATZ İndex
measures pain intensity
Time frame: 12 weeks
Visual Analog Scale
Sleep Quality
Time frame: 12 weeks
Pittsburg Sleep Quality Index
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
burcu bağcı principal investigator
Sanko University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing video based exercises in people with Open Heart Surgery and Physical Fitness, run by Sanko University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact burcu bağcı (5368369804, ozsert_burcu@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
tiredness (time frame: 12 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2024.