NCT06203184

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 11, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 2, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 12, 2024

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

January 12, 2024

Status Verified

January 1, 2024

Enrollment Period

5 months

First QC Date

January 2, 2024

Last Update Submit

January 2, 2024

Conditions

Keywords

sleep qualitypyhscal fitnessOpen Heart Surgerrespiratory muscle strenght

Outcome Measures

Primary Outcomes (8)

  • tiredness

    Modified Borg Scale

    12 weeks

  • Comorbid disease status

    Charlson Comorbidity Index

    12 weeks

  • Hospital Anxiety and Depression

    Hospital Hospital Anxiety and Depression Scale

    12 weeks

  • Physical Activity

    International Physical Activity Questionnaire-Short Form (IPAQ-SF)

    12 weeks

  • Measures quality of life status

    EQ-5D-3l quality of life scale

    12 weeks

  • activity of daily living

    KATZ İndex

    12 weeks

  • measures pain intensity

    Visual Analog Scale

    12 weeks

  • Sleep Quality

    Pittsburg Sleep Quality Index

    12 weeks

Study Arms (2)

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.

Other: video based exercises

control group

OTHER

No intervention will be made to the control group.

Other: video based exercises

Interventions

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

control groupvideo game based exercise training

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanko University

Gaziantep, Şehitkamil, 27500, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • burcu bağcı

    Sanko University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

January 2, 2024

First Posted

January 12, 2024

Study Start

September 11, 2023

Primary Completion

February 1, 2024

Study Completion

June 1, 2024

Last Updated

January 12, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations