NCT05722366

Brief Summary

At least 25 volunteers with a diagnosis of coronary artery disease in the Department of Cardiology of Dokuz Eylul University and who meet the criteria for follow-up and inclusion will participate in the study. Demographic and clinical information of the participants will be questioned. Active video games and exercise sessions will be randomized to last 25 minutes. Before and after the sessions, heart rate, blood pressure, shortness of breath, oxygen saturation and arterial stiffness will be measured. In addition, energy expenditure, heart rate, perceived exertion, shortness of breath and oxygen saturation will be recorded during the sessions. At the end of the sessions, the person will be asked if they enjoy active video games.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for not_applicable coronary-artery-disease

Timeline
Completed

Started Nov 2022

Shorter than P25 for not_applicable coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
completed

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

November 20, 2022

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

December 19, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 10, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 14, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

September 8, 2023

Status Verified

September 1, 2023

Enrollment Period

5 months

First QC Date

December 19, 2022

Last Update Submit

September 6, 2023

Conditions

Keywords

coronary artery diseaseactive video gamesaerobic exercise

Outcome Measures

Primary Outcomes (5)

  • Exercise load end heart rate

    It will be measured with a pulse oximeter at the end of 15 minutes of exercise loading after warming up.

    At the 15th minute of the exercise after the warm-up.

  • Exercise load end blood pressure

    It will be measured with a sphygmomanometer at the end of 15 minutes of exercise loading after warming up.

    At the 15th minute of the exercise after the warm-up.

  • Exercise load end perceived effort

    The degree of perceived effort will be evaluated with the modified borg scale (M.Borg 0-10)at the end of 15 minutes of exercise loading after warming up. As the modified borg score of the person increases, the perceived effort will increase.

    At the 15th minute of the exercise after the warm-up.

  • Exercise load end oxygen saturation

    Oxygen saturation will be evaluated by pulse oximetry at the end of 15 minutes of exercise loading after warming up.

    At the 15th minute of the exercise after the warm-up.

  • Exercise load end shortness of breath

    Shortness of breath will be assessed with the modified borg scale(M.Borg 0-10) at the end of 15 minutes of exercise loading after warming up.As the modified borg score of the person increases, the perceived shortness of breath will increase.

    At the 15th minute of the exercise after the warm-up.

Secondary Outcomes (19)

  • Evaluation of energy expenditure

    ''During exercise intervention, average 25 minutes''

  • Evaluation of Arterial stiffness

    Before interventions

  • Evaluation of Arterial stiffness

    ''First minutes'' after the intervention

  • Baseline Blood pressure

    Before interventions

  • End of intervention blood pressure

    Within the first minutes after the intervention

  • +14 more secondary outcomes

Study Arms (2)

Active Video Game İntervention

ACTIVE COMPARATOR

The active video games intervention will be carried out with a virtual reality system (XBOX360, Microsoft, USA) consisting of a console and a sensor. Active video games consist of Bowling, River Rush, Rally Ball and Reflex Ridge games. Participants will exercise for a total of 25 minutes with light-paced games for warm-up for the first 5 minutes, then brisk games with different body movements until the 15 minutes are complete, and light-paced games for 5 minutes to cool down. Participants will complete active video games in the same order.

Other: Active video game

Aerobic Exercise Intervention

ACTIVE COMPARATOR

The exercise intervention will consist of a continuous moderate intensity walking session on the treadmill. After the first 5 minutes of warm-up,a at 55-70% of the peak heart rate reserve(HRR)with a 15-minute walking session, and 5 minutes of cooling down total of 25 minutes of exercise will be performed.

Other: aerobic exercise

Interventions

With the closed envelope method, the order in which the participants will perform active video games and aerobic exercise will be determined. It will be applied with 2 weeks between interventions.

Active Video Game İntervention

With the closed envelope method, the order in which the participants will perform active video games and aerobic exercise will be determined. It will be applied with 2 weeks between interventions.

Aerobic Exercise Intervention

Eligibility Criteria

Age40 Years - 75 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Having been diagnosed with coronary artery disease
  • Being clinically stable
  • Becoming a volunteer

You may not qualify if:

  • The presence of unstable angina
  • The presence of a pacemaker
  • The presence of cardiomyopathy
  • The presence of a high cardiovascular risk
  • The presence of November severe neurological, pulmonary and musculoskeletal system diseases
  • The patient wants to quit the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dokuz Eylül University

Izmir, Balcova, 35140, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Exercise

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 19, 2022

First Posted

February 10, 2023

Study Start

November 20, 2022

Primary Completion

April 14, 2023

Study Completion

August 1, 2023

Last Updated

September 8, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations