Acute Responses of Active Video Games and Traditional Exercise Program in in Patients With Pulmonary Hypertension

Pulmonary Hypertension Clinical Trial

Official title:

Comparison of Acute Responses of Active Video Games and Traditional Exercise Program in Patients With Pulmonary Hypertension

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05901168
• Other study ID #: DokuzEU-PAH-001
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: March 2024

Study information

• Verified date: January 2024
• Source: Dokuz Eylul University
• Contact: Ezgi Ceren OZCAN
• Phone: +905532704351
• Email: ezgicerenozcan[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

At least 20 volunteers with a diagnosis of Pulmonary Hypertension in the Department of Cardiology of Dokuz Eylul University and who meet the criteria for follow-up and inclusion will participate in the study. The aim of this study is to examine the acute effects of active video games compared to traditional exercise and the effects on energy expenditure and enjoyment in PD patients. Demographic and clinical information of the participants will be questioned. Active video games and home-based exercise sessions will be held randomly/by the same person with a break of at least 1 day in 1 week, lasting 20 minutes. Heart rate, blood pressure, shortness of breath and oxygen saturation will be measured before and after the sessions. In addition, energy expenditure, heart rate, perceived exertion, shortness of breath and oxygen saturation will be recorded during the sessions. In addition, arterial stiffness will be evaluated with a non-invasive device. At the end of the sessions, whether people like active video games or not will be questioned with a 10-point Likert-type scale.

Description:

Pulmonary hypertension (PH) is a progressive disease that can lead to death as a result of right ventricular overload and right heart failure. Early diagnosis and treatment are important. In cardiac catheterization, it is defined as the measurement of mean pulmonary artery pressure above 20 mmHg. Exercise training in Pulmonary Disease has benefits such as improving endothelial dysfunction, muscle blood supply, peripheral O2 extraction, muscle strength, ventilation efficiency, ventricular contractility, reducing adrenergic tone, increasing vagal modulation, and restoring baroreflex arterial sensitivity. There are studies and meta-analyses that show that exercise programs applied under supervision in addition to optimal medical treatment and tailored to the patient have positive effects on functional capacity and quality of life in all Pulmonary Disease groups. Active video games are reported as a useful method to increase adherence to physical exercise routines. Active video games are defined as: playing video games that require intense physical exercise, for exercise purposes, and in which the participant moves large muscle groups in response to cues. It has been reported that active video games that require physical exertion can improve physical activity. Body movements performed in active video games result in varying levels of intensity and energy expenditure. Studies investigating energy expenditure in various age groups have shown that active video games promote physical activity and increase energy expenditure at levels appropriate for moderate to vigorous physical activity. However, the effect of active video games on energy expenditure, attainment of moderate intensity, and acute responses in individuals with Pulmonary Disease compared to conventional exercise has not been clearly investigated. The aim of this study is to examine the acute effects of active video games compared to traditional exercise and the effects on energy expenditure and enjoyment in Pulmonary Disease patients.

Each patient will complete the exercise training and active video game intervention in random order and different days. Active video games intervention will be carried out with a virtual reality system (XBOX360, Microsoft, USA) consisting of a console and sensor. Active video games; will consist of River Rush, Rally Ball and Reflex Ridge games. Traditional-Based Exercise Intervention will consist of active exercises for the upper extremity (without support), active exercises for the lower extremities and body exercises.upper extremity exercises are shoulder flexion, shoulder abduction, elbow flexion at shoulder 90° flexion. Lower extremity exercises are: ankle-foot movements (ankle pumping exercise) heel raise, knee extension in sitting high, hip-knee flexion while lying supine. Body exercises are: bridging andtrunk rotations in sitting. Before and after the sessions; acute responses, vascular responses and enjoyment will be measured. In addition, energy expenditure will be recorded during the sessions.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 2024
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Have been diagnosed with PH

• Volunteering

• Being clinically stable

• New York Heart Association 1-3 class

• Have not received physiotherapy in the last 6 months

Exclusion Criteria:

• Presence of unstable angina

• Presence of severe neurological, pulmonary and musculoskeletal disease

• The patient's desire to quit the study

• Playing more than 20 minutes of active video games 3 days a week

• Pregnancy

• Having significant and uncompensated visual and auditory deficiencies

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Pulmonary Hypertension

Intervention

Other:
• Active Video Games Intervention
Participants will complete active video games in the same order until they fill 20 minutes after the first 5 minutes of warm-up. In addition, during the change between games (lasting approximately 20 seconds), patients will be instructed by a therapist to perform combined exercises to minimize immobility time. These exercises are: elbow flexion and foot flexion, shoulder flexion and unilateral hip extension, and arm abduction and squat exercises that will prevent the patient from cooling down.
• Traditional Exercise Intervention
Active exercises for the upper extremities (without support): Shoulder flexion, Shoulder abduction, Elbow flexion at shoulder 90° flexion. Active exercises for the lower extremities: Ankle-foot movements (ankle pumping exercise), heel raise, Knee extension in sitting high, Hip-knee flexion while lying supine Body: Bridging, Trunk rotations in sitting These exercises will be done in 1 set of 8-10 repetitions. It will take about 20 minutes.

Locations

Country	Name	City	State
Turkey	Dokuz Eylul University	Izmir	Balcova

Sponsors (1)

Lead Sponsor	Collaborator
Dokuz Eylul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exercise load end heart rate	It will be measured with a pulse oximeter at the end of 20 minutes of exercise loading.	Change from baseline to end of 20 minutes of exercise loading
Primary	Exercise load end blood pressure	It will be measured with a sphygmomanometer at the end of 20 minutes of exercise loading.	Change from baseline to end of 20 minutes of exercise loading
Secondary	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 20 minutes of exercise loading. As the modified borg score of the person increases, the perceived effort will increase.	Change from baseline to end of 20 minutes of exercise loading
Secondary	Exercise load end oxygen saturation	Oxygen saturation will be evaluated by pulse oximetry at the end of 20 minutes of exercise loading.	Change from baseline to end of 20 minutes of exercise loading
Secondary	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 20 minutes of exercise loading after warming up. As the modified borg score of the person increases, the perceived shortness of breath will increase.	Change from baseline to end of 20 minutes of exercise loading
Secondary	Evaluation of energy expenditure	Energy expenditure during active video games and traditional exercise will be evaluated using the activity monitor. The activity monitor will be attached to the upper arm. Its accelerometer measures skin temperature, galvanic skin response and heat flux, as well as energy expenditure during movement.	During exercise intervention, average 20 minutes
Secondary	Evaluation of Arterial stiffness	Arterial stiffness will be measured with a noninvasive method with the help of the SphygmocorXCEL device, which can automatically measure with the cuff. By means of a transducer, the pressure on the brachial artery will be increased (augmentation index) and carotid-femoral pulse wave velocity (pulse wave velocity) measurements will be made over the artery.	Change from baseline to end of 20 minutes of exercise loading