Clinical trial NCT05901168: Acute Responses of Active Video Games and Traditional Exercise Program in in Patients With Pulmonary Hypertension
Official title: Comparison of Acute Responses of Active Video Games and Traditional Exercise Program in Patients With Pulmonary Hypertension
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pulmonary Hypertension
Keywords: pulmonary hypertension
active video games
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
First posted: 2023-06-13
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Exercise load end heart rate
timeFrame: Change from baseline to end of 20 minutes of exercise loading
measure: Exercise load end blood pressure
timeFrame: Change from baseline to end of 20 minutes of exercise loading
Secondary outcomes:
measure: Exercise load end perceived effort
timeFrame: Change from baseline to end of 20 minutes of exercise loading
measure: Exercise load end oxygen saturation
timeFrame: Change from baseline to end of 20 minutes of exercise loading
measure: Exercise load end shortness of breath
timeFrame: Change from baseline to end of 20 minutes of exercise loading
measure: Evaluation of energy expenditure
timeFrame: During exercise intervention, average 20 minutes
measure: Evaluation of Arterial stiffness
timeFrame: Change from baseline to end of 20 minutes of exercise loading
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Dokuz Eylul University
state: Balcova
Study officials:
References: