NCT05901168

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 PH 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2023

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 3, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 13, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2024

Completed
Last Updated

January 2, 2026

Status Verified

December 1, 2025

Enrollment Period

9 months

First QC Date

May 3, 2023

Last Update Submit

December 29, 2025

Conditions

Keywords

pulmonary hypertensionactive video games

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (5)

  • Exercise load end perceived effort

    Change from baseline to end of 20 minutes of exercise loading

  • Exercise load end oxygen saturation

    Change from baseline to end of 20 minutes of exercise loading

  • Exercise load end shortness of breath

    Change from baseline to end of 20 minutes of exercise loading

  • Evaluation of energy expenditure

    During exercise intervention, average 20 minutes

  • Evaluation of Arterial stiffness

    Change from baseline to end of 20 minutes of exercise loading

Study Arms (2)

Active Video Games Intervention

ACTIVE COMPARATOR

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 consist of Rally Ball, Rive Rush and Reflex Ridge games.

Other: Active Video Games Intervention

Traditional Exercise Intervention

ACTIVE COMPARATOR

Traditional Exercise Intervention consist of active exercises for the upper extremities, active exercises for the lower extremities, active exercises for the body.

Other: Traditional Exercise Intervention

Interventions

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.

Active Video Games 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.

Traditional Exercise Intervention

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dokuz Eylul University

Izmir, Balcova, 35140, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular Diseases

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
Master of Science Student

Study Record Dates

First Submitted

May 3, 2023

First Posted

June 13, 2023

Study Start

August 1, 2023

Primary Completion

May 1, 2024

Study Completion

May 30, 2024

Last Updated

January 2, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations