Exergaming Training Among Hypertensive Patients

NCT ID: NCT06777927

Last Updated: 2025-01-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 81 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-16
• Study Completion Date: 2025-11-01

Brief Summary

Since Hypertension affects all body systems and importantly postural balance control. So, the evidence indicates a strong link and connection between balance and hypertension through somatosensory, visual, vestibular, musculoskeletal, and CNS integration of inputs from both peripheral and motor systems. Therefore, to fill this gap of how much balance and each of its aspects/components are affected, this study will be done for a detailed examination of this genuine integration and clinical interaction among hypertensive with game-based techniques on all three balance components (concerning Intensity, frequency, duration and dosage of VRET). Secondly, on the other hand (CR) programs, have shown very low compliance with recommended Physical Activity, which is why; by utilising this alternative, Virtual reality exergaming can be used as a quick, appropriate and equivalent alternative to traditional exercise programs. Also, in future, it could be suggested with promising effects in the provision of engaging, goal-oriented training for patients with hypertensive besides a sound, economical and clinically beneficial alternative to traditional Cardiac Rehabilitation. Finally, by exploring detailed clinical integration of Postural Balance with Hypertension using Virtual Reality the study will be able to highlight hypertension as a potent risk factor for future impaired balance and risks of falls. Thereby, hypertension's early identification (considering all biological, psychological, and social factors) and prevention may avert hypertensive to future debilitating complications and outcomes as a result of it.

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control group

The group will not be provided with any interventions and would be used as controls.

Group Type: OTHER

No intervention

Intervention Type: OTHER

The subjects would not be given any intervention and would be used as controls.

Conventional Exercise Training

The subjects in the group would be doing treadmill training 3 days a week for 8 weeks (24 sessions) within target heart rate of moderate intensity.

Group Type: ACTIVE_COMPARATOR

Exercise

Intervention Type: OTHER

The subjects would be doing treadmill training within moderate intensity target heart rate.

Exergaming Training Group

The group would be doing exergaming 3 days a week for 8 weeks (24 sessions) within target heart rate of moderate intensity.

Group Type: EXPERIMENTAL

Exercise

Intervention Type: OTHER

The participants would be playing exergames using XBOX-360 Kinect. Multiple games would be selected for the participants to play. The player would be upgraded to next levels of games after completing the initial levels.

Interventions

Exercise

The participants would be playing exergames using XBOX-360 Kinect. Multiple games would be selected for the participants to play. The player would be upgraded to next levels of games after completing the initial levels.

Intervention Type: OTHER

Exercise

The subjects would be doing treadmill training within moderate intensity target heart rate.

Intervention Type: OTHER

No intervention

The subjects would not be given any intervention and would be used as controls.

Intervention Type: OTHER

Other Intervention Names

Exergaming; Treadmill

Eligibility Criteria

Inclusion Criteria

1. Diagnosis of Community dwelling controlled Hypertensive (particularly Stage 1, 130 to 139 (systolic) or 80 to 89 (diastolic) or Stage 2 hypertension from 140 or higher (systolic) or 90 (diastolic) if present with any (controlled diabetes or overweight patients) with a medical referral form for medical specialist with physiotherapeutic treatment provided by the local public or private healthcare system

2. Any race or gender with age 20 or older

3. No history of any orthopedic, neurological, Pulmonary or psychological disorders, Cognitive impairments etc.

4. Had not performed physical activity in the previous three months.

Exclusion Criteria

1. Grade III or grade IV heart failure according to the New York Heart Association (NYHA) Functional Classification.

2. Recent acute myocardial infarction; unstable angina; acute pericarditis. pulmonary hypertension; uncontrolled diabetes mellitus; Hypertensive crises or uncontrolled Hypertension or Pregnancy

3. Patients who had three consecutive absences during the intervention

4. Unable to answer or understand the gaming or exercise protocols and quality of life questionnaires and fulfil the exercise protocols, due to any severe cognitive deficit

5. Pain with ambulation or dizziness when standing or walking.

6. Contraindications to treadmill walking or VR gaming

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Imran Amjad, PhD

Role: PRINCIPAL_INVESTIGATOR

Riphah International University Islamabad

Locations

Foundation University

Islamabad, Federal, Pakistan

Site Status: RECRUITING

Countries

Pakistan

Central Contacts

Sana Bashir, MS-CPPT

Role: CONTACT

sana.bashir65@gmail.com

+92 3218529475

Imran Amjad, PhD

Role: CONTACT

imran.amjad@riphah.edu.pk

+92 3324390125

Facility Contacts

Sana Bashir

Role: primary

Other Identifiers

RIPHAH/RCRS/REC/Letter-01198

Identifier Type: -

Identifier Source: org_study_id