Clinical trial NCT06777927: Exergaming Training Among Hypertensive Patients
Official title: Effects of Exergaming Training on Balance Among Hypertensive Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypertension
Keywords: Balance
Exergaming
Gait
Brain derived neurotrophic factor biomarker
Biopsychosocial
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2025-01-16
Enrollment: 81
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Gait and Balance App
timeFrame: Baseline before provision of interventions
measure: Gait and Balance App
timeFrame: After 4 weeks of interventions
measure: Gait and Balance App
timeFrame: After 8 weeks of interventions
measure: Brain-derived neurotrophic factor (BDNF) biomarker:
timeFrame: Baseline before provision of interventions
measure: Brain Derived Neurotrophic Factor Biomarker
timeFrame: After 8 weeks of interventions
measure: Exercise Enjoyment Questionnaire (EEQ)
timeFrame: After 8 weeks of interventions
measure: The Montreal Cognitive Assessment (MoCA)
timeFrame: Baseline before provision of interventions
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: After 4 weeks of interventions
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: After 8 weeks of interventions
measure: 3 Min Walk Test
timeFrame: Baseline before provision of interventions
measure: 3 Min Walk Test
timeFrame: After 4 weeks of interventions
measure: 3-min walk Test
timeFrame: After 8 weeks of interventions
measure: Social Functioning Questionnaire (SFQ)
timeFrame: Baseline before provision of interventions
measure: Social Functioning Questionnaire (SFQ)
timeFrame: After 4 weeks of interventions
measure: Social Functioning Questionnaire (SFQ)
timeFrame: After 8 weeks of interventions
measure: SF -36 Quality of Life Questionnaire
timeFrame: Baseline before provision of interventions
measure: SF -36 Quality of Life Questionnaire
timeFrame: After 4 weeks of interventions
measure: SF -36 Quality of Life Questionnaire
timeFrame: After 8 weeks of interventions
measure: Timed up and Go (TUG)
timeFrame: Baseline before provision of interventions
measure: Timed up and Go (TUG)
timeFrame: After 4 weeks of interventions
measure: Timed up and Go (TUG)
timeFrame: After 8 weeks of interventions
measure: Berg Balance Scale (BBS)
timeFrame: Baseline before provision of interventions
measure: Berg Balance Scale (BBS)
timeFrame: After 4 weeks of interventions
measure: Berg Balance Scale (BBS)
timeFrame: After 8 weeks of interventions
Secondary outcomes:
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Foundation University
state: Federal
Study officials:
affiliation: Riphah International University Islamabad
name: Imran Amjad, PhD
role: PRINCIPAL_INVESTIGATOR
References: