Exergaming Training Among Hypertensive Patients

Not Applicable

Recruiting

• Conditions: Hypertension

• Registration Number: NCT06777927
• Lead Sponsor: Riphah International University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-10
• Study First Submitted QC: 2025-01-10
• Study Start: 2025-01-16
• Study First Posted: 2025-01-16
• Last Update Submitted: 2025-01-22
• Last Update Posted: 2025-01-23
• Primary Completion: 2025-10-16
• Study Completion: 2025-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 81

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Exercise Enjoyment Questionnaire (EEQ)	After 8 weeks of interventions	Exergame Enjoyment Questionnaire (EEQ), a new 20-item questionnaire for measuring how much players enjoyed an exergame. Thus, the minimum score is 20 points, and the maximum score is 100 points. Higher is better, indicating more enjoyment. Questions are intended to be administered to users immediately after playing an exergame with a high average agreement percentage per question (of \~85%), EEQ will only be taken in Exergaming Group after 8 weeks of intervention.
Gait and Balance App	After 8 weeks of interventions	A new smartphone app (the Gait \& Balance app) uses a structured and efficient protocol to evaluate performance during static balance and dynamic gait tasks that are commonly used in clinical practice. With the use of sensors embedded in standard smartphones, this technology has the potential to provide clinicians and sports professionals with easy access to more accurate and sensitive measures of balance and gait. This enhanced ability to assess and monitor progress may facilitate clinical decision making and optimize rehabilitation.
Brain-derived neurotrophic factor (BDNF) biomarker:	Baseline before provision of interventions	Brain-Derived Neurotrophic Factor (BDNF) is a protein of the neurotrophin family encoded by the BDNF gene that plays an important role in the modulation of synaptic plasticity processes underlying learning, memory, and behavior. This protein plays a fundamental role in neurodevelopment, acting on neurogenesis and on the differentiation and maturation of neurotransmitter systems such as the brain stress system and the brain reward and motivation system. Evidence shows that BDNF reduced levels are linked to reduced synaptic plasticity and neuronal atrophy, while elevated levels are associated with survival and neuronal differentiation and brain plasticity.
Brain Derived Neurotrophic Factor Biomarker	After 8 weeks of interventions	Brain-Derived Neurotrophic Factor (BDNF) is a protein of the neurotrophin family encoded by the BDNF gene that plays an important role in the modulation of synaptic plasticity processes underlying learning, memory, and behavior. This protein plays a fundamental role in neurodevelopment, acting on neurogenesis and on the differentiation and maturation of neurotransmitter systems such as the brain stress system and the brain reward and motivation system. Evidence shows that BDNF reduced levels are linked to reduced synaptic plasticity and neuronal atrophy, while elevated levels are associated with survival and neuronal differentiation and brain plasticity.
The Montreal Cognitive Assessment (MoCA)	Baseline before provision of interventions	It is a validated brief cognitive screening measure that is commonly employed in clinical practice and research settings. The MoCA evaluates several cognitive domains including visuospatial ability, executive functioning, language, memory, attention, and orientation. 18-25 points: Mild cognitive impairment. 10-17 points: Moderate cognitive impairment. Fewer than 10 points: Severe cognitive impairment.
Montreal Cognitive Assessment (MoCA)	After 8 weeks of interventions	It is a validated brief cognitive screening measure that is commonly employed in clinical practice and research settings. The MoCA evaluates several cognitive domains including visuospatial ability, executive functioning, language, memory, attention, and orientation. 18-25 points: Mild cognitive impairment. 10-17 points: Moderate cognitive impairment. Fewer than 10 points: Severe cognitive impairment.
3 Min Walk Test	After 4 weeks of interventions	The three-minute walk test has proven to be reproducible and is well tolerated by patients. It evaluates the distance a person can walk on a flat, rigid surface in 3 minutes. Its main objective is to determine exercise tolerance and oxygen saturation during submaximal exercise
3-min walk Test	After 8 weeks of interventions	The three-minute walk test has proven to be reproducible and is well tolerated by patients. It evaluates the distance a person can walk on a flat, rigid surface in 3 minutes. Its main objective is to determine exercise tolerance and oxygen saturation during submaximal exercise
Social Functioning Questionnaire (SFQ)	After 8 weeks of interventions	Inventory/Questionnaire, each of the 8 items of the SFQ is scored on a four- point scale (0-3) with a total possible score of 24. The Social Functioning is a Rapid and Robust Measure of Perceived Functioning. Test content may be reproduced and used for non-commercial research and educational purposes without seeking written permission. Distribution must be controlled, meaning only to the participants engaged in the research or enrolled in the educational activity. The Social Functioning Questionnaire (SFQ), an eight-item self-report scale (score range 0-24), is a semi- structured interview which has been used primarily with non-psychotic patients and has good test-retest and inter-rater reliability as well as construct validity. It is a quick assessment of perceived social function.
SF -36 Quality of Life Questionnaire	After 8 weeks of interventions	The SF-36 is a self-reported outcome measure assessing the impact of health on an individual everyday life. It is often used as a quality-of-life measure. The SF- 36 uses eight domains: used as a general measure of health so can be used with the general population. It is a promising instrument for measuring health perception in a general population. It is easy to use, acceptable to patients, and fulfils stringent criteria of reliability and validity. To score the SF-36, scales are standardized with a scoring algorithm or by the SF-36v2 scoring software to obtain a score ranging from 0 to 100. Higher scores indicate better health status, and a mean score of 50 has been articulated as a normative value for all scales.
Timed up and Go (TUG)	After 8 weeks of interventions	This test measures the dynamic balance and functional mobility in older adults, as well as in the neurological population. The Timed Up \& Go Test has been found to be correlated with falls and those who require 30 s or more to complete the Timed Up \& Go tend to be dependent on others for care
Berg Balance Scale (BBS)	After 8 weeks of interventions	The Berg balance scale helps determine one's ability to balance safely. The Berg balance scale was created in 1989, it was intended to assess both balance and fall risk. The scale consists of 14 tasks that a healthcare provider scores on a scale from 0 to 4. The higher the score, the better is the better is the balance. The highest possible score is 56. The Berg balance scale test takes about 15 to 20 minutes to complete. 0 to 20: A person with a score in this range will likely need the assistance of a wheelchair to move around safely. 21 to 40: A person with a score in this range will need some type of walking assistance, like a cane or a walker. 41 to 56: A person with a score in this range is considered independent and should be able to move around safely without assistance. It is widely used in clinical settings and is much valid and reliable.

Trial Locations

Locations (1)

Foundation University; 🇵🇰 Islamabad, Federal, Pakistan