Exergaming Training Among Hypertensive Patients

Effects of Exergaming Training on Balance Among Hypertensive Patients

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.

Study Overview

• Status: Recruiting
• Conditions: Hypertension
• Intervention / Treatment: Other: No intervention; Other: Exercise; Other: Exercise

• Study Type: Interventional
• Enrollment (Estimated): 81
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sana Bashir, MS-CPPT; Phone Number: +92 3218529475; Email: sana.bashir65@gmail.com
• Study Contact Backup: Name: Imran Amjad, Phd; Phone Number: +92 3324390125; Email: imran.amjad@riphah.edu.pk

Study Locations

• Pakistan
  • Federal
    • Islamabad, Federal, Pakistan, 44000
      • Recruiting
      • Foundation University
      • Contact: Sana Bashir

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Control group; The group will not be provided with any interventions and would be used as controls.	Other: No intervention; The subjects would not be given any intervention and would be used as controls.
Active Comparator: 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.	Other: 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.; Other Names: Exergaming; Other: Exercise; The subjects would be doing treadmill training within moderate intensity target heart rate.; Other Names: Treadmill
Experimental: 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.	Other: 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.; Other Names: Exergaming; Other: Exercise; The subjects would be doing treadmill training within moderate intensity target heart rate.; Other Names: Treadmill

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gait and Balance App	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.	Baseline before provision of interventions
Gait and Balance App	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.	After 4 weeks of interventions
Gait and Balance App	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.	After 8 weeks of interventions
Brain-derived neurotrophic factor (BDNF) biomarker:	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.	Baseline before provision of interventions
Brain Derived Neurotrophic Factor Biomarker	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.	After 8 weeks of interventions
Exercise Enjoyment Questionnaire (EEQ)	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.	After 8 weeks of interventions
The Montreal Cognitive Assessment (MoCA)	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.	Baseline before provision of interventions
Montreal Cognitive Assessment (MoCA)	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.	After 4 weeks of interventions
Montreal Cognitive Assessment (MoCA)	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.	After 8 weeks of interventions
3 Min Walk Test	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	Baseline before provision of interventions
3 Min Walk Test	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	After 4 weeks of interventions
3-min walk Test	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	After 8 weeks of interventions
Social Functioning Questionnaire (SFQ)	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.	Baseline before provision of interventions
Social Functioning Questionnaire (SFQ)	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.	After 4 weeks of interventions
Social Functioning Questionnaire (SFQ)	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.	After 8 weeks of interventions
SF -36 Quality of Life Questionnaire	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.	Baseline before provision of interventions
SF -36 Quality of Life Questionnaire	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.	After 4 weeks of interventions
SF -36 Quality of Life Questionnaire	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.	After 8 weeks of interventions
Timed up and Go (TUG)	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	Baseline before provision of interventions
Timed up and Go (TUG)	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	After 4 weeks of interventions
Timed up and Go (TUG)	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	After 8 weeks of interventions
Berg Balance Scale (BBS)	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.	Baseline before provision of interventions
Berg Balance Scale (BBS)	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.	After 4 weeks of interventions
Berg Balance Scale (BBS)	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.	After 8 weeks of interventions

Collaborators and Investigators

• Sponsor: Riphah International University
• Investigators: Principal Investigator: Imran Amjad, PhD, Riphah International University Islamabad

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2025
• Primary Completion (Estimated): October 16, 2025
• Study Completion (Estimated): November 1, 2025

Study Registration Dates

• First Submitted: January 10, 2025
• First Submitted That Met QC Criteria: January 10, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 22, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Balance; Gait; Exergaming; Biopsychosocial; Brain derived neurotrophic factor biomarker
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypertension
• Other Study ID Numbers: RIPHAH/RCRS/REC/Letter-01198

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No