HypertensionNCT06777927
Exergaming Training Among Hypertensive Patients
A study testing Exercise in people with Hypertension, run by Riphah International University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 55 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 sitePakistan
- Study dates
- 16 Jan 2025to 1 Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
- Any race or gender with age 20 or older
- No history of any orthopedic, neurological, Pulmonary or psychological disorders, Cognitive impairments etc.
- Had not performed physical activity in the previous three months.
Who cannot join
- Grade III or grade IV heart failure according to the New York Heart Association (NYHA) Functional Classification.
- Recent acute myocardial infarction; unstable angina; acute pericarditis. pulmonary hypertension; uncontrolled diabetes mellitus; Hypertensive crises or uncontrolled Hypertension or Pregnancy
- Patients who had three consecutive absences during the intervention
- 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
- Pain with ambulation or dizziness when standing or walking.
- Contraindications to treadmill walking or VR gaming
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Foundation University
Islamabad, Federal, 44000
Sana Bashir
About this study
Official title: 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.
- Conditions
- Hypertension
- Being tested
- Exercise, No intervention
- Keywords
- Balance, Exergaming, Gait, Brain derived neurotrophic factor biomarker, Biopsychosocial
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Also called Exergaming
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.
ExerciseOther
Also called Treadmill
The subjects would be doing treadmill training within moderate intensity target heart rate.
No interventionOther
The subjects would not be given any intervention and would be used as controls.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Other | The group will not be provided with any interventions and would be used as controls. Receives: Other: No intervention |
| Conventional Exercise Training | Active comparator | 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. Receives: Other: Exercise |
| Exergaming Training Group | Experimental | The group would be doing exergaming 3 days a week for 8 weeks (24 sessions) within target heart rate of moderate intensity. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: After 8 weeks of interventions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2025
- Study start16 Jan 2025
- Primary completion16 Oct 2025 (estimated)
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 81 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Imran Amjad, PhD, Principal investigator, Riphah International University Islamabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06777927
- Sponsor's protocol ID
- RIPHAH/RCRS/REC/Letter-01198
- Status last verified
- Jan 2025
- First submitted
- 10 Jan 2025
- Last updated
- 23 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Exergaming Training on Balance Among Hypertensive Patients
- ClinicalTrials.gov ID
- NCT06777927
- Acronym / sponsor ID
- RIPHAH/RCRS/REC/Letter-01198
- Conditions
- Hypertension
- Keywords
- Balance, Exergaming, Gait, Brain derived neurotrophic factor biomarker, Biopsychosocial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 81 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 16 Jan 2025 (actual)
- Primary completion
- 16 Oct 2025 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 16 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | Other | Other: No interventionThe group will not be provided with any interventions and would be used as controls. |
| Conventional Exercise Training | Active comparator | Other: ExerciseThe 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. |
| Exergaming Training Group | Experimental | Other: ExerciseThe group would be doing exergaming 3 days a week for 8 weeks (24 sessions) within target heart rate of moderate intensity. |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
- Any race or gender with age 20 or older
- No history of any orthopedic, neurological, Pulmonary or psychological disorders, Cognitive impairments etc.
- Had not performed physical activity in the previous three months.
Key exclusion criteria (6 listed)
- Grade III or grade IV heart failure according to the New York Heart Association (NYHA) Functional Classification.
- Recent acute myocardial infarction; unstable angina; acute pericarditis. pulmonary hypertension; uncontrolled diabetes mellitus; Hypertensive crises or uncontrolled Hypertension or Pregnancy
- Patients who had three consecutive absences during the intervention
- 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
- Pain with ambulation or dizziness when standing or walking.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseAlso: ExergamingThe 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 | Exergaming Training Group |
| ExerciseAlso: TreadmillThe subjects would be doing treadmill training within moderate intensity target heart rate. | Other | Conventional Exercise Training |
| No interventionThe subjects would not be given any intervention and would be used as controls. | Other | Control group |
Primary outcome
Gait and Balance App
Time frame: Baseline before provision 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.
Gait and Balance App
Time frame: After 4 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.
Gait and Balance App
Time frame: 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:
Time frame: 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
Time frame: 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.
Exercise Enjoyment Questionnaire (EEQ)
Time frame: 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.
The Montreal Cognitive Assessment (MoCA)
Time frame: 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)
Time frame: After 4 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.
Montreal Cognitive Assessment (MoCA)
Time frame: 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
Time frame: Baseline before provision 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
Time frame: 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
Time frame: 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)
Time frame: Baseline before provision 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.
Social Functioning Questionnaire (SFQ)
Time frame: After 4 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.
Social Functioning Questionnaire (SFQ)
Time frame: 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
Time frame: Baseline before provision 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.
SF -36 Quality of Life Questionnaire
Time frame: After 4 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.
SF -36 Quality of Life Questionnaire
Time frame: 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)
Time frame: Baseline before provision 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
Timed up and Go (TUG)
Time frame: After 4 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
Timed up and Go (TUG)
Time frame: 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)
Time frame: Baseline before provision 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.
Berg Balance Scale (BBS)
Time frame: After 4 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.
Berg Balance Scale (BBS)
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Imran Amjad, PhD principal investigator
Riphah International University Islamabad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Hypertension, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sana Bashir, MS-CPPT (+92 3218529475, sana.bashir65@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait and Balance App (time frame: Baseline before provision of interventions). The study lists 24 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2025.