Virtual Reality Exercise Program for People With Type 2 Diabetes

Study Overview
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Brief Summary
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The purpose of this study is to examine the effectiveness of a virtual reality (VR) based rehabilitation protocol for improvement of blood glucose control and exercise compliance of patients. Subjects aged 55-85 diagnosed with Type 2 diabetes will be recruited. A written consent will be obtained from subjects. Subjects recruited will be randomly divided into one of the two groups. The VR group will receive an exercise program conducted in elderly centre or a control group will receive home exercise program. The 12-week exercise program will be conducted three times per week and each session will last for one hour. Assessment that takes about one hour to complete will be carried out at baseline, mid-way (6th week) and after the 12-week exercise training. Assessment items include physical, psychosocial and cognitive function. Also, blood test on HbA1c will be carried out at baseline and at the end of the 12-week training. During this course of research, subjects are strongly advised to stay with their present lifestyle and medication.

Official Title
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An E-therapist: An Interactive Immersive Virtual Reality Exercise Program for People With Type 2 Diabetes

Conditions
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Exercise Therapy

Intervention / Treatment
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* Other: Immersive Virtual Reality Exercise (IVRE)
* Other: Home Exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Individuals aged between 55 and 80 years with a confirmed diagnosis of type 2 diabetes mellitus (T2DM) and an HbA1c of ≥ 6.5% and ≤ 11%. Exclusion Criteria: Individuals will be excluded if they have a history of any of the following conditions: cardiac arrest, complex dysrhythmias at rest, complicated myocardial infarction or revascularization procedure, presence of congestive failure, presence of angina, signs or symptoms of post-event myocardial ischemia, renal impairment or proteinuria, hepatic impairment, severe gout or hyperuricemia or uncontrolled hypertension, a fall within the last year, musculoskeletal impairment such as inability to walk independently (after stroke or serious arthritis), neurocognitive disorder, or other diseases that limit their ability to engage in physical activities will be excluded. Individuals enrolled in other physical training programs will also be excluded to ensure any true effect of the proposed intervention can be captured.

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Recruited participants from community centers will be randomly allocated into either an IVRE program or a home-based exercise program that is identical to the intervention group (control group) using computer-generated random numbers. This will be a single-blinded randomized controlled trial (RCT), where outcome assessor(s) will be blinded to the allocation of participants throughout the study. Participants will be informed of their allocated exercise protocols, and they will be advised not to disclose their allocated intervention to the assessor(s) or other participants.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immersive Virtual Reality Exercise (IVRE)<br>VR exercise training for at least three times a week for 12 consecutive weeks (a total of 36 sessions) guided by the e-therapist: The tailored VR-based exercise program involves aerobic and resistance exercises, and VR games. | Other: Immersive Virtual Reality Exercise (IVRE)<br>* The IVRE program will include aerobic exercise, muscle strengthening exercise, balance and flexibility exercise.<br>|
| Active Comparator: Home Exercise<br>Individuals randomized to the control group will attend a briefing session prior to the start of the program to complete demographic data collection and physical assessment. They will be given an exercise booklet and guided through a set of home-based exercises (identical training to the intervention group except for VR games) in the briefing session. Stepping exercises will be implemented as a substitution of cycling as an aerobic exercise training at home. | Other: Home Exercise<br>* Aerobic exercise, muscle strengthening exercise, balance and flexibility exercise at home.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycated Hemoglobin (HbA1C) | HbA1c can be used to evaluate how well-controlled blood sugar has been throughout exercise program. Blood tests will be performed by a nurse at the community center and HbA1c tests will be conducted by a private medical laboratory. | Baseline | 
| Glycated Hemoglobin (HbA1C) | HbA1c can be used to evaluate how well-controlled blood sugar has been throughout | 6 weeks | 
| Glycated Hemoglobin (HbA1C) | HbA1c can be used to evaluate how well-controlled blood sugar has been throughout | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chair Stand Test | Testing lower body strength | Baseline | 
| Chair Stand Test | Testing lower body strength | 6 weeks | 
| Chair Stand Test | Testing lower body strength | 12 weeks | 
| Arm Curl Test | Testing upper body strength | Baseline | 
| Arm Curl Test | Testing upper body strength | 6 weeks | 
| Arm Curl Test | Testing upper body strength | 12 weeks | 
| Chair Sit and Reach Test | Testing lower body flexibility | Baseline | 
| Chair Sit and Reach Test | Testing lower body flexibility | 6 weeks | 
| Chair Sit and Reach Test | Testing lower body flexibility | 12 weeks | 
| Back Scratch Test | Testing upper body flexibility | Baseline | 
| Back Scratch Test | Testing upper body flexibility | 6 weeks | 
| Back Scratch Test | Testing upper body flexibility | 12 weeks | 
| 8-Foot Up and Go Test | Testing agility | Baseline | 
| 8-Foot Up and Go Test | Testing agility | 6 weeks | 
| 8-Foot Up and Go Test | Testing agility | 12 weeks | 
| Quadriceps strength | A handheld dynamometer will be used to assess quadriceps strength. | Baseline | 
| Quadriceps strength | A handheld dynamometer will be used to assess quadriceps strength. | 6 weeks | 
| Quadriceps strength | A handheld dynamometer will be used to assess quadriceps strength. | 12 weeks | 
| Hamstring Strength. | A handheld dynamometer will be used to assess hamstring strength. | Baseline | 
| Hamstring Strength. | A handheld dynamometer will be used to assess hamstring strength. | 6 weeks | 
| Hamstring Strength. | A handheld dynamometer will be used to assess hamstring strength. | 12 weeks | 
| Aerobic Capacity | The six-minute walk test will be conducted to assess aerobic capacity. | Baseline | 
| Aerobic Capacity | The six-minute walk test will be conducted to assess aerobic capacity. | 6 weeks | 
| Aerobic Capacity | The six-minute walk test will be conducted to assess aerobic capacity. | 12 weeks | 
| Exercise Compliance | Participant's compliance to the training program will be measured using Quartrics, a web-based survey system. Participants will receive a verbal reminder from research assistants to attend training sessions. | Baseline | 
| Exercise Compliance | Participant's compliance to the training program will be measured using Quartrics, a web-based survey system. Participants will receive a verbal reminder from research assistants to attend training sessions. | 6 weeks | 
| Exercise Compliance | Participant's compliance to the training program will be measured using Quartrics, a web-based survey system. Participants will receive a verbal reminder from research assistants to attend training sessions. | 12 weeks | 
| Balance | The Mini Balance Evaluation Systems Test (Mini-BEST) will be used to assess participant's ability to safely balance during a series of predetermined tasks. | Baseline | 
| Balance | The Mini Balance Evaluation Systems Test (Mini-BEST) will be used to assess participant's ability to safely balance during a series of predetermined tasks. | 6 weeks | 
| Balance | The Mini Balance Evaluation Systems Test (Mini-BEST) will be used to assess participant's ability to safely balance during a series of predetermined tasks. | 12 weeks | 
| Postural sway | Postural sway will be evaluated using a force plate, which is an instrument to measure static balance and dynamic balance. Postural sway will be assessed under both eyes opened and closed conditions. | Baseline | 
| Postural sway | Postural sway will be evaluated using a force plate, which is an instrument to measure static balance and dynamic balance. Postural sway will be assessed under both eyes opened and closed conditions. | 6 weeks | 
| Postural sway | Postural sway will be evaluated using a force plate, which is an instrument to measure static balance and dynamic balance. Postural sway will be assessed under both eyes opened and closed conditions. | 12 weeks | 
| Forward Version of Digit-Span Test | Forward Version of Digit-Span Test will be used to assess short-term memory. Score ranges from 0 to 14. The higher score indicates the better memory. | Baseline | 
| Forward Version of Digit-Span Test | Forward Version of Digit-Span Test will be used to assess short-term memory. Score ranges from 0 to 14. The higher score indicates the better memory. | 6 weeks | 
| Forward Version of Digit-Span Test | Forward Version of Digit-Span Test will be used to assess short-term memory. Score ranges from 0 to 14. The higher score indicates the better memory. | 12 weeks | 
| Backward Version of Digit-Span Test | Backward Version of Digit-Span Test will be used to assess short-term memory. Score ranges from 0 to 14. The higher score indicates the better memory. | Baseline | 
| Backward Version of Digit-Span Test | Backward Version of Digit-Span Test will be used to assess short-term memory. Score ranges from 0 to 14. The higher score indicates the better memory. | 6 weeks | 
| Backward Version of Digit-Span Test | Backward Version of Digit-Span Test will be used to assess short-term memory. Score ranges from 0 to 14. The higher score indicates the better memory. | 12 weeks | 
| Executive Function | Wechsler Adult Intelligence Scale Digit-Symbol-Coding will be used to assess the executive function. The score ranges from 0 to 133. The higher score indicate the better executive function. | Baseline | 
| Executive Function | Wechsler Adult Intelligence Scale Digit-Symbol-Coding will be used to assess the executive function. The score ranges from 0 to 133. The higher score indicate the better executive function. | 6 weeks | 
| Executive Function | Wechsler Adult Intelligence Scale Digit-Symbol-Coding will be used to assess the executive function. The score ranges from 0 to 133. The higher score indicate the better executive function. | 12 weeks | 
| Depression | The 17-item version of the English and Chinese Diabetes Distress Scale will be used to assess the mental health status. The mean item score ranges from 1 to 6. The mean item score of 3 or above (moderate distress) is considered as the level of distress worthy of clinical attention. | Baseline | 
| Depression | The 17-item version of the English and Chinese Diabetes Distress Scale will be used to assess the mental health status. The mean item score ranges from 1 to 6. The mean item score of 3 or above (moderate distress) is considered as the level of distress worthy of clinical attention. | 6 weeks | 
| Depression | The 17-item version of the English and Chinese Diabetes Distress Scale will be used to assess the mental health status. The mean item score ranges from 1 to 6. The mean item score of 3 or above (moderate distress) is considered as the level of distress worthy of clinical attention. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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exercise, diabetes, cognitive function, virtual reality