Exercise TherapyNCT05794009
Virtual Reality Exercise Program for People with Type 2 Diabetes
A study testing Immersive Virtual Reality Exercise (IVRE) and Home Exercise in people with Exercise Therapy, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 55 to 80 years
- Conditions the study is for
- Exercise Therapy
- What is being tested?
- Immersive Virtual Reality Exercise (IVRE) and Home Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jun 2022to 25 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 55 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An E-therapist: an Interactive Immersive Virtual Reality Exercise Program for People with Type 2 Diabetes
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.
- Conditions
- Exercise Therapy
- Being tested
- Immersive Virtual Reality Exercise (IVRE), Home Exercise
- Keywords
- exercise, diabetes, cognitive function, virtual reality
- Medical subject headings
- Motor Activity, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immersive Virtual Reality Exercise (IVRE)Other
The IVRE program will include aerobic exercise, muscle strengthening exercise, balance and flexibility exercise.
Home ExerciseOther
Aerobic exercise, muscle strengthening exercise, balance and flexibility exercise at home.
| Study group | Role | What they receive |
|---|---|---|
| Immersive Virtual Reality Exercise (IVRE) | Experimental | 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. Receives: Other: Immersive Virtual Reality Exercise (IVRE) |
| Home Exercise | Active comparator | 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. Receives: Other: Home Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Glycated Hemoglobin (HbA1C)
HbA1c can be used to evaluate how well-controlled blood sugar has been throughout
Measured: 6 weeks
Glycated Hemoglobin (HbA1C)
HbA1c can be used to evaluate how well-controlled blood sugar has been throughout
Measured: 12 weeks
Secondary outcomes (45)
Chair Stand Test
Testing lower body strength
Measured: Baseline
Chair Stand Test
Testing lower body strength
Measured: 6 weeks
Chair Stand Test
Testing lower body strength
Measured: 12 weeks
Arm Curl Test
Testing upper body strength
Measured: Baseline
Arm Curl Test
Testing upper body strength
Measured: 6 weeks
Arm Curl Test
Testing upper body strength
Measured: 12 weeks
Chair Sit and Reach Test
Testing lower body flexibility
Measured: Baseline
Chair Sit and Reach Test
Testing lower body flexibility
Measured: 6 weeks
Chair Sit and Reach Test
Testing lower body flexibility
Measured: 12 weeks
Back Scratch Test
Testing upper body flexibility
Measured: Baseline
Back Scratch Test
Testing upper body flexibility
Measured: 6 weeks
Back Scratch Test
Testing upper body flexibility
Measured: 12 weeks
8-Foot Up and Go Test
Testing agility
Measured: Baseline
8-Foot Up and Go Test
Testing agility
Measured: 6 weeks
8-Foot Up and Go Test
Testing agility
Measured: 12 weeks
Quadriceps strength
A handheld dynamometer will be used to assess quadriceps strength.
Measured: Baseline
Quadriceps strength
A handheld dynamometer will be used to assess quadriceps strength.
Measured: 6 weeks
Quadriceps strength
A handheld dynamometer will be used to assess quadriceps strength.
Measured: 12 weeks
Hamstring Strength.
A handheld dynamometer will be used to assess hamstring strength.
Measured: Baseline
Hamstring Strength.
A handheld dynamometer will be used to assess hamstring strength.
Measured: 6 weeks
Hamstring Strength.
A handheld dynamometer will be used to assess hamstring strength.
Measured: 12 weeks
Aerobic Capacity
The six-minute walk test will be conducted to assess aerobic capacity.
Measured: Baseline
Aerobic Capacity
The six-minute walk test will be conducted to assess aerobic capacity.
Measured: 6 weeks
Aerobic Capacity
The six-minute walk test will be conducted to assess aerobic capacity.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2023
- Study start1 Jun 2022
- Primary completion25 Dec 2024
- Study completion25 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exercise TherapyStudies 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
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese University of Hong Kong
- Responsible party
- Principal investigator, Dr YU Clare Chung Wah, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05794009
- Sponsor's protocol ID
- P0036522
- Status last verified
- Mar 2023
- First submitted
- 6 Mar 2023
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be available upon request.
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An E-therapist: an Interactive Immersive Virtual Reality Exercise Program for People with Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT05794009
- Acronym / sponsor ID
- P0036522
- Conditions
- Exercise Therapy
- Keywords
- exercise, diabetes, cognitive function, virtual reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- Chinese University of Hong Kong
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 25 Dec 2024 (actual)
- Study completion
- 25 Dec 2024 (actual)
- First posted
- 31 Mar 2023 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Immersive Virtual Reality Exercise (IVRE) | Experimental | Other: Immersive Virtual Reality Exercise (IVRE)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. |
| Home Exercise | Active comparator | Other: Home ExerciseIndividuals 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. |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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%.
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| Immersive Virtual Reality Exercise (IVRE)The IVRE program will include aerobic exercise, muscle strengthening exercise, balance and flexibility exercise. | Other | Immersive Virtual Reality Exercise (IVRE) |
| Home ExerciseAerobic exercise, muscle strengthening exercise, balance and flexibility exercise at home. | Other | Home Exercise |
Primary outcome
Glycated Hemoglobin (HbA1C)
Time frame: Baseline
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.
Glycated Hemoglobin (HbA1C)
Time frame: 6 weeks
HbA1c can be used to evaluate how well-controlled blood sugar has been throughout
Glycated Hemoglobin (HbA1C)
Time frame: 12 weeks
HbA1c can be used to evaluate how well-controlled blood sugar has been throughout
45 secondary outcomes
Chair Stand Test
Time frame: Baseline
Chair Stand Test
Time frame: 6 weeks
Chair Stand Test
Time frame: 12 weeks
Arm Curl Test
Time frame: Baseline
Arm Curl Test
Time frame: 6 weeks
Arm Curl Test
Time frame: 12 weeks
Chair Sit and Reach Test
Time frame: Baseline
Chair Sit and Reach Test
Time frame: 6 weeks
Chair Sit and Reach Test
Time frame: 12 weeks
Back Scratch Test
Time frame: Baseline
Back Scratch Test
Time frame: 6 weeks
Back Scratch Test
Time frame: 12 weeks
8-Foot Up and Go Test
Time frame: Baseline
8-Foot Up and Go Test
Time frame: 6 weeks
8-Foot Up and Go Test
Time frame: 12 weeks
Quadriceps strength
Time frame: Baseline
Quadriceps strength
Time frame: 6 weeks
Quadriceps strength
Time frame: 12 weeks
Hamstring Strength.
Time frame: Baseline
Hamstring Strength.
Time frame: 6 weeks
Hamstring Strength.
Time frame: 12 weeks
Aerobic Capacity
Time frame: Baseline
Aerobic Capacity
Time frame: 6 weeks
Aerobic Capacity
Time frame: 12 weeks
Exercise Compliance
Time frame: Baseline
Exercise Compliance
Time frame: 6 weeks
Exercise Compliance
Time frame: 12 weeks
Balance
Time frame: Baseline
Balance
Time frame: 6 weeks
Balance
Time frame: 12 weeks
Postural sway
Time frame: Baseline
Postural sway
Time frame: 6 weeks
Postural sway
Time frame: 12 weeks
Forward Version of Digit-Span Test
Time frame: Baseline
Forward Version of Digit-Span Test
Time frame: 6 weeks
Forward Version of Digit-Span Test
Time frame: 12 weeks
Backward Version of Digit-Span Test
Time frame: Baseline
Backward Version of Digit-Span Test
Time frame: 6 weeks
Backward Version of Digit-Span Test
Time frame: 12 weeks
Executive Function
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
- Individual participant dataSharing planned: No. Data will be available upon request.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immersive Virtual Reality Exercise (IVRE) and Home Exercise in people with Exercise Therapy, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 13 Mar 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 Hong Kong. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycated Hemoglobin (HbA1C) (time frame: Baseline). The study lists 3 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 13 Mar 2025.