Skip to main content
OpenTrials
Completed

NCT Number: NCT05794009

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Exercise Therapy Behavior Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Motor Activity Nutritional and Metabolic Diseases

Age range

55 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Hong Kong Polytechnic University

Hong Kong

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Immersive Virtual Reality Exercise (IVRE)

Other

The IVRE program will include aerobic exercise, muscle strengthening exercise, balance and flexibility exercise.

Home exercise

Other

Aerobic exercise, muscle strengthening exercise, balance and flexibility exercise at home.

Primary outcomes

  1. 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.

  2. Glycated Hemoglobin (HbA1C)

    Time frame: 6 weeks

    HbA1c can be used to evaluate how well-controlled blood sugar has been throughout

  3. Glycated Hemoglobin (HbA1C)

    Time frame: 12 weeks

    HbA1c can be used to evaluate how well-controlled blood sugar has been throughout

Secondary outcomes

  1. Chair Stand Test

    Time frame: Baseline

    Testing lower body strength

  2. Chair Stand Test

    Time frame: 6 weeks

    Testing lower body strength

  3. Chair Stand Test

    Time frame: 12 weeks

    Testing lower body strength

  4. Arm Curl Test

    Time frame: Baseline

    Testing upper body strength

  5. Arm Curl Test

    Time frame: 6 weeks

    Testing upper body strength

  6. Arm Curl Test

    Time frame: 12 weeks

    Testing upper body strength

  7. Chair Sit and Reach Test

    Time frame: Baseline

    Testing lower body flexibility

  8. Chair Sit and Reach Test

    Time frame: 6 weeks

    Testing lower body flexibility

  9. Chair Sit and Reach Test

    Time frame: 12 weeks

    Testing lower body flexibility

  10. Back Scratch Test

    Time frame: Baseline

    Testing upper body flexibility

  11. Back Scratch Test

    Time frame: 6 weeks

    Testing upper body flexibility

  12. Back Scratch Test

    Time frame: 12 weeks

    Testing upper body flexibility

  13. 8-Foot Up and Go Test

    Time frame: Baseline

    Testing agility

  14. 8-Foot Up and Go Test

    Time frame: 6 weeks

    Testing agility

  15. 8-Foot Up and Go Test

    Time frame: 12 weeks

    Testing agility

  16. Quadriceps strength

    Time frame: Baseline

    A handheld dynamometer will be used to assess quadriceps strength.

  17. Quadriceps strength

    Time frame: 6 weeks

    A handheld dynamometer will be used to assess quadriceps strength.

  18. Quadriceps strength

    Time frame: 12 weeks

    A handheld dynamometer will be used to assess quadriceps strength.

  19. Hamstring Strength.

    Time frame: Baseline

    A handheld dynamometer will be used to assess hamstring strength.

  20. Hamstring Strength.

    Time frame: 6 weeks

    A handheld dynamometer will be used to assess hamstring strength.

  21. Hamstring Strength.

    Time frame: 12 weeks

    A handheld dynamometer will be used to assess hamstring strength.

  22. Aerobic Capacity

    Time frame: Baseline

    The six-minute walk test will be conducted to assess aerobic capacity.

  23. Aerobic Capacity

    Time frame: 6 weeks

    The six-minute walk test will be conducted to assess aerobic capacity.

  24. Aerobic Capacity

    Time frame: 12 weeks

    The six-minute walk test will be conducted to assess aerobic capacity.

  25. Exercise Compliance

    Time frame: Baseline

    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.

  26. Exercise Compliance

    Time frame: 6 weeks

    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.

  27. Exercise Compliance

    Time frame: 12 weeks

    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.

  28. Balance

    Time frame: Baseline

    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.

  29. Balance

    Time frame: 6 weeks

    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.

  30. Balance

    Time frame: 12 weeks

    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.

  31. Postural sway

    Time frame: Baseline

    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.

  32. Postural sway

    Time frame: 6 weeks

    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.

  33. Postural sway

    Time frame: 12 weeks

    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.

  34. Forward Version of Digit-Span Test

    Time frame: Baseline

    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.

  35. Forward Version of Digit-Span Test

    Time frame: 6 weeks

    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.

  36. Forward Version of Digit-Span Test

    Time frame: 12 weeks

    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.

  37. Backward Version of Digit-Span Test

    Time frame: Baseline

    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.

  38. Backward Version of Digit-Span Test

    Time frame: 6 weeks

    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.

  39. Backward Version of Digit-Span Test

    Time frame: 12 weeks

    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.

  40. Executive Function

    Time frame: Baseline

    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.

  41. Executive Function

    Time frame: 6 weeks

    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.

  42. Executive Function

    Time frame: 12 weeks

    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.

  43. Depression

    Time frame: Baseline

    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.

  44. Depression

    Time frame: 6 weeks

    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.

  45. Depression

    Time frame: 12 weeks

    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.

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Collaborators

  • Chinese University of Hong Kong

Registry information

Official study title

An E-therapist: an Interactive Immersive Virtual Reality Exercise Program for People with Type 2 Diabetes

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Mar 31, 2023
Registry last updated
Mar 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.