search
Back to results

Virtual Reality Exercise Program for People With Type 2 Diabetes

Primary Purpose

Exercise Therapy

Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Immersive Virtual Reality Exercise (IVRE)
Home Exercise
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Exercise Therapy focused on measuring exercise, diabetes, cognitive function, virtual reality

Eligibility Criteria

55 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Hong Kong Polytechnic UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Immersive Virtual Reality Exercise (IVRE)

Home Exercise

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
Glycated Hemoglobin (HbA1C)
HbA1c can be used to evaluate how well-controlled blood sugar has been throughout
Glycated Hemoglobin (HbA1C)
HbA1c can be used to evaluate how well-controlled blood sugar has been throughout

Secondary Outcome Measures

Chair Stand Test
Testing lower body strength
Chair Stand Test
Testing lower body strength
Chair Stand Test
Testing lower body strength
Arm Curl Test
Testing upper body strength
Arm Curl Test
Testing upper body strength
Arm Curl Test
Testing upper body strength
Chair Sit and Reach Test
Testing lower body flexibility
Chair Sit and Reach Test
Testing lower body flexibility
Chair Sit and Reach Test
Testing lower body flexibility
Back Scratch Test
Testing upper body flexibility
Back Scratch Test
Testing upper body flexibility
Back Scratch Test
Testing upper body flexibility
8-Foot Up and Go Test
Testing agility
8-Foot Up and Go Test
Testing agility
8-Foot Up and Go Test
Testing agility
Quadriceps strength
A handheld dynamometer will be used to assess quadriceps strength.
Quadriceps strength
A handheld dynamometer will be used to assess quadriceps strength.
Quadriceps strength
A handheld dynamometer will be used to assess quadriceps strength.
Hamstring Strength.
A handheld dynamometer will be used to assess hamstring strength.
Hamstring Strength.
A handheld dynamometer will be used to assess hamstring strength.
Hamstring Strength.
A handheld dynamometer will be used to assess hamstring strength.
Aerobic Capacity
The six-minute walk test will be conducted to assess aerobic capacity.
Aerobic Capacity
The six-minute walk test will be conducted to assess aerobic capacity.
Aerobic Capacity
The six-minute walk test will be conducted to assess aerobic capacity.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
March 6, 2023
Last Updated
March 20, 2023
Sponsor
The Hong Kong Polytechnic University
Collaborators
Chinese University of Hong Kong
search

1. Study Identification

Unique Protocol Identification Number
NCT05794009
Brief Title
Virtual Reality Exercise Program for People With Type 2 Diabetes
Official Title
An E-therapist: An Interactive Immersive Virtual Reality Exercise Program for People With Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
March 31, 2025 (Anticipated)
Study Completion Date
March 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hong Kong Polytechnic University
Collaborators
Chinese University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exercise Therapy
Keywords
exercise, diabetes, cognitive function, virtual reality

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Masking Description
Outcome assessor(s) will be blinded to the allocation of participants throughout the study. The name of the participants and the allocation will be removed from the assessment sheet.
Allocation
Randomized
Enrollment
130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Immersive Virtual Reality Exercise (IVRE)
Arm Type
Experimental
Arm Description
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.
Arm Title
Home Exercise
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Immersive Virtual Reality Exercise (IVRE)
Intervention Description
The IVRE program will include aerobic exercise, muscle strengthening exercise, balance and flexibility exercise.
Intervention Type
Other
Intervention Name(s)
Home Exercise
Intervention Description
Aerobic exercise, muscle strengthening exercise, balance and flexibility exercise at home.
Primary Outcome Measure Information:
Title
Glycated Hemoglobin (HbA1C)
Description
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.
Time Frame
Baseline
Title
Glycated Hemoglobin (HbA1C)
Description
HbA1c can be used to evaluate how well-controlled blood sugar has been throughout
Time Frame
6 weeks
Title
Glycated Hemoglobin (HbA1C)
Description
HbA1c can be used to evaluate how well-controlled blood sugar has been throughout
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Chair Stand Test
Description
Testing lower body strength
Time Frame
Baseline
Title
Chair Stand Test
Description
Testing lower body strength
Time Frame
6 weeks
Title
Chair Stand Test
Description
Testing lower body strength
Time Frame
12 weeks
Title
Arm Curl Test
Description
Testing upper body strength
Time Frame
Baseline
Title
Arm Curl Test
Description
Testing upper body strength
Time Frame
6 weeks
Title
Arm Curl Test
Description
Testing upper body strength
Time Frame
12 weeks
Title
Chair Sit and Reach Test
Description
Testing lower body flexibility
Time Frame
Baseline
Title
Chair Sit and Reach Test
Description
Testing lower body flexibility
Time Frame
6 weeks
Title
Chair Sit and Reach Test
Description
Testing lower body flexibility
Time Frame
12 weeks
Title
Back Scratch Test
Description
Testing upper body flexibility
Time Frame
Baseline
Title
Back Scratch Test
Description
Testing upper body flexibility
Time Frame
6 weeks
Title
Back Scratch Test
Description
Testing upper body flexibility
Time Frame
12 weeks
Title
8-Foot Up and Go Test
Description
Testing agility
Time Frame
Baseline
Title
8-Foot Up and Go Test
Description
Testing agility
Time Frame
6 weeks
Title
8-Foot Up and Go Test
Description
Testing agility
Time Frame
12 weeks
Title
Quadriceps strength
Description
A handheld dynamometer will be used to assess quadriceps strength.
Time Frame
Baseline
Title
Quadriceps strength
Description
A handheld dynamometer will be used to assess quadriceps strength.
Time Frame
6 weeks
Title
Quadriceps strength
Description
A handheld dynamometer will be used to assess quadriceps strength.
Time Frame
12 weeks
Title
Hamstring Strength.
Description
A handheld dynamometer will be used to assess hamstring strength.
Time Frame
Baseline
Title
Hamstring Strength.
Description
A handheld dynamometer will be used to assess hamstring strength.
Time Frame
6 weeks
Title
Hamstring Strength.
Description
A handheld dynamometer will be used to assess hamstring strength.
Time Frame
12 weeks
Title
Aerobic Capacity
Description
The six-minute walk test will be conducted to assess aerobic capacity.
Time Frame
Baseline
Title
Aerobic Capacity
Description
The six-minute walk test will be conducted to assess aerobic capacity.
Time Frame
6 weeks
Title
Aerobic Capacity
Description
The six-minute walk test will be conducted to assess aerobic capacity.
Time Frame
12 weeks
Title
Exercise Compliance
Description
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.
Time Frame
Baseline
Title
Exercise Compliance
Description
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.
Time Frame
6 weeks
Title
Exercise Compliance
Description
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.
Time Frame
12 weeks
Title
Balance
Description
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.
Time Frame
Baseline
Title
Balance
Description
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.
Time Frame
6 weeks
Title
Balance
Description
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.
Time Frame
12 weeks
Title
Postural sway
Description
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.
Time Frame
Baseline
Title
Postural sway
Description
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.
Time Frame
6 weeks
Title
Postural sway
Description
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.
Time Frame
12 weeks
Title
Forward Version of Digit-Span Test
Description
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.
Time Frame
Baseline
Title
Forward Version of Digit-Span Test
Description
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.
Time Frame
6 weeks
Title
Forward Version of Digit-Span Test
Description
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.
Time Frame
12 weeks
Title
Backward Version of Digit-Span Test
Description
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.
Time Frame
Baseline
Title
Backward Version of Digit-Span Test
Description
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.
Time Frame
6 weeks
Title
Backward Version of Digit-Span Test
Description
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.
Time Frame
12 weeks
Title
Executive Function
Description
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.
Time Frame
Baseline
Title
Executive Function
Description
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.
Time Frame
6 weeks
Title
Executive Function
Description
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.
Time Frame
12 weeks
Title
Depression
Description
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.
Time Frame
Baseline
Title
Depression
Description
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.
Time Frame
6 weeks
Title
Depression
Description
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.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clare YU, PhD
Phone
(852)34003251
Email
clare-chung-wah.yu@polyu.edu.hk
First Name & Middle Initial & Last Name or Official Title & Degree
Vangie CHUNG
Phone
(852)27664329
Email
vangie.chung@polyu.edu.hk
Facility Information:
Facility Name
The Hong Kong Polytechnic University
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clare YU, PhD
Phone
(852)34003251
Email
clare-chung-wah.yu@polyu.edu.hk

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data will be available upon request.

Learn more about this trial

Virtual Reality Exercise Program for People With Type 2 Diabetes

We'll reach out to this number within 24 hrs