Virtual Reality Exercise Program for People With Type 2 Diabetes

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.

Study Overview

• Status: Recruiting
• Conditions: Exercise Therapy
• Intervention / Treatment: Other: Immersive Virtual Reality Exercise (IVRE); Other: Home Exercise

• Study Type: Interventional
• Enrollment (Anticipated): 130
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Clare YU, PhD; Phone Number: (852)34003251; Email: clare-chung-wah.yu@polyu.edu.hk
• Study Contact Backup: Name: Vangie CHUNG; Phone Number: (852)27664329; Email: vangie.chung@polyu.edu.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • The Hong Kong Polytechnic University
    • Contact: Clare YU, PhD; Phone Number: (852)34003251; Email: clare-chung-wah.yu@polyu.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Immersive Virtual Reality Exercise (IVRE); The IVRE program will include aerobic exercise, muscle strengthening exercise, balance and flexibility exercise.
Active Comparator: Home Exercise; 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; Aerobic exercise, muscle strengthening exercise, balance and flexibility exercise at home.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The Hong Kong Polytechnic University
• Collaborators: Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Anticipated): March 31, 2025
• Study Completion (Anticipated): March 31, 2025

Study Registration Dates

• First Submitted: March 6, 2023
• First Submitted That Met QC Criteria: March 20, 2023
• First Posted (Actual): March 31, 2023

Study Record Updates

• Last Update Posted (Actual): March 31, 2023
• Last Update Submitted That Met QC Criteria: March 20, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: exercise, diabetes, cognitive function, virtual reality
• Other Study ID Numbers: P0036522

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will be available upon request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No