Virtual Reality Exercise Program for People With Type 2 Diabetes

Exercise Therapy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05794009
• Other study ID #: P0036522
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: March 31, 2025

Study information

• Verified date: March 2023
• Source: The Hong Kong Polytechnic University
• Contact: Clare YU, PhD
• Phone: (852)34003251
• Email: clare-chung-wah.yu[@]polyu.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: March 31, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Exercise Therapy

Intervention

Other:
• Immersive Virtual Reality Exercise (IVRE)
The IVRE program will include aerobic exercise, muscle strengthening exercise, balance and flexibility exercise.
• Home Exercise
Aerobic exercise, muscle strengthening exercise, balance and flexibility exercise at home.

Locations

Country	Name	City	State
Hong Kong	The Hong Kong Polytechnic University	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University	Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Glycated Hemoglobin (HbA1C)	HbA1c can be used to evaluate how well-controlled blood sugar has been throughout	6 weeks
Primary	Glycated Hemoglobin (HbA1C)	HbA1c can be used to evaluate how well-controlled blood sugar has been throughout	12 weeks
Secondary	Chair Stand Test	Testing lower body strength	Baseline
Secondary	Chair Stand Test	Testing lower body strength	6 weeks
Secondary	Chair Stand Test	Testing lower body strength	12 weeks
Secondary	Arm Curl Test	Testing upper body strength	Baseline
Secondary	Arm Curl Test	Testing upper body strength	6 weeks
Secondary	Arm Curl Test	Testing upper body strength	12 weeks
Secondary	Chair Sit and Reach Test	Testing lower body flexibility	Baseline
Secondary	Chair Sit and Reach Test	Testing lower body flexibility	6 weeks
Secondary	Chair Sit and Reach Test	Testing lower body flexibility	12 weeks
Secondary	Back Scratch Test	Testing upper body flexibility	Baseline
Secondary	Back Scratch Test	Testing upper body flexibility	6 weeks
Secondary	Back Scratch Test	Testing upper body flexibility	12 weeks
Secondary	8-Foot Up and Go Test	Testing agility	Baseline
Secondary	8-Foot Up and Go Test	Testing agility	6 weeks
Secondary	8-Foot Up and Go Test	Testing agility	12 weeks
Secondary	Quadriceps strength	A handheld dynamometer will be used to assess quadriceps strength.	Baseline
Secondary	Quadriceps strength	A handheld dynamometer will be used to assess quadriceps strength.	6 weeks
Secondary	Quadriceps strength	A handheld dynamometer will be used to assess quadriceps strength.	12 weeks
Secondary	Hamstring Strength.	A handheld dynamometer will be used to assess hamstring strength.	Baseline
Secondary	Hamstring Strength.	A handheld dynamometer will be used to assess hamstring strength.	6 weeks
Secondary	Hamstring Strength.	A handheld dynamometer will be used to assess hamstring strength.	12 weeks
Secondary	Aerobic Capacity	The six-minute walk test will be conducted to assess aerobic capacity.	Baseline
Secondary	Aerobic Capacity	The six-minute walk test will be conducted to assess aerobic capacity.	6 weeks
Secondary	Aerobic Capacity	The six-minute walk test will be conducted to assess aerobic capacity.	12 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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