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Virtual Reality Exercise Program for People with Type 2 Diabetes

Not Applicable
Completed
Conditions
Exercise Therapy
Interventions
Other: Home Exercise
Other: Immersive Virtual Reality Exercise (IVRE)
Registration Number
NCT05794009
Lead Sponsor
The Hong Kong Polytechnic University
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
124
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Home ExerciseHome 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.
Immersive Virtual Reality Exercise (IVRE)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.
Primary Outcome Measures
NameTimeMethod
Glycated Hemoglobin (HbA1C)12 weeks

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

Secondary Outcome Measures
NameTimeMethod
Arm Curl Test12 weeks

Testing upper body strength

Back Scratch Test12 weeks

Testing upper body flexibility

8-Foot Up and Go Test12 weeks

Testing agility

Postural sway12 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.

Chair Sit and Reach Test12 weeks

Testing lower body flexibility

Executive Function12 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.

Chair Stand Test12 weeks

Testing lower body strength

Quadriceps strength12 weeks

A handheld dynamometer will be used to assess quadriceps strength.

Hamstring Strength.12 weeks

A handheld dynamometer will be used to assess hamstring strength.

Aerobic Capacity12 weeks

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

Forward Version of Digit-Span Test12 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.

Depression12 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.

Balance12 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.

Backward Version of Digit-Span Test12 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.

Exercise Compliance12 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.

Trial Locations

Locations (1)

The Hong Kong Polytechnic University

🇭🇰

Hong Kong, Hong Kong

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