Virtual Reality Exercise Program for People with Type 2 Diabetes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-01

Study Completion Date

2024-12-25

Brief Summary

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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.

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Detailed Description

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Conditions

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Exercise Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

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.

Study Groups

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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.

Group Type EXPERIMENTAL

Immersive Virtual Reality Exercise (IVRE)

Intervention Type OTHER

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

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.

Group Type ACTIVE_COMPARATOR

Home Exercise

Intervention Type OTHER

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

Interventions

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Immersive Virtual Reality Exercise (IVRE)

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

Intervention Type OTHER

Home Exercise

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

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

55 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No