Clinical trial NCT05794009: 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
Overall status: COMPLETED
Phase: NA
Conditions: Exercise Therapy
Keywords: exercise, diabetes, cognitive function, virtual reality
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
Collaborators: name: Chinese University of Hong Kong
First posted: 2023-03-31
Enrollment: 124
Sex: ALL
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Glycated Hemoglobin (HbA1C)
timeFrame: Baseline
measure: Glycated Hemoglobin (HbA1C)
timeFrame: 6 weeks
measure: Glycated Hemoglobin (HbA1C)
timeFrame: 12 weeks
Secondary outcomes:
measure: Chair Stand Test
timeFrame: Baseline
measure: Chair Stand Test
timeFrame: 6 weeks
measure: Chair Stand Test
timeFrame: 12 weeks
measure: Arm Curl Test
timeFrame: Baseline
measure: Arm Curl Test
timeFrame: 6 weeks
measure: Arm Curl Test
timeFrame: 12 weeks
measure: Chair Sit and Reach Test
timeFrame: Baseline
measure: Chair Sit and Reach Test
timeFrame: 6 weeks
measure: Chair Sit and Reach Test
timeFrame: 12 weeks
measure: Back Scratch Test
timeFrame: Baseline
measure: Back Scratch Test
timeFrame: 6 weeks
measure: Back Scratch Test
timeFrame: 12 weeks
measure: 8-Foot Up and Go Test
timeFrame: Baseline
measure: 8-Foot Up and Go Test
timeFrame: 6 weeks
measure: 8-Foot Up and Go Test
timeFrame: 12 weeks
measure: Quadriceps strength
timeFrame: Baseline
measure: Quadriceps strength
timeFrame: 6 weeks
measure: Quadriceps strength
timeFrame: 12 weeks
measure: Hamstring Strength.
timeFrame: Baseline
measure: Hamstring Strength.
timeFrame: 6 weeks
measure: Hamstring Strength.
timeFrame: 12 weeks
measure: Aerobic Capacity
timeFrame: Baseline
measure: Aerobic Capacity
timeFrame: 6 weeks
measure: Aerobic Capacity
timeFrame: 12 weeks
measure: Exercise Compliance
timeFrame: Baseline
measure: Exercise Compliance
timeFrame: 6 weeks
measure: Exercise Compliance
timeFrame: 12 weeks
measure: Balance
timeFrame: Baseline
measure: Balance
timeFrame: 6 weeks
measure: Balance
timeFrame: 12 weeks
measure: Postural sway
timeFrame: Baseline
measure: Postural sway
timeFrame: 6 weeks
measure: Postural sway
timeFrame: 12 weeks
measure: Forward Version of Digit-Span Test
timeFrame: Baseline
measure: Forward Version of Digit-Span Test
timeFrame: 6 weeks
measure: Forward Version of Digit-Span Test
timeFrame: 12 weeks
measure: Backward Version of Digit-Span Test
timeFrame: Baseline
measure: Backward Version of Digit-Span Test
timeFrame: 6 weeks
measure: Backward Version of Digit-Span Test
timeFrame: 12 weeks
measure: Executive Function
timeFrame: Baseline
measure: Executive Function
timeFrame: 6 weeks
measure: Executive Function
timeFrame: 12 weeks
measure: Depression
timeFrame: Baseline
measure: Depression
timeFrame: 6 weeks
measure: Depression
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Hong Kong Polytechnic University
Study officials:
References: