Virtual Reality Exercise Program for People with Type 2 Diabetes

NCT05794009 | Completed

• 1 other identifier: P0036522
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

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.

Conditions

Exercise Therapy

Keywords

exercise, diabetes, cognitive function, virtual reality

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (45)

• Chair Stand Test

  Baseline

• Chair Stand Test

  6 weeks

• Chair Stand Test

  12 weeks

• Arm Curl Test

  Baseline

• Arm Curl Test

  6 weeks

Study Arms (2)

Immersive Virtual Reality Exercise (IVRE)

EXPERIMENTAL

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)

Home Exercise

ACTIVE COMPARATOR

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

Interventions

Immersive Virtual Reality Exercise (IVRE) OTHER

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

Immersive Virtual Reality Exercise (IVRE)

Home Exercise OTHER

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

Home Exercise

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead
• Chinese University of Hong Kong: collaborator

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Motor Activity; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Behavior; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: March 6, 2023
• First Posted: March 31, 2023
• Study Start: June 1, 2022
• Primary Completion: December 25, 2024
• Study Completion: December 25, 2024
• Last Updated: March 13, 2025

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)