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Clinical Trials/NCT05794009
NCT05794009
Completed
N/A

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

The Hong Kong Polytechnic University1 site in 1 country124 target enrollmentJune 1, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Exercise Therapy
Sponsor
The Hong Kong Polytechnic University
Enrollment
124
Locations
1
Primary Endpoint
Glycated Hemoglobin (HbA1C)
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2022
End Date
December 25, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dr YU Clare Chung Wah

Assistant Professor

The Hong Kong Polytechnic University

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.

Outcomes

Primary Outcomes

Glycated Hemoglobin (HbA1C)

Time Frame: 12 weeks

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

Secondary Outcomes

  • Postural sway(12 weeks)
  • Arm Curl Test(12 weeks)
  • Chair Sit and Reach Test(12 weeks)
  • Executive Function(12 weeks)
  • Chair Stand Test(12 weeks)
  • Back Scratch Test(12 weeks)
  • 8-Foot Up and Go Test(12 weeks)
  • Quadriceps strength(12 weeks)
  • Hamstring Strength.(12 weeks)
  • Aerobic Capacity(12 weeks)
  • Forward Version of Digit-Span Test(12 weeks)
  • Depression(12 weeks)
  • Balance(12 weeks)
  • Backward Version of Digit-Span Test(12 weeks)
  • Exercise Compliance(12 weeks)

Study Sites (1)

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