- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07242495
Additional Effects of Immersive vr 360 Degree Videos With Aerobic Exercises on Cognitive Functions in Elderly With Mild Cognitive Impairment
Study Overview
Status
Detailed Description
Mild Cognitive Impairment (MCI) is a transitional stage between normal aging and dementia, characterized by a noticeable decline in cognitive abilities that does not yet significantly interfere with daily functioning. The prevalence of MCI in older adults is estimated to be around 15-20%, and individuals with this condition often face challenges in memory, attention, and executive function. These impairments can reduce independence, limit participation in daily activities, and increase the risk of progression to dementia or Alzheimer's disease. One of the major consequences of cognitive decline is difficulty in maintaining attention and executive control, which are essential for managing everyday tasks such as planning, organizing, and problem-solving. This decline not only affects quality of life but also places a greater burden on caregivers and healthcare systems.
Non-pharmacological interventions have gained increasing attention as pharmacological treatments have shown limited effectiveness in slowing the progression of MCI. Aerobic exercise has long been recognized for its positive effects on both physical and cognitive health, improving blood flow, neuroplasticity, and memory functions. More recently, immersive Virtual Reality (VR) 360-degree videos have emerged as a promising tool for cognitive rehabilitation. VR provides enriched sensory stimulation and engaging environments that can enhance attention, memory, and executive processes by immersing individuals in interactive and stimulating experiences.
This study aims to determine the additional effects of combining immersive VR 360-degree videos with aerobic exercises on cognitive functions in elderly individuals with MCI. By comparing two interventions-VR 360-degree videos with aerobic exercises versus aerobic exercises alone-this research seeks to evaluate whether VR can amplify the cognitive benefits of exercise. The intervention group will undergo a 6-week program consisting of VR 360-degree videos combined with aerobic exercises, starting with 15-minute sessions twice a week and progressing up to 25 minutes. The control group will perform chair-based aerobic exercises of the same duration and frequency without VR.
Key outcome measures, including the Montreal Cognitive Assessment (MoCA) and the Trail Making Test (TMT), will be used to assess global cognition, attention, and executive function. Assessments will be conducted at baseline, mid-point (3rd week), and post-intervention (6th week). Participants will be older adults aged 60 years and above with MoCA scores between 18-25, who are able to perform independent activities of daily living. Eligible participants will be recruited through non-probability convenient sampling and randomly assigned into two groups using the coin toss method.
This single-blinded randomized controlled trial will be conducted at Fauji Foundation Hospital, Rawalpindi, over the course of one year following ethical approval. By exploring the combined effects of VR and aerobic exercise, this study aims to provide valuable insights into innovative, accessible, and engaging interventions that can support cognitive health in older adults with MCI, ultimately improving their quality of life and delaying further cognitive decline.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Zara Amir, DPT
- Phone Number: +92 3498273139
- Email: sp24npt011@fui.edu.pk
Study Locations
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Islamabad, Pakistan, 46000
- Recruiting
- Foundation University College of Physical Therapy
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Contact:
- Kiran Khushnood, MS-NMPT
- Phone Number: +92333-5993417
- Email: kiran.khushnood@fui.edu.pk
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Older population aged from 60years and above
- Normal/ normal to corrected vision
- MoCA Score of 18-25 for screening / MCI patients
- Can do Independent ADLS
Exclusion Criteria:
- Individuals with preexisting conditions such as severe motion sickness that could be exacerbated by VR usage.
- Communication impairments
- Participants with other neurological disorders.
- Sensory deficits (such as uncontrolled hearing or visual issues)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: VR 360 degree Videos and Aerobic Chair Exercises intervention
Intervention: Combination of immersive VR 360° videos and structured chair-based aerobic exercises Session Duration: Starts at 15 minutes, progresses up to 25 minutes Frequency: 2 sessions per week Total Duration: 6 weeks VR Content: Forest, wildlife, space, wildlife, solar system, waterfalls, room environments Aerobic Exercises: Chair-based aerobic exercises (upper and lower limb movements, rhythmic seated marching, arm raises) Additional Task: Short memory recall activity to explain the main events, details and characters in the VR 360 degree video at the end of each VR session |
Combination of immersive VR 360° videos and structured chair-based aerobic exercises Session Duration: Starts at 15 minutes, progresses up to 25 minutes Frequency: 2 sessions per week Total Duration: 6 weeks VR Content: Forest, wildlife, space, wildlife, solar system, waterfalls, room environments Aerobic Exercises: Chair-based aerobic exercises (upper and lower limb movements, arm raises) Additional Task: Short memory recall activity to explain the main events, details and characters in the VR 360 degree video at the end of each VR session. |
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Active Comparator: Chair Aerobic Exercises
Chair aerobic exercises 15 min/day with progression upto 25 min, 2 days a week, for 6 weeks. Chair aerobic exercise includes:
|
Chair aerobic exercises 15 min/day with progression upto 25 min, 2 days a week, for 6 weeks. Chair aerobic exercise includes:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cognitive function
Time Frame: 6 weeks
|
Montreal Cognitive Assessment (MoCA) will be used for this. Values: 26-30 = Normal cognition 18-25 = Mild Cognitive Impairment (MCI) 10-17 = Moderate cognitive impairment <10 = Severe cognitive impairment |
6 weeks
|
|
Attention
Time Frame: 6 weeks
|
Trail Making Test will be used for this. Values: TMT-A: <40 seconds = Above average 40-60 seconds = Average TMT-B: <75 seconds = Above average 75-180 seconds = Average |
6 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FUI/CTR/2025/09
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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