NCT07242495

Brief Summary

One of the key challenges faced by individuals with Mild Cognitive Impairment (MCI) is the decline in cognitive abilities, particularly global cognition, attention, and executive function, which are essential for maintaining independence and performing daily activities. Impaired cognition can significantly reduce quality of life in older adults, leading to difficulties in managing routine tasks, reduced social engagement, and increased dependency on caregivers. Common signs and symptoms include forgetfulness, difficulty concentrating, slower problem-solving, and challenges in planning or organizing daily activities. This study aims to explore and compare the effectiveness of two interventions-immersive Virtual Reality (VR) 360-degree videos combined with aerobic exercises, and aerobic exercises alone-in improving cognitive functions in older adults with MCI. Key outcome measures, including the Montreal Cognitive Assessment (MoCA) and Trail Making Test (TMT), will evaluate the effectiveness of the interventions on global cognition, attention, and executive function. We will include older adults aged 60 years and above with MoCA scores between 18-25 (MCI patients), who are able to perform independent ADLs. The participants will be assessed at the start of the intervention through the MoCA scale for MCI screening and baseline TMT testing for inclusion.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 14, 2024

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

November 17, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 21, 2025

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2026

Completed
Last Updated

November 21, 2025

Status Verified

November 1, 2025

Enrollment Period

1.2 years

First QC Date

November 17, 2025

Last Update Submit

November 17, 2025

Conditions

Keywords

Cognitive rehabilitationVirtual RealityMild cognitive ImpairmentElderlyAerobic exercise

Outcome Measures

Primary Outcomes (2)

  • Cognitive function

    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

    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

Study Arms (2)

VR 360 degree Videos and Aerobic Chair Exercises intervention

EXPERIMENTAL

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

Procedure: VR 360 degree Videos and Aerobic Chair Exercises intervention

Chair Aerobic Exercises

ACTIVE COMPARATOR

Chair aerobic exercises 15 min/day with progression upto 25 min, 2 days a week, for 6 weeks. Chair aerobic exercise includes: 1. Alternate heel digs with bilateral biceps curl 8 repetitions per session. 2. V- Step with bilateral hammer curls 8 repetitions per session. 3. Lateral step touch with bilateral biceps curls 8 repetitions per session. 4. Knee lift 8 repetitions per session. 5. Arm swings 8 repetitions per session. 6. Clap swing 8 repetitions per session. 7. Sit, stand and clap 8 repetitions per session

Procedure: Chair Aerobic Exercises

Interventions

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.

VR 360 degree Videos and Aerobic Chair Exercises intervention

Chair aerobic exercises 15 min/day with progression upto 25 min, 2 days a week, for 6 weeks. Chair aerobic exercise includes: 1. Alternate heel digs with bilateral biceps curl 8 repetitions per session. 2. V- Step with bilateral hammer curls 8 repetitions per session. 3. Lateral step touch with bilateral biceps curls 8 repetitions per session. 4. Knee lift 8 repetitions per session. 5. Arm swings 8 repetitions per session. 6. Clap swing 8 repetitions per session. 7. Sit, stand and clap 8 repetitions per session

Chair Aerobic Exercises

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foundation University College of Physical Therapy

Islamabad, 46000, Pakistan

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2025

First Posted

November 21, 2025

Study Start

September 14, 2024

Primary Completion

December 10, 2025

Study Completion

January 10, 2026

Last Updated

November 21, 2025

Record last verified: 2025-11

Locations