NCT05021432

Brief Summary

There is a paucity of literature in studying the comparative effects of Virtual Reality and Circuit training in elderly population for fall prevention. This study will also analyze the effects of the comparative intervention on Gait, Balance and Cognition. This will also deduce the impact of Virtual reality and Circuit training on Quality of Life QOL.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

August 3, 2021

Completed
22 days until next milestone

First Posted

Study publicly available on registry

August 25, 2021

Completed
7 days until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

January 26, 2022

Status Verified

January 1, 2022

Enrollment Period

4 months

First QC Date

August 3, 2021

Last Update Submit

January 25, 2022

Conditions

Elderly

Outcome Measures

Primary Outcomes (2)

  • Timed up and go test

    helps to measure the functional ability and to determine the dynamic balance abilities among the elderly. An older adult who takes ≥12 seconds to complete the TUG is at risk for falling. Change from Baseline balance to 8th Weeks

    8th Weeks

  • Dynamic Gait Index

    it helps to measure the functional ability and to determine the dynamic balance and gait abilities. its total score is 24. Change from Baseline balance to 8th Weeks

    8th Weeks

Secondary Outcomes (1)

  • SF-12 scale

    8 Weeks

Study Arms (2)

Virtual Reality Group

EXPERIMENTAL

Virtual Reality group will receive video based games training.

Other: Virtual reality training group

Circuit Training Group

ACTIVE COMPARATOR

They will receive Task-oriented Circuit training exercise program

Other: Circuit Training group

Interventions

Virtual reality training groupOTHER

This group will receive video based games

Virtual Reality Group
Circuit Training groupOTHER

They will receive Task-oriented Circuit training exercise program

Circuit Training Group

Eligibility Criteria

Age60 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 60-75 years
  • Both Gender
  • In past year-accidental fall history of 1-2 times
  • Be identified as being at medium risk for a fall on the initial medical assessment (Berg balance scale 21- 40/56)
  • Score \>19 on SMMSE

You may not qualify if:

  • Declared unfit for physical activities following medical assessment.
  • Present with progressive Neurological disease, Vestibular disease or any comorbidity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pakistan General Railway Hospital

Rawalpindi, Punjab Province, 46000, Pakistan

Location

Related Publications (6)

  • Caixeta GC, Dona F, Gazzola JM. Cognitive processing and body balance in elderly subjects with vestibular dysfunction. Braz J Otorhinolaryngol. 2012 Apr;78(2):87-95. doi: 10.1590/S1808-86942012000200014.

    PMID: 22499375BACKGROUND

  • Moylan KC, Binder EF. Falls in older adults: risk assessment, management and prevention. Am J Med. 2007 Jun;120(6):493.e1-6. doi: 10.1016/j.amjmed.2006.07.022.

    PMID: 17524747BACKGROUND

  • Phu S, Vogrin S, Al Saedi A, Duque G. Balance training using virtual reality improves balance and physical performance in older adults at high risk of falls. Clin Interv Aging. 2019 Aug 28;14:1567-1577. doi: 10.2147/CIA.S220890. eCollection 2019.

    PMID: 31695345BACKGROUND

  • de Vries AW, Faber G, Jonkers I, Van Dieen JH, Verschueren SMP. Virtual reality balance training for elderly: Similar skiing games elicit different challenges in balance training. Gait Posture. 2018 Jan;59:111-116. doi: 10.1016/j.gaitpost.2017.10.006. Epub 2017 Oct 5.

    PMID: 29028622BACKGROUND

  • Pointer S. Trends in hospitalised injury, Australia. Canberra: Australian Institute of Health and Welfare. 2013.

    BACKGROUND

  • Ghous M, Masood Q, Nawaz Malik A, Afridi A, Mehmood Q. Comparison of Nonimmersive Virtual Reality and Task-Oriented Circuit Training on Gait, Balance, and Cognition Among Elderly Population: A Single-Blind Randomized Control Trial. Games Health J. 2024 Jun;13(3):164-171. doi: 10.1089/g4h.2022.0205. Epub 2024 Mar 21.

    PMID: 38512706DERIVED

Study Officials

  • Misbah Ghous, MS

    Riphah International University Islamabad

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2021

First Posted

August 25, 2021

Study Start

September 1, 2021

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

January 26, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)