NCT05703568

Brief Summary

The study aims to investigate the efficacy of group-based exercises using virtual reality on activities of daily living in elderly population.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

January 19, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 30, 2023

Completed
11 months until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

September 21, 2023

Status Verified

July 1, 2023

Enrollment Period

1 month

First QC Date

January 19, 2023

Last Update Submit

September 20, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Barthel Index for Activities of Daily Living

    The Barthel Index, measures the extent to which somebody can function independently and has mobility in their activities of daily living (ADL) i.e. feeding, bathing, grooming, dressing, bowel control, bladder control, toileting, chair transfer, ambulation and stair climbing. Total scores range from 0 - 20, with lower scores indicating increased disability.

    8 weeks

Secondary Outcomes (7)

  • Physical Activity Scale for the Elderly

    8 weeks

  • Timed Up and Go (TUG)

    8 weeks

  • Single Leg Stance Test (SLST)

    8 weeks

  • Six minute walk test

    8 weeks

  • Geriatric Depression Scale

    8 weeks

  • +2 more secondary outcomes

Study Arms (3)

Group- based virtual reality training

EXPERIMENTAL

Individuals in this arm will be received intervention protocol of group- based virtual reality training program in which total 16-sessions were given for twice a week for eight weeks for 45-minutes.

Other: virtual reality

Individual virtual reality training

EXPERIMENTAL

Individuals in this arm will be received intervention protocol of individual virtual reality training program in which total 16-sessions were given for twice a week for eight weeks for 45-minutes.

Other: Virtual reality

Control group

NO INTERVENTION

Individuals in this arm will continue their routine daily activities.

Interventions

14 elderly participants receive intervention protocol of group- based virtual reality training program (XBOX Kinect games: Your Shape: Fitness Evolved) in which total 16-sessions were given for twice a week for eight weeks for 45-minutes.

Group- based virtual reality training

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Participants who are 65 age or older
  • can ambulate independently

You may not qualify if:

  • elderly individuals who are suffering from any acute or unstable illness or medical condition
  • elderly individuals who are unable to understand the treatment protocol.
  • elderly individuals who are suffering from any kind of visual, auditory and neural or vestibular system disorders.
  • History of surgery in the last 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Osmangazi University

Eskişehir, 26040, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Each participant will be requested to draw either number one, number two or number three from a box. Number one will be allocated to group 1, number two will be allocated o group 2 and number two will be allocated o group 3. The group 1 consists of 14 elderly participants who received intervention protocol of group- based virtual reality training program in which total 16-sessions were given for twice a week for eight weeks for 45-minutes. The group 2 consists of 14 elderly participants who received intervention protocol of individual virtual reality training in which total 16-sessions were given for twice a week for eight weeks for 45-minutes. The group 3 consists of 14 elderly participants will continue their routine daily activities.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

January 19, 2023

First Posted

January 30, 2023

Study Start

January 1, 2024

Primary Completion

February 1, 2024

Study Completion

June 1, 2024

Last Updated

September 21, 2023

Record last verified: 2023-07

Locations