NCT05565963

Brief Summary

The aim of this study is to determine the effect of virtual reality-based exercise on the intervention and follow-up retention of functional fitness and quality of life among older adults.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
98

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2020

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 20, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 27, 2021

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2021

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 23, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 4, 2022

Completed
Last Updated

October 4, 2022

Status Verified

September 1, 2022

Enrollment Period

6 months

First QC Date

September 23, 2022

Last Update Submit

October 3, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • Senior Fitness Test to specify that "a period change" is being assessed.

    Senior Fitness Tests were to evaluate the functional fitness of older adults. The test has six items: back scratch (cm), chair sit-and-reach (cm), arm curl, chair stand (times), 2-minute step (times), and 8-foot starting distance (sec). The functional fitness (e.g., back scratch, chair-and-reach, arm curl, chair stand, 2-minute step) of higher scores means better functional fitness. The functional fitness (e.g., 8-foot starting distance) of higher scores means poorer functional fitness. This study is a measure to assess change between two-time points. (1)Change in functional fitness of older adults from 1-week baseline (pre-test) to 12 weeks (i.e., exercise intervention phase). (2) Discontinuation of exercise intervention at 13 (post-test) to 24 weeks (follow-up) and ongoing follow-up of older people's function fitness maintenance outcomes.

    The time points for assessment were week 1 (pre-test), 13 (post-test), and 24 (follow-up).

  • Quality of Life Test to specify that "a period change" is being assessed.

    The WHOQOL-OLD is used to measure the quality of life of older adults. This questionnaire is comprised of 24 items divided into six domains, with each domain having four items. These domains include sensory abilities, autonomy, response to the past present, and future activities, social participation, response to death and dying, and response to intimacy. Responses were rated on a Likert scale, with a 1-5-point scale for each item. The result with the highest total score indicates a greater quality of life. This study is a measure to assess changes between two-time points. (1) Change in self-perceived quality of life from 1-week baseline (pre-test) to 12 weeks (i.e., exercise intervention phase). (2) Discontinuation of exercise intervention at 13 (post-test) to 24 weeks (follow-up) and ongoing follow-up of older people's self-perceived quality of life maintenance outcomes.

    Measured at week 1 (pre-test), 13 (post-test), and 24 (follow-up).

Secondary Outcomes (2)

  • Body mass index (BMI)

    Measured at week 1(pre-test).

  • International Physical Activity Questionnaire (IPAQ-LV).

    Measured at week 1(pre-test).

Study Arms (2)

Intervention group.

EXPERIMENTAL

12-week intervention, with a 12-week follow-up. Device:1 computer virtual reality online software and 3 large projectors were used to project videos on the wall in a wrap-around state.

Other: Virtual reality exercise intervention

Control group.

NO INTERVENTION

No intervention with a 12 week follow-up.

Interventions

The experimental group received VR exercise sessions for 75-90 minutes, twice a week for a duration of 12 weeks.

Intervention group.

Eligibility Criteria

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

You may qualify if:

  • aged ≥ 65,
  • are able to perform daily activities,
  • with no past or current history of medical situations found in the Physical Activity Readiness Questionnaire (PAR-Q).

You may not qualify if:

  • being less than 65 years of age,
  • being unfit to participate in the study as revealed by the PAR-Q.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NTNU

Taipei, 106, Taiwan

Location

Study Officials

  • Szu-Hsien Lee

    Research Ethics Committee, National Taiwan University, Taiwan

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

September 23, 2022

First Posted

October 4, 2022

Study Start

September 20, 2020

Primary Completion

March 27, 2021

Study Completion

March 30, 2021

Last Updated

October 4, 2022

Record last verified: 2022-09

Locations