- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05565963
Effectiveness of VR Exercise Intervention on Functional Fitness and Quality of Life Among Elderly
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Taipei, Taiwan, 106
- NTNU
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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).
Exclusion Criteria:
- being less than 65 years of age,
- being unfit to participate in the study as revealed by the PAR-Q.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention group.
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.
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The experimental group received VR exercise sessions for 75-90 minutes, twice a week for a duration of 12 weeks.
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No Intervention: Control group.
No intervention with a 12 week follow-up.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Senior Fitness Test to specify that "a period change" is being assessed.
Time Frame: The time points for assessment were week 1 (pre-test), 13 (post-test), and 24 (follow-up).
|
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).
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Quality of Life Test to specify that "a period change" is being assessed.
Time Frame: Measured at week 1 (pre-test), 13 (post-test), and 24 (follow-up).
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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).
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body mass index (BMI)
Time Frame: Measured at week 1(pre-test).
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Measure older adults of height by attaching cloth ruler tape to the wall (units of measurement: cm).
The weight of the elderly is measured using commercially available electronic weighing machines.
(weight and height will be combined to report BMI in kg/m2).
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Measured at week 1(pre-test).
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International Physical Activity Questionnaire (IPAQ-LV).
Time Frame: Measured at week 1(pre-test).
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Physical activity was chosen through the Taiwanese version of the IPAQ-LV.
Results were determined by first understanding how much total time was spent on physical activity.
This was then multiplied by the frequency of the activity (i.e., per week and per day).
The purpose of this was to evaluate the difference in physical activity of participants.
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Measured at week 1(pre-test).
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Collaborators and Investigators
Investigators
- Study Director: Szu-Hsien Lee, Research Ethics Committee, National Taiwan University, Taiwan
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Other Study ID Numbers
- litingwang_2
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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