Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06216236 |
| Other study ID # |
KaohsiungVGH |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2020 |
| Est. completion date |
October 31, 2023 |
Study information
| Verified date |
January 2024 |
| Source |
Kaohsiung Veterans General Hospital. |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The Kinect intervention system combined with aerobic exercise training can improve the
quality of life of older adults in the community, standardize behavior regulation in exercise
and improve fitness enthusiasm.
Aerobic exercise training using the Kinect intervention system was more effective than
traditional training
Description:
3.3.1 Participants The subjects of this study are the elderly from the community care center
in Kaohsiung City. Our goal is to recruit two groups with 30 subjects in each group, making
it a total of 60 subjects. The recruitment method of this study is to upload poster
advertisements in the community and the bulletin board of Kaohsiung Veterans General Hospital
to recruit subjects. The purpose is to select those who meet the criteria and agree to
participate in the research. Eligible subjects must sign a human experiment consent form
approved by the Human Experiment Committee of Kaohsiung Veterans General Hospital.
Recruitment of subjects must meet the following standard conditions: (1) elders over the age
of 65 living in the community; (2) those who use the frailty SOF scale to evaluate any of the
three assessments, with the answer being "yes" for any of them (pre frailty) (given
in Appendix 1); (3) able to walk independently for five minutes regardless of mobility aids;
(4) drug stability in the past one month.
The exclusion criteria is as follows: (1) Those who meet the DSM-IV criteria and have
psychiatric comorbidities (for example, major depression); (2) Clinically diagnosed with
dementia (Dementia) or other severe cognitive impairment (mini mental state examination score
less than 24 points); (3) history of stroke, traumatic brain injury or other neurological
disease; (4) acute lower extremity or lower back pain, peripheral neuropathy, rheumatic- and
orthopedic-related diseases; (5) unstable diseases and symptoms in the past six months,
including cardiovascular disease and high blood pressure and/or diabetes; (6) those who
cannot follow the exercise program or participate in other exercise programs at the same
time.
All subjects who meet the inclusion conditions first fill in the general information
assessment that includes basic personal characteristics, disease history, and related
exercise habits. This is used to collect demographic data (depicted in Appendix 2) and fill
in the Chinese version of the quality-of-life questionnaire, exercise behavior Conditioning
Questionnaire, Pap Scale, Instrumental Activities of Daily Living Functioning Scale, and
Mini-Mental State Test. The subject is said to have completed part of the test if they are
unable to continue the remaining items due to physical and/or other factors. At this time,
the subject will make an appointment to do the remaining items next time. All quizzes are
expected to take approximately 40 minutes.
This study was a double-blind random assignment experiment, and the subjects and evaluators
were unaware of the subjecs group. The subjects were randomly assigned to the intervention
group (aerobic dance or aerobic exercise training in virtual reality), and they were asked to
follow the virtual reality program to perform the requisite training. They could see whether
their actions and those of other companions are correct.
The screen displays the percentage of correct movements. The time of each movement is five
minutes with a 2-minute break in between for a total of 30 minutes, three times a week, for
eight weeks, i.e., a total of 24 rounds. The heartbeat was monitored throughout. The control
group did aerobic dance and exercise training without virtual reality. Exercise-related
health education was also given, and changes in the physical functionality of the elderly
living in the community were observed.
3.3.2 Intervention Aerobic dance: According to the demonstration video of the aerobic
teacher, the initial training content combines basic movements with different purposes. The
content is divided into 3METs, 4METs, 5METs, muscle strength training, and relaxation and
stretching activity videos according to exercise intensity. Warm-up training must be done
first followed by simple exercise intensity. After the task is over, a 5-minute rest is taken
before entering higher-intensity task training, muscle strength training, and, finally,
relaxation activities, for a total of 30 minutes.
Integrated movement training: For aerobic movement, basic activity introduction and basic
movement explanation, as well as execution movement, will be analyzed by the software to find
the exact ratio of movement, pulse rate, SpO2, and calories, in order to understand the basic
movement training.
Circulation training: Cardiopulmonary function training uses different individuals'
exercise ability and cyclic tasks as the training design. The VR training content can record
the individual's usage records and exercise intensity, and perform cyclic training for
individual cases, adding repetitive exercises and stimulation.
All interventions will be delivered by trained therapists, three times a week for eight
weeks, with each session lasting approximately 30 minutes. Before the intervention, all
subjects were screened using the Physical Activity Readiness Questionnaire (PAR-Q), and
static blood pressure was checked. Those whose blood pressure was higher than 160/90 mm Hg
were advised to stop the experiment. After the intervention, the subjects' breathing,
heartbeat, and blood pressure were recorded to understand their physiological condition and
gauge the action to be taken next. This could also involve performing primary and secondary
assessment items such as physical fitness, Berg balance scale, standing time on one foot,
activities of daily living,and quality of life before, immediately after, and one month after
the intervention to verify the use of virtual reality aerobic dance effects of an aerobic
exercise training intervention in the changes they cause in physical functionality of
community-dwelling older adults.
