Clinical trial NCT06216236: Effects of Physical Fitness Using a Kinect Interventional System
Official title: Effects of Physical Fitness Using a Kinect Interventional System for Pre-frail Community-dwelling Elderly Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Virtual Reality
Physical Fitness
Keywords: Physical fitness
Community dwelling elderly
Virtual reality
Frailty
Lead sponsor: Kaohsiung Veterans General Hospital.
Sponsor class: OTHER
Collaborators: name: National Cheng Kung University
name: Kaohsiung Veterans General Hospital.
First posted: 2024-01-22
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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

Detailed 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 \&#34;yes\&#34; 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\&#39; exercise ability and cyclic tasks as the training design. The VR training content can record the individual\&#39;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\&#39; 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.

Eligibility criteria: Inclusion Criteria:

* (1) individuals \&gt;60 years old who live in the community; (2) use of the SOF scale for frailty to evaluate the three assessments, any one of which satisfy the \&#34;pre-frailty\&#34; criteria; (3) able to walk independently for 5 minutes, regardless if they need a walking aid; and (4) medication usage has been stable in the past month.

Exclusion Criteria:

* (1) those with psychiatric diseases or comorbidities based on the DSM-IV criteria and had psychiatric comorbidities (e.g., major depressive disorder); (2) clinically diagnoses of dementia (dementia) or other severe cognitive impairments (Mini-Mental State Examination score \&lt;24 points); and (3) other neurological, orthopedic, and unstable diseases.

Primary outcomes:
measure: The body mass index (BMI)
timeFrame: 30 min/session 3 sessions/week for 8 weeks.
measure: waist-to-hip ratio (WHR)
timeFrame: 30 min/session 3 sessions/week for 8 weeks.
measure: chair stand test
timeFrame: 30 min/session 3 sessions/week for 8 weeks.
measure: grip strength measurement
timeFrame: 30 min/session 3 sessions/week for 8 weeks.
measure: 6-minute walk (6MWT) tests
timeFrame: 30 min/session 3 sessions/week for 8 weeks.
Secondary outcomes:
measure: The Quality of Life Questionnaire by World Health Organization .
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Veterans General Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University
Study officials:
affiliation: Kaohsiung Veterans General Hospital.
name: Shin-Tsu mr Chang, PhD
role: STUDY_CHAIR
References: