Disease and DysfunctionNCT06942832
Integrating SPOZ Technology to Support and Enhance the Vitality Acupunch (VA) Exercise Program for Older Adults With Dementia
A study testing VA-SPOZ exercise program in people with Disease and Dysfunction and Functional Fitness Deterioration, run by Kaohsiung Medical University at 1 site in Taiwan.
Trial summary
This project was aimed to examine the effects of a six-month VA exercise program incorporated the SPOZ technology in improving the disease dysfunction and functional fitness deterioration of older adults with dementia in adult daycare centers. Read more about this study
- Who is it for?
- Ages 65 to 100 years
- Conditions the study is for
- Disease and Dysfunction, Functional Fitness Deterioration, Activities of Daily Living
- What is being tested?
- VA-SPOZ exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteTaiwan
- Study dates
- 24 Apr 2025to 18 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 100 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- diagnosed as dementia by a physician, or
- screened by the SPMSQ as dementia
- age 65 and older
Who cannot join
- have severe cardiopulmonary disease
- have physical mobility impairment
- have spinal cord injury
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Integration of SPOZ Technology to Support and Enhance the Vitality Acupunch Exercise Program for Improving the Disease Dysfunction and Functional Fitness Deterioration of Older Adults With Dementia
This project was aimed to examine the effects of a six-month VA exercise program incorporated the SPOZ technology in improving the disease dysfunction and functional fitness deterioration of older adults with dementia in adult daycare centers.
Read the detailed description
A cluster-randomized controlled trial was conducted to examine the effects of a six-month VA exercise program incorporated the SPOZ technology in improving the disease dysfunction, functional fitness deterioration (balance, lower muscle endurance, gait speed, handgrip strength, cardiorespiratory endurance, muscle endurance, agility, body flexibility), activities of daily living, instrumental activities of daily living, and sleep quality of older adults with dementia in adult daycare centers. Using convenience sampling, 10 adult daycare centers with 142 older adults were recruited, and then cluster-randomized by the daycare centers to an experimental or a control group. The experimental group received a 40-minute program 3 times a week for 6 months; the control group maintained their routine activities. The two groups were measured at three time points: before the intervention, and at three months and six months of the intervention.
- Conditions
- Disease and Dysfunction, Functional Fitness Deterioration, Activities of Daily Living, Instrumental Activities of Daily Living, Sleep Quality
- Being tested
- VA-SPOZ exercise program, Control
- Medical subject headings
- Disease, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VA-SPOZ exercise programOther
The VA-SPOZ exercise program had 3 phases and took 40 minutes to complete. The program was performed in a seated position, and the participants wore SPOZ devices on both hands to record and track the accuracy of the movements.
ControlOther
Participants maintained their routine activities.
| Study group | Role | What they receive |
|---|---|---|
| VA-SPOZ exercise program | Experimental | The VA-SPOZ exercise program was comprised of 3 parts: (1) the first part had 5 movements, including breathing regulation, alternating arm stretching, trunk movement, alternating left and right legs, and gradually started the blood circulation in a gentle way; (2) the second part had 14 movements, using five punching techniques, the left and right arms alternating in a natural parabola, and punching the acupoints to vibrate meridians. The purpose of the second part of the movement was to stimulate the 14 meridians and to promote the circulation of qi and blood throughout the body; (3) the third part had 5 movements, which were to adjust the breath, relax the muscles, stretch the body, and warm the face and lower back of the body by hand touch. Participants wore SPOZ devices on both hands to record and track the accuracy of the movements.The 40-minute program was administered three times a week for 6 months. Receives: Other: VA-SPOZ exercise program |
| Control | Active comparator | Participants in the control group maintained their routine activities. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance
measured by the Balance tests in SPPB
Measured: 6 months
Lower muscle endurance
measured by the 5-time sit-to-stand in SPPB
Measured: 6 months
Gait speed
measured by the 4-m walk in SPPB
Measured: 6 months
Handgrip strength
measured by the Digital Handgrip Dynamometer (TKK-5101)
Measured: 6 months
Cardiorespiratory endurance
measured by the 2-minute step test
Measured: 6 months
Muscle endurance
measured by the SPOZ devices
Measured: 6 months
Agility
measured by the SPOZ devices
Measured: 6 months
Body flexibility
measured by the SPOZ devices
Measured: 6 months
Secondary outcomes (3)
Activities of daily living (ADL)
measured by the Disability Assessment for Dementia (Categories 1-4). The scale has 47 questions measuring 11 types of activities; of which, 22 questions measuring 4 types of ADL. The scoring system (yes = 1, no = 0, and not applicable = N/A) can be divided into three parts: (1) initiation (7 items): measuring the ability to decide or to start an action; (2) planning and organization (8 items): measuring the ability to structure activities in an appropriate sequence and to be able to prepare relevant supplies or develop strategies before action; and (3) performance (7 items): measuring the ability to complete the entire activity. Divide the total score by the number of questions answered (excluding the number of questions that are not applicable), the score converts into a percentage. A higher percentage indicates less disability in daily activities.
Measured: 6 months
Instrumental activities of daily living (IADL)
measured by the Disability Assessment for Dementia (Categories 5-10). The scale has 47 questions measuring 11 types of activities; of which, 22 questions measuring 6 types of IADL. The scoring system (yes = 1, no = 0, and not applicable = N/A) can be divided into three parts: (1) initiation (6 items): measuring the ability to decide or to start an action; (2) planning and organization (6 items): measuring the ability to structure activities in an appropriate sequence and to be able to prepare relevant supplies or develop strategies before action; and (3) performance (10 items): measuring the ability to complete the entire activity. Divide the total score by the number of questions answered (excluding the number of questions that are not applicable), the score converts into a percentage. A higher percentage indicates less disability in daily activities.
Measured: 6 months
Sleep quality
measured by the Neuropsychiatric Inventory Questionnaire (Item 11). The item 11 measures sleep/nighttime behaviors. The assessment consists of three parts: (1) to determine the presence or absence of symptoms, 0 = no, 1 = yes; (2) to determine the severity of the symptoms, rating between 1 and 3, and with higher scores indicate more severe symptoms; (3) to rate the degree of caregiver's distress caused by the client's symptoms on a scale of 0-5, and with higher scores indicating greater distress.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2025
- Study start24 Apr 2025
- Primary completion18 Dec 2025
- Study completion18 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disease and DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaohsiung Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kuei-Min Chen, Ph.D., RN., Kaohsiung Medical University
- Investigators
- Kuei-Min Chen, PhD, Principal investigator, Kaohsiung Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06942832
- Sponsor's protocol ID
- KMUHIRB-F(I)-20240009(2)
- Status last verified
- Dec 2025
- First submitted
- 17 Apr 2025
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Integration of SPOZ Technology to Support and Enhance the Vitality Acupunch Exercise Program for Improving the Disease Dysfunction and Functional Fitness Deterioration of Older Adults With Dementia
- ClinicalTrials.gov ID
- NCT06942832
- Acronym / sponsor ID
- KMUHIRB-F(I)-20240009(2)
- Conditions
- Disease and Dysfunction, Functional Fitness Deterioration, Activities of Daily Living, Instrumental Activities of Daily Living, Sleep Quality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Kaohsiung Medical UniversityUniversity, hospital or other
- Study start
- 24 Apr 2025 (actual)
- Primary completion
- 18 Dec 2025 (actual)
- Study completion
- 18 Dec 2025 (actual)
- First posted
- 24 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project was aimed to examine the effects of a six-month VA exercise program incorporated the SPOZ technology in improving the disease dysfunction and functional fitness deterioration of older adults with dementia in adult daycare centers.
Detailed description
A cluster-randomized controlled trial was conducted to examine the effects of a six-month VA exercise program incorporated the SPOZ technology in improving the disease dysfunction, functional fitness deterioration (balance, lower muscle endurance, gait speed, handgrip strength, cardiorespiratory endurance, muscle endurance, agility, body flexibility), activities of daily living, instrumental activities of daily living, and sleep quality of older adults with dementia in adult daycare centers. Using convenience sampling, 10 adult daycare centers with 142 older adults were recruited, and then cluster-randomized by the daycare centers to an experimental or a control group. The experimental group received a 40-minute program 3 times a week for 6 months; the control group maintained their routine activities. The two groups were measured at three time points: before the intervention, and at three months and six months of the intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VA-SPOZ exercise program | Experimental | Other: VA-SPOZ exercise programThe VA-SPOZ exercise program was comprised of 3 parts: (1) the first part had 5 movements, including breathing regulation, alternating arm stretching, trunk movement, alternating left and right legs, and gradually started the blood circulation in a gentle way; (2) the second part had 14 movements, using five punching techniques, the left and right arms alternating in a natural parabola, and punching the acupoints to vibrate meridians. The purpose of the second part of the movement was to stimulate the 14 meridians and to promote the circulation of qi and blood throughout the body; (3) the third part had 5 movements, which were to adjust the breath, relax the muscles, stretch the body, and warm the face and lower back of the body by hand touch. Participants wore SPOZ devices on both hands to record and track the accuracy of the movements.The 40-minute program was administered three times a week for 6 months. |
| Control | Active comparator | Other: ControlParticipants in the control group maintained their routine activities. |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- diagnosed as dementia by a physician, or
- screened by the SPMSQ as dementia
- age 65 and older
Key exclusion criteria (3 listed)
- have severe cardiopulmonary disease
- have physical mobility impairment
- have spinal cord injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VA-SPOZ exercise programThe VA-SPOZ exercise program had 3 phases and took 40 minutes to complete. The program was performed in a seated position, and the participants wore SPOZ devices on both hands to record and track the accuracy of the movements. | Other | VA-SPOZ exercise program |
| ControlParticipants maintained their routine activities. | Other | Control |
Primary outcome
Balance
Time frame: 6 months
measured by the Balance tests in SPPB
Lower muscle endurance
Time frame: 6 months
measured by the 5-time sit-to-stand in SPPB
Gait speed
Time frame: 6 months
measured by the 4-m walk in SPPB
Handgrip strength
Time frame: 6 months
measured by the Digital Handgrip Dynamometer (TKK-5101)
Cardiorespiratory endurance
Time frame: 6 months
measured by the 2-minute step test
Muscle endurance
Time frame: 6 months
measured by the SPOZ devices
Agility
Time frame: 6 months
measured by the SPOZ devices
Body flexibility
Time frame: 6 months
measured by the SPOZ devices
3 secondary outcomes
Activities of daily living (ADL)
Time frame: 6 months
Instrumental activities of daily living (IADL)
Time frame: 6 months
Sleep quality
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kuei-Min Chen, PhD principal investigator
Kaohsiung Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VA-SPOZ exercise program in people with Disease and Dysfunction and Functional Fitness Deterioration, run by Kaohsiung Medical University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Balance (time frame: 6 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025.