- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06942832
Integrating SPOZ Technology to Support and Enhance the Vitality Acupunch (VA) Exercise Program for Older Adults With Dementia
December 18, 2025 updated by: Kuei-Min Chen, Ph.D., RN., Kaohsiung Medical University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
142
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Taiwan
-
Kaohsiung, Taiwan, Taiwan, 80708
- Kaohsiung Medical University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- diagnosed as dementia by a physician, or
- screened by the SPMSQ as dementia
- age 65 and older
Exclusion Criteria:
- have severe cardiopulmonary disease
- have physical mobility impairment
- have spinal cord injury
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: VA-SPOZ exercise program
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.
|
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.
|
|
Active Comparator: Control
Participants in the control group maintained their routine activities.
|
Participants maintained their routine activities.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Balance
Time Frame: 6 months
|
measured by the Balance tests in SPPB
|
6 months
|
|
Lower muscle endurance
Time Frame: 6 months
|
measured by the 5-time sit-to-stand in SPPB
|
6 months
|
|
Gait speed
Time Frame: 6 months
|
measured by the 4-m walk in SPPB
|
6 months
|
|
Handgrip strength
Time Frame: 6 months
|
measured by the Digital Handgrip Dynamometer (TKK-5101)
|
6 months
|
|
Cardiorespiratory endurance
Time Frame: 6 months
|
measured by the 2-minute step test
|
6 months
|
|
Muscle endurance
Time Frame: 6 months
|
measured by the SPOZ devices
|
6 months
|
|
Agility
Time Frame: 6 months
|
measured by the SPOZ devices
|
6 months
|
|
Body flexibility
Time Frame: 6 months
|
measured by the SPOZ devices
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Activities of daily living (ADL)
Time Frame: 6 months
|
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.
|
6 months
|
|
Instrumental activities of daily living (IADL)
Time Frame: 6 months
|
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.
|
6 months
|
|
Sleep quality
Time Frame: 6 months
|
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.
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kuei-Min Chen, PhD, Kaohsiung Medical University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 24, 2025
Primary Completion (Actual)
December 18, 2025
Study Completion (Actual)
December 18, 2025
Study Registration Dates
First Submitted
April 17, 2025
First Submitted That Met QC Criteria
April 17, 2025
First Posted (Actual)
April 24, 2025
Study Record Updates
Last Update Posted (Actual)
December 24, 2025
Last Update Submitted That Met QC Criteria
December 18, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KMUHIRB-F(I)-20240009(2)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
Clinical Trials on Sleep Quality
-
PrecisionBiotics Group Ltd.Nottingham Trent University; Atlantia Food Clinical Trials Ltd.CompletedSubjective Sleep Quality | Objective Sleep QualityIreland
-
Brain Electrophysiology Laboratory CompanyRecruiting
-
University GhentEuropean CommissionCompleted
-
Northumbria UniversityCompletedSleep | Mood | Poor Quality Sleep | Good Sleep HabitUnited Kingdom
-
Nutrition Institute, SloveniaValens Int. d.o.o., Slovenija; Faculty of Pharmacy, University of Ljubljana... and other collaboratorsRecruitingSleep Quality | Sleep Onset LatencySlovenia
-
Bezmialem Vakif UniversityNot yet recruiting
-
West Virginia UniversityCompletedSleep QualityUnited States
-
Osmaniye Korkut Ata UniversityNot yet recruiting
-
West Virginia UniversityCompletedSleep QualityUnited States
-
West Virginia UniversityCompletedSleep QualityUnited States
Clinical Trials on VA-SPOZ exercise program
-
Kaohsiung Medical UniversityCompletedCognitive and Behavioral Impairment | Sensory and Perceptual ImpairmentTaiwan
-
Kaohsiung Medical UniversityCompletedSleep Quality | Muscle Strength | Muscle MassTaiwan
-
Kaohsiung Medical UniversityCompletedActivities of Daily Living | Functional FitnessTaiwan
-
VA Office of Research and DevelopmentCompletedColorectal NeoplasmsUnited States
-
VA Office of Research and DevelopmentRecruitingAnger | PTSD | TBI | Veterans | Suicide Prevention | TransdiagnosticUnited States
-
Azienda Sanitaria Locale CN1 CuneoRecruiting
-
VA Office of Research and DevelopmentProvidence VA Medical CenterCompletedBipolar Disorder | Substance Use DisordersUnited States
-
Kafrelsheikh UniversityRecruitingLow Back Pain | Pilates Exercises | Nonspecific | Postnatal WomenEgypt
-
Hull University Teaching Hospitals NHS TrustTerminated
-
University of Vic - Central University of CataloniaCol·legi Fisioterapeutes de CatalunyaNot yet recruitingBreast Cancer | Physical Activity | Colorectal Cancer | Strength and Endurance | Lung Cancer (Non-Small Cell) | Neoadjuvant Chemotherapy ToleranceSpain