- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06941506
Using 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 Cognitive Behavioral Impairment and Sensory Perceptual Impairment of Older Adults With Dementia
This project was aimed to examine the effects of a six-month VA exercise program incorporate the SPOZ technology in improving the cognitive behavioral impairment and sensory perceptual impairment of older adults with dementia in adult daycare centers.
Study Overview
Status
Completed
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 cognitive behavioral impairment (using Montreal Cognitive Assessment and Neuropsychiatric Inventory Questionnaire) and sensory perceptual impairment (using Pain Assessment in Advanced Dementia) 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 |
|---|---|
|
Active Comparator: Control
Participants in the control group maintained their routine activities.
|
Participants maintained their routine activities.
|
|
Experimental: VA-SPOZ exercise program
The VA-SPOZ exercise program was comprised of three 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 three 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cognitive status
Time Frame: 6 months
|
measured by the Montreal Cognitive Assessment.
A scale that includes seven aspects: visuospatial and executive functioning, animal naming, delayed recall (short-term memory), attention, language, abstraction, and orientation.
The total score ranges between 0 and 30: a score ≥ 26 indicates no cognitive impairment, 18-25 indicates mild cognitive impairment, 10-17 represents moderate impairment, and < 10 indicates severe impairment.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain status
Time Frame: 6 months
|
measured by the Pain Assessment in Advanced Dementia.
A 5-item scale that includes patient's breathing pattern, uncomfortable/negative vocalization, facial expression, body language, and soothability.
Scores are rated on a scale of 0-2.
The total score is between 0 and 10; a higher score indicates a higher level of observed discomfort.
|
6 months
|
|
Behavioral and psychological symptoms of dementia (BPSD)
Time Frame: 6 months
|
measured by the Neuropsychiatric Inventory Questionnaire.
The 12 items measure 12 psychiatric behavioral symptoms: delusions, hallucinations, agitation/aggression, depression/bad mood, anxiety, euphoria/elation, apathy, vocally disruptive behaviors, irritable/changeable mood, aberrant motor behaviors, sleep/nighttime behaviors, and changes in appetite/eating 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 the total score is 36 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 the total score is 60 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 23, 2025
Primary Completion (Actual)
December 18, 2025
Study Completion (Actual)
December 18, 2025
Study Registration Dates
First Submitted
April 16, 2025
First Submitted That Met QC Criteria
April 16, 2025
First Posted (Actual)
April 23, 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(1)
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.
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