NCT06941506

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
142

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 16, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 23, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

April 23, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 18, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 18, 2025

Completed
Last Updated

December 24, 2025

Status Verified

December 1, 2025

Enrollment Period

8 months

First QC Date

April 16, 2025

Last Update Submit

December 18, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Cognitive status

    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 Outcomes (2)

  • Behavioral and psychological symptoms of dementia (BPSD)

    6 months

  • Pain status

    6 months

Study Arms (2)

VA-SPOZ exercise program

EXPERIMENTAL

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.

Other: VA-SPOZ exercise program

Control

ACTIVE COMPARATOR

Participants in the control group maintained their routine activities.

Other: Control

Interventions

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.

VA-SPOZ exercise program
ControlOTHER

Participants maintained their routine activities.

Control

Eligibility Criteria

Age65 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • diagnosed as dementia by a physician, or
  • screened by the SPMSQ as dementia
  • age 65 and older

You may not qualify if:

  • have severe cardiopulmonary disease
  • have physical mobility impairment
  • have spinal cord injury

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Medical University

Kaohsiung, Taiwan, 80708, Taiwan

Location

Study Officials

  • Kuei-Min Chen, PhD

    Kaohsiung Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 16, 2025

First Posted

April 23, 2025

Study Start

April 23, 2025

Primary Completion

December 18, 2025

Study Completion

December 18, 2025

Last Updated

December 24, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations