Integrating SPOZ Technology to Support and Enhance the Vitality Acupunch (VA) Exercise Program for Older Adults With Dementia

Not Applicable

Recruiting

• Conditions: Disease and Dysfunction; Functional Fitness Deterioration; Activities of Daily Living; Instrumental Activities of Daily Living; Sleep Quality

• Registration Number: NCT06942832
• Lead Sponsor: Kaohsiung Medical University

Brief Summary

This project aims to examine the effects of a six-month VA exercise program incorporate 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 will be conducted to examine the effects of a six-month VA exercise program incorporate 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 122 older adults will be recruited, and then cluster-randomized by the daycare centers to an experimental or a control group. The experimental group will receive a 40-minute program 3 times a week for 6 months; the control group will maintain their routine activities. The two groups will be measured at three time points: before the intervention, and at three months and six months of the intervention.

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-17
• Study First Submitted QC: 2025-04-17
• Study Start: 2025-04-24
• Study First Posted: 2025-04-24
• Last Update Submitted: 2025-04-30
• Last Update Posted: 2025-05-04
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 122

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Balance	6 months	measured by the Balance tests in SPPB
Lower muscle endurance	6 months	measured by the 5-time sit-to-stand in SPPB
Gait speed	6 months	measured by the 4-m walk in SPPB
Handgrip strength	6 months	measured by the Digital Handgrip Dynamometer (TKK-5101)
Cardiorespiratory endurance	6 months	measured by the 2-minute step test
Muscle endurance	6 months	measured by the SPOZ devices
Agility	6 months	measured by the SPOZ devices
Body flexibility	6 months	measured by the SPOZ devices

Secondary Outcome Measures

Name	Time	Method
Activities of daily living (ADL)	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.
Instrumental activities of daily living (IADL)	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.
Sleep quality	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.

Trial Locations

Locations (1)

Kaohsiung Medical University; 🇨🇳 Kaohsiung, Taiwan