Acupoint Stimulation and Exercise for Taiwanese Pre-frail Older Adults
Exploring the Associations Among Frailty, Daily Physical Activity, Sleep, and Traditional Chinese Medicine Constitution in Taiwanese Older Adults, and Evaluating the Effects of Acupoint Stimulation Interventions
1 other identifier
interventional
30
1 country
1
Brief Summary
This study aims to explore the relationships between frailty, daily physical activity, sleep quality, and Traditional Chinese Medicine (TCM) constitutions among older adults in Taiwan. In the trial phase, a randomized controlled trial will be conducted specifically for pre-frail older adults. Participants will be randomly assigned to either the exercise training group (Vivifrail program) or the integrated group combining exercise with daytime and sleep-improving acupoint stimulation. The study evaluates the combined efficacy of these non-invasive interventions on reducing frailty severity, improving sleep, and enhancing daily physical functions.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2025
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 3, 2025
CompletedFirst Submitted
Initial submission to the registry
July 23, 2026
CompletedFirst Posted
Study publicly available on registry
July 29, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
July 29, 2026
July 1, 2026
2.6 years
July 23, 2026
July 23, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Change in Frailty Score
Evaluated using the Fried frailty phenotype criteria, which includes five components: unintentional weight loss, weakness (grip strength), exhaustion, slowness (walking speed), and low physical activity.
Baseline, Week 4, and Week 12
Change in Sleep Quality
Measured via the Pittsburgh Sleep Quality Index (PSQI) questionnaire (global score ranges from 0 to 21, where higher scores indicate poorer sleep quality) and objective metrics from the 7-day wrist actigraphy (including total sleep time and sleep efficiency).
Baseline, Week 4, and Week 12
Study Arms (2)
Exercise Combined with Acupoint Stimulation
EXPERIMENTALParticipants receive a 12-week multimodal intervention, including the Vivifrail exercise program (daily, 45-60 minutes) and personalized daytime and sleep acupoint stimulation (2-3 times daily).
Exercise Training Only
ACTIVE COMPARATORParticipants receive the 12-week Vivifrail exercise program and sleep hygiene education, without any acupoint stimulation.
Interventions
A 12-week home-based multimodal exercise program including daily walking, upper limb resistance training, balance exercises, and flexibility training, tailored to pre-frail older adults.
Daily home-based acupoint self-massage (2-3 times per day, 3-5 minutes per point) targeting specific meridians (including Spleen, Stomach, and Bladder meridians) to alleviate fatigue and promote sleep quality.
Eligibility Criteria
You may qualify if:
- Individuals who are capable of undergoing frailty assessments.
- Individuals who possess effective communication skills.
- Aged 50 years or older.
- Willing to provide written informed consent, keep a 7-day sleep diary, and complete related questionnaires.
- Identified as pre-frail (frailty score of 1-2 points) according to the frailty phenotype criteria for the clinical trial phase.
You may not qualify if:
- \. Individuals who are unwilling or unable to wear an actigraph (wrist monitor) or undergo physical measurements.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tainan Hospital, Ministry of Health and Welfare
Tainan, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Attending Physician
Study Record Dates
First Submitted
July 23, 2026
First Posted
July 29, 2026
Study Start
June 3, 2025
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
December 31, 2027
Last Updated
July 29, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will not share