Vivifrail Exercise Program: 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.
Acupoint Stimulation: 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.
Study 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.
Eligibility
Sex
ALL
Min age
50 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Individuals who are capable of undergoing frailty assessments.
2. Individuals who possess effective communication skills.
3. Aged 50 years or older.
4. Willing to provide written informed consent, keep a 7-day sleep diary, and complete related questionnaires.
5. Identified as pre-frail (frailty score of 1-2 points) according to the frailty phenotype criteria for the clinical trial phase.
Exclusion Criteria:
1\. Individuals who are unwilling or unable to wear an actigraph (wrist monitor) or undergo physical measurements.
Primary outcome measure(s)
Change in Frailty Score — Baseline, Week 4, and Week 12 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. Each component is scored as 0 or 1, resulting in a total score ranging from 0 to 5. Higher scores indicate a worse outcome (higher severity of frailty).
Change in Sleep Quality — Baseline, Week 4, and Week 12 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).
Trial sites (1)
Facility
City
Region
Status
Tainan Hospital, Ministry of Health and Welfare
Tainan
Taiwan
Recruiting
More Tainan Hospital, Ministry of Health and Welfare trials in Taiwan
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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