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Recruiting NCT07732530

Acupoint Stimulation and Exercise for Taiwanese Pre-frail Older Adults

No phase Interventional Frailty Sleep Quality Aging

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Vivifrail Exercise Program, Acupoint Stimulation.
Who it may be relevant to
Registry conditions: Frailty, Sleep Quality, Aging. Basic parameters: from 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Behavioral 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.
  • Other 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.

Primary outcome measures

  • Change in Frailty Score [Time frame: Baseline, Week 4, and Week 12]
  • Change in Sleep Quality [Time frame: Baseline, Week 4, and Week 12]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

1\. Individuals who are unwilling or unable to wear an actigraph (wrist monitor) or undergo physical measurements.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

Taiwan · 1 center
  • Tainan Hospital, Ministry of Health and Welfare — Tainan

Identifiers

NCT: NCT07732530 · A-ER-114-105

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗