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NCT Number: NCT07732530

Acupoint Stimulation and Exercise for Taiwanese Pre-frail Older Adults

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.

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Key information

Conditions

Frailty Aging Dyssomnias Mental Disorders Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Quality Sleep Wake Disorders

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tainan Hospital, Ministry of Health and Welfare

Tainan, Taiwan

Location status: Recruiting

Location contact

Yu-Ching Hsu, MD

CONTACT

[email protected]

+886-6-2202121

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Vivifrail Exercise program

Behavioral

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

Other

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 outcomes

  1. Change in Frailty Score

    Time frame: 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).

  2. Change in Sleep Quality

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Yu-Ching Hsu, MD

CONTACT

[email protected]

+886-6-2202121

Sponsors and collaborators

Lead sponsor

Tainan Hospital, Ministry of Health and Welfare

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 29, 2026
Registry last updated
Aug 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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