Acupoint Stimulation and Exercise for Taiwanese Pre-frail Older Adults | NCT07732530

NCT07732530

Overview

NCT ID: NCT07732530
Lead Sponsor: Tainan Hospital, Ministry of Health and WelfareOTHER
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
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.
Conditions: Frailty

Status and Timeline

Status: Recruiting
Last Update Posted: Jul 29, 2026Actual
Start Date: Jun 3, 2025Actual
Primary Completion Date: Dec 31, 2027Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
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.

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 30Estimated
Primary Purpose: Prevention
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Contacts and Locations

Central Contacts: Yu-Ching Hsu, MDContact
tnhpcm2017@gmail.com+886-6-2202121

Similar Studies

Participant Group/Arms

Exercise Combined with Acupoint StimulationExperimental

Participants 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).

Behavioral: Vivifrail Exercise Program

Other: Acupoint Stimulation

Exercise Training OnlyActive Comparator

Participants receive the 12-week Vivifrail exercise program and sleep hygiene education, without any acupoint stimulation.

Behavioral: Vivifrail Exercise Program