Acupoint Stimulation and Exercise for Taiwanese Pre-frail Older Adults
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorTainan Hospital, Ministry of Health and Welfare
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Vivifrail Exercise Program
BehavioralA 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 interventionDaily 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.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Exercise Combined with Acupoint StimulationExperimental treatment 2 interventions
Group B: Exercise Training OnlyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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. 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).
Time frame
Baseline, Week 4, and Week 122
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).
Time frame
Baseline, Week 4, and Week 12Sponsors and contacts
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Source ClinicalTrials.gov