NCT07230210

Brief Summary

Sarcopenia, characterized by muscle loss and weakness, is a major health issue among older adults and impacts mobility and quality of life. This study addresses the current lack of long-term, technology-assisted support for managing this condition at home. This randomized controlled trial (RCT) will evaluate a 12-week smart-technology-based program for 60 older adults at risk of sarcopenia. Intervention: Participants in the intervention group will receive a technology-assisted program delivered through a Line Bot system. The platform provides personalized exercise training videos, nutrition education, daily reminders, and a point-based logging system to support adherence and monitor engagement. The control group will receive standard clinic-based care. Purpose: The study aims to examine whether the smart technology intervention can improve muscle mass, physical performance, quality of life, and self-management ability among older adults at risk of sarcopenia. Expected Benefit: The digital intervention is anticipated to offer a more effective, accessible, and sustainable approach compared with standard care, providing practical support for preventing muscle decline in community-dwelling older adults

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
31mo left

Started Dec 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress15%
Dec 2025Dec 2028

First Submitted

Initial submission to the registry

November 13, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 17, 2025

Completed
16 days until next milestone

Study Start

First participant enrolled

December 3, 2025

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

December 11, 2025

Status Verified

December 1, 2025

Enrollment Period

3.1 years

First QC Date

November 13, 2025

Last Update Submit

December 4, 2025

Conditions

Keywords

SarcopeniaSmart TechnologyNutrition and Exercise Intervention

Outcome Measures

Primary Outcomes (1)

  • Appendicular Skeletal Muscle Mass (ASM) by Bioelectrical Impedance Analysis (BIA)

    The change in skeletal muscle mass will be assessed using Appendicular Skeletal Muscle Mass (ASM), derived from bioelectrical impedance analysis (BIA). The primary endpoint is the between-group difference in the absolute change in ASM (in kilograms) from baseline to the end of the 12-week intervention (Week 12)

    Baseline (Week 0), Week 8, and Final Assessment at Week 12.

Study Arms (2)

Smart Technology-Assisted Exercise and Nutrition Program

EXPERIMENTAL

Participants in the intervention group (n=30) will receive a 12-week smart technology-assisted combined exercise and nutrition program. The intervention is delivered via a dedicated Line Bot platform, which provides: 1) Three progressive exercise training videos (resistance, aerobic, and balance) , \*\*with the goal of participants completing five exercise sessions per week using the provided materials\*\*. 2) Nutrition education videos focusing on protein intake. 3) Interactive features including daily reminders, protein intake calculation tools, and a digital diary with motivational elements to promote adherence and self-management.

Behavioral: The 12-week exercise component is delivered via the dedicated Line Bot platform. It includes three progressive exercise training videos (resistance, balance) . Participants are in

Standard Outpatient Care

NO INTERVENTION

Participants in the control group (n=30) will receive standard outpatient care for sarcopenia risk management, which includes general health education pamphlets and regular follow-ups at the clinic. They will not receive any specialized exercise training, nutrition videos, or access to the Line Bot platform during the 12-week intervention period.

Interventions

The 12-week progressive exercise program (resistance, aerobic, and balance training) is uniquely delivered and monitored via a dedicated \*\*Line Bot platform\*\*. This differentiates it from traditional in-person or non-interactive video programs. The platform includes interactive features like daily reminders and a digital diary to enhance adherence and support participant self-management, aiming for five exercise sessions per week.

Smart Technology-Assisted Exercise and Nutrition Program

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Score ≥ 11 on the SARC-CalF questionnaire, indicating risk of sarcopenia.
  • No evident functional impairment in the limbs and able to complete handgrip strength, walking speed, and muscle mass assessments.
  • Possesses basic reading, writing, and calculation abilities sufficient to understand study-related materials and complete informed consent and daily logs.
  • Owns a smartphone and has used it for at least one year, with basic operational ability (e.g., sending and receiving LINE messages, scanning QR codes).

You may not qualify if:

  • Self-reported functional impairment in any limb.
  • Requires assistance from a wheelchair, walker, or cane for ambulation.
  • Has an implanted cardiac pacemaker.
  • Currently participating in, or planning to participate in, other physical training courses or nutrition programs during the study period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BuddhistTCGH

Hualien City, 970473, Taiwan

RECRUITING

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Central Study Contacts

Mei Lan Hsiao, RN

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
This study is an open-label randomized controlled trial (RCT) due to the complexity of the Line Bot intervention and the involvement of the same study personnel in both intervention delivery and data collection. Potential sources of bias are minimized through the following procedures: Random Allocation: Group assignment is conducted using sealed, opaque envelopes to ensure unbiased randomization. Objective Primary Outcomes: Primary outcomes such as muscle mass and physical function are assessed using standardized and quantifiable measurement instruments. Standardized Training: All study personnel responsible for data collection follow standardized operating procedures to ensure consistency across both groups.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants are randomized into two parallel arms: the Intervention Group (n=30) and the Control Group (n=30). Both groups will remain in their assigned arm for the entire 12-week study duration.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Master's Student and Geriatric Case Manager

Study Record Dates

First Submitted

November 13, 2025

First Posted

November 17, 2025

Study Start

December 3, 2025

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

December 11, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

IPD will not be shared due to the lack of dedicated infrastructure and resources for data hosting, curation, and the formal management of external data access requests in this small, investigator-initiated study.

Locations