NCT07345832

Brief Summary

Sarcopenia prevention and management are highly prioritised goals in the Healthy Ageing agenda. The study aims to: 1) evaluate the effects of the digital-enhanced, volunteer-engaged collaborative care pathway to improve sarcopenia, reduce fall risk, and increase health-related quality of life (HRQL) among community-dwelling older adults with risk of, or diagnosed with, sarcopenia; 2) evaluate whether the volunteers who received health coach capacity training and supported the intervention experienced health benefits across time; 3) explore the engagement experiences and perceived effects of elderly participants with sarcopenia during the program; 4) evaluate the intervention implementation process and effects from the perspectives of social care workers.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
16mo left

Started Jun 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress3%
Jun 2026Sep 2027

First Submitted

Initial submission to the registry

January 7, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 16, 2026

Completed
5 months until next milestone

Study Start

First participant enrolled

June 1, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2027

Last Updated

May 7, 2026

Status Verified

March 1, 2026

Enrollment Period

10 months

First QC Date

January 7, 2026

Last Update Submit

April 30, 2026

Conditions

Keywords

sarcopeniaelderlyfrailtyfall preventionmalnutritionhealth-related quality of lifedigital intervention

Outcome Measures

Primary Outcomes (3)

  • Appendicular skeletal muscle mass index (ASMI)

    Appendicular skeletal muscle mass index (ASMI) measured by Bioelectrical impedance analysis (BIA)

    Baseline (T0), 3 months (T1), and 6 months (T2)

  • Handgrip Strength

    Handgrip strength will be measured by a hydraulic hand dynamometer from dominant hand, taking the highest value among 3 measurements. Low muscle strength is defined if male \<28kg, and femal \<18kg.

    Baseline (T0), 3 months (T1), and 6 months (T2)

  • Short Physical Performance Battery (SPPB)

    Physical function will be measured by the Short Physical Performance Battery (SPPB), which combines balance test, gait velocity and chair stand. SPPB score ranges from 0-12, higher score better physical performance. Low physical function is defined by SPPB score ≤9.

    baseline (T0), 3 months (T1), and 3 months (T2)

Secondary Outcomes (9)

  • Sarcopenia and calf circumference scale (SARC-CalF)

    Baseline (T0), 3 months (T1), and 6 months (T2)

  • 11-item Edmonton Frail Scale

    Baseline (T0), 3 months (T1), and 6 months (T2)

  • Timed Up and Go (TUG) test

    Baseline (T0), 3 months (T1), and 6 months (T2)

  • The Mini Nutritional Assessment (MNA)

    Baseline (T0), 3 months (T1), and 6 months (T2)

  • International Physical Activity Questionnaire (IPAQ-Short)

    Baseline (T0), 3 months (T1), and 6 months (T2)

  • +4 more secondary outcomes

Study Arms (2)

Volunteer-Engaged Lifestyle Optimisation via ICOPE for Sarcopenia program (VELO-S)

EXPERIMENTAL

This digital program incorporates a 12-week, volunteer-engaged lifestyle optimisation programme grounded in WHO ICOPE and delivered through an ICOPE-based critical pathway for nutrition and exercise.

Behavioral: Volunteer-Engaged Lifestyle Optimisation via ICOPE for Sarcopenia program (VELO-S)

Attention control

ACTIVE COMPARATOR

To control for the non-specific effects of receiving attention and social interaction on outcomes, participants in the attention control group will receive a comparable duration and frequency of contact and engagement to those in the intervention group. The attention-control group will receive six sessions delivered in a small-group format. The six sessions will be delivered topics that unrelated to sarcopenia, including social health, mental health, cognitive health, insomnia and medication safety. Educational materials will be distributed to participants. Participants will be invited to attend the sessions either by a face-to-face meeting or by telephone call (around 60 minutes) with the research team to talk about the aforementioned topics, ensuring comparable exposure to social engagement and attention.

Behavioral: Attention control

Interventions

The attention control group receives six session meeting covering topics unrelated to sarcopenia, it will be delivered in a small-group with comparable duration and frequency of contact and engagement to those in the intervention group

Attention control

A series of interactive lifestyle empowerment workshops will be conducted at community centres to translate the care plan into sustainable behavioural changes. In addition to one session for individualised care planning, five 90-minute, bi-weekly, in-person, volunteer-enhanced interactive workshops led by nurses will be delivered to equip older adults with knowledge and practical skills to manage sarcopenia. Before interactive workshops, a brief orientation and strategic planning session will focus on the health coach's role, introduce participants to them, and pair each participant with a coach. Participants will be assisted by a corresponding health coach throughout the 12-week intervention workshop.

Volunteer-Engaged Lifestyle Optimisation via ICOPE for Sarcopenia program (VELO-S)

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • aged 60 or above
  • Pseudo-Sarcopenia as indicated by a score on SARC-CaIF ≥11, OR sarcopenia according relative BIA-based appendicular skeletal mass/ height (Men: \<7 kg/m2; women: \<5.7 kg/m2), OR handgrip strength on dominant hand (male \<28 kg, female \<18 kg) (Chen et al., 2025)
  • the ability to use a smartphone, electronic tablet, or computer
  • consent to participate

You may not qualify if:

  • having medical conditions contradictory to physical activity including unstable cardiovascular and orthopaedic conditions
  • engaging in other structured health promotion program involving physical activity and nutritional enhancement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Hong Kong

Hong Kong, Hong Kong

Location

Related Publications (25)

  • Yang Y, Pan N, Luo J, Liu Y, Ossowski Z. Exercise and Nutrition for Sarcopenia: A Systematic Review and Meta-Analysis with Subgroup Analysis by Population Characteristics. Nutrients. 2025 Jul 17;17(14):2342. doi: 10.3390/nu17142342.

  • Wu S, Nan J, Chang J, Jiang D, Cao Z, Zhou S, Feng H, Xiao LD. Adherence to exercise intervention for community-dwelling older adults with sarcopenia: a systematic review and meta-analysis. Age Ageing. 2025 Mar 28;54(4):afaf094. doi: 10.1093/ageing/afaf094.

  • Wang Z, Xu X, Gao S, Wu C, Song Q, Shi Z, Su J, Zang J. Effects of Internet-Based Nutrition and Exercise Interventions on the Prevention and Treatment of Sarcopenia in the Elderly. Nutrients. 2022 Jun 14;14(12):2458. doi: 10.3390/nu14122458.

  • Vijayananthan A, Nawawi O. The importance of Good Clinical Practice guidelines and its role in clinical trials. Biomed Imaging Interv J. 2008 Jan;4(1):e5. doi: 10.2349/biij.4.1.e5. Epub 2008 Jan 1.

  • Tighe SA, Ball K, Kensing F, Kayser L, Rawstorn JC, Maddison R. Toward a Digital Platform for the Self-Management of Noncommunicable Disease: Systematic Review of Platform-Like Interventions. J Med Internet Res. 2020 Oct 28;22(10):e16774. doi: 10.2196/16774.

  • Sum G, Lau LK, Jabbar KA, Lun P, George PP, Munro YL, Ding YY. The World Health Organization (WHO) Integrated Care for Older People (ICOPE) Framework: A Narrative Review on Its Adoption Worldwide and Lessons Learnt. Int J Environ Res Public Health. 2022 Dec 22;20(1):154. doi: 10.3390/ijerph20010154.

  • Rodrigues B, Judice PB, Marques A, Carraca EV, Lopes L, Sousa-Sa E, Encantado J, Videira-Silva A, Cliff DP, Mendes R, Santos R; QMov24h working group. 24-hour Movement Questionnaire (QMov24h) for adults: development process and measurement properties. Int J Behav Nutr Phys Act. 2024 Oct 9;21(1):116. doi: 10.1186/s12966-024-01667-7.

  • Petermann-Rocha F, Gray SR, Pell JP, Ho FK, Celis-Morales C. The joint association of sarcopenia and frailty with incidence and mortality health outcomes: A prospective study. Clin Nutr. 2021 Apr;40(4):2427-2434. doi: 10.1016/j.clnu.2020.10.044. Epub 2020 Nov 1.

  • Perna S, Francis MD, Bologna C, Moncaglieri F, Riva A, Morazzoni P, Allegrini P, Isu A, Vigo B, Guerriero F, Rondanelli M. Performance of Edmonton Frail Scale on frailty assessment: its association with multi-dimensional geriatric conditions assessed with specific screening tools. BMC Geriatr. 2017 Jan 4;17(1):2. doi: 10.1186/s12877-016-0382-3.

  • Pek K, Tan CN, Yew S, Yeo A, Lim JP, Chew J, Lim WS. Letter to the Editor: COVID-19 Pandemic Control Measures: Impact on Social Frailty and Health Outcomes in Non-Frail Community-Dwelling Older Adults. J Nutr Health Aging. 2021;25(6):816-818. doi: 10.1007/s12603-021-1635-1. No abstract available.

  • Park SH, Lee H. Effectiveness of Combined Exercise and Nutrition Interventions in Preventing and Improving Sarcopenia in Frail or Healthy Older Adults: A Systematic Review. Res Gerontol Nurs. 2023 Nov-Dec;16(6):312-320. doi: 10.3928/19404921-20230817-03. Epub 2023 Aug 25.

  • Meza-Valderrama D, Sanchez-Rodriguez D, Pena YC, Ramirez-Fuentes C, Munoz-Redondo E, Morgado-Perez A, Ortiz-Agurto N, Finis-Gallardo P, Marco E. Resistance Training and Nutritional Supplementation in Older Adults with Sarcopenia after Acute Disease: A Feasibility Study. Nutrients. 2024 Sep 10;16(18):3053. doi: 10.3390/nu16183053.

  • Malmstrom TK, Morley JE. SARC-F: a simple questionnaire to rapidly diagnose sarcopenia. J Am Med Dir Assoc. 2013 Aug;14(8):531-2. doi: 10.1016/j.jamda.2013.05.018. Epub 2013 Jun 25. No abstract available.

  • Lee D, Kim M, Won CW. Common and different characteristics among combinations of physical frailty and sarcopenia in community-dwelling older adults: The Korean Frailty and Aging Cohort Study. Geriatr Gerontol Int. 2022 Jan;22(1):42-49. doi: 10.1111/ggi.14314. Epub 2021 Nov 23.

  • Holtrop JS, Estabrooks PA, Gaglio B, Harden SM, Kessler RS, King DK, Kwan BM, Ory MG, Rabin BA, Shelton RC, Glasgow RE. Understanding and applying the RE-AIM framework: Clarifications and resources. J Clin Transl Sci. 2021 May 14;5(1):e126. doi: 10.1017/cts.2021.789. eCollection 2021.

  • Hegde S, Sreeram S, Bhat KR, Satish V, Shekar S, Babu M. Evaluation of post-COVID health status using the EuroQol-5D-5L scale. Pathog Glob Health. 2022 Dec;116(8):498-508. doi: 10.1080/20477724.2022.2035623. Epub 2022 Feb 7.

  • Guo J, Huang X, Dou L, Yan M, Shen T, Tang W, Li J. Aging and aging-related diseases: from molecular mechanisms to interventions and treatments. Signal Transduct Target Ther. 2022 Dec 16;7(1):391. doi: 10.1038/s41392-022-01251-0.

  • Guest, G., Bunce, A., & Johnson, L. (2006). How many interviews are enough? An experiment with data saturation and variability. Field methods, 18(1), 59-82.

    RESULT
  • De Santis KK, Mergenthal L, Christianson L, Busskamp A, Vonstein C, Zeeb H. Digital Technologies for Health Promotion and Disease Prevention in Older People: Scoping Review. J Med Internet Res. 2023 Mar 23;25:e43542. doi: 10.2196/43542.

  • de Fatima Ribeiro Silva C, Ohara DG, Matos AP, Pinto ACPN, Pegorari MS. Short Physical Performance Battery as a Measure of Physical Performance and Mortality Predictor in Older Adults: A Comprehensive Literature Review. Int J Environ Res Public Health. 2021 Oct 10;18(20):10612. doi: 10.3390/ijerph182010612.

  • Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.

  • Lee PH, Macfarlane DJ, Lam TH, Stewart SM. Validity of the International Physical Activity Questionnaire Short Form (IPAQ-SF): a systematic review. Int J Behav Nutr Phys Act. 2011 Oct 21;8:115. doi: 10.1186/1479-5868-8-115.

  • Chen LK, Woo J, Assantachai P, Auyeung TW, Chou MY, Iijima K, Jang HC, Kang L, Kim M, Kim S, Kojima T, Kuzuya M, Lee JSW, Lee SY, Lee WJ, Lee Y, Liang CK, Lim JY, Lim WS, Peng LN, Sugimoto K, Tanaka T, Won CW, Yamada M, Zhang T, Akishita M, Arai H. Asian Working Group for Sarcopenia: 2019 Consensus Update on Sarcopenia Diagnosis and Treatment. J Am Med Dir Assoc. 2020 Mar;21(3):300-307.e2. doi: 10.1016/j.jamda.2019.12.012. Epub 2020 Feb 4.

  • Charlton K, Walton K, Brumerskyj K, Halcomb E, Hull A, Comerford T, do Rosario VA. Model of nutritional care in older adults: improving the identification and management of malnutrition using the Mini Nutritional Assessment&#x2013;Short Form (MNA&#xae;-SF) in general practice. Aust J Prim Health. 2022 Feb;28(1):23-32. doi: 10.1071/PY21053.

  • Bahat G, Ozkok S, Kilic C, Karan MA. SARC-F Questionnaire Detects Frailty in Older Adults. J Nutr Health Aging. 2021;25(4):448-453. doi: 10.1007/s12603-020-1543-9.

MeSH Terms

Conditions

SarcopeniaFrailtyMalnutrition

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and SymptomsPathologic ProcessesNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Doris Sau Fung YU, PhD

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Doris Sau Fung YU, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome assessors will be blinded to the intervention assignment results.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: This RCT randomised 200 older adults at risk of, or diagnosed with, sarcopenia to receive the digital pathway intervention or to an attention control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 7, 2026

First Posted

January 16, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

March 30, 2027

Study Completion (Estimated)

September 30, 2027

Last Updated

May 7, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations