ClinicalTrials.gg
RecruitingNCT07345832Updated Sep 8, 2026

The Effect of Volunteer-Engaged Lifestyle Optimisation Via ICOPE on Sarcopenia in Older Adults (VELO-S)

An interventional study of Volunteer-Engaged Lifestyle Optimisation via ICOPE for Sarcopenia program (VELO-S) and Attention control in Sarcopenia, Sarcopenia in Elderly and Fall Prevention in Healthy Aging, sponsored by The University of Hong Kong. Recruiting at 1 site in Hong Kong. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2026-09-08.

Sponsored by The University of Hong Kong · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Started Feb 2026; still recruiting 9 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
60 Years and older
Sex
All
01

Study 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.

Read the detailed description

Sarcopenia-an age-related, progressive syndrome characterised by reduced skeletal muscle strength and mass/quality with impaired physical performance-has become a key modifiable determinant of frailty, falls, disability, hospitalisation, and mortality among community-dwelling older adults. In Hong Kong, approximately 9% of adults aged 65 and above are diagnosed with sarcopenia, indicating a substantial community burden. Beyond functional loss, sarcopenia is associated with increased healthcare utilisation and costs, evidence suggests higher risks of hospital admission and longer length of stay among older adults with sarcopenia, contributing to considerable economic impact.

A key gap in sarcopenia management: many interventions and service models have limited capacity to sustain lifestyle behavioural changes over time.

To address the above gaps, the VELO-S project proposes a 12-week, volunteer-engaged lifestyle optimisation programme grounded in WHO ICOPE and delivered through an ICOPE-based critical pathway for nutrition and exercise. VELO-S is enabled by a digital platform that contains an exhaustive checklist of person-centred risk factors and corresponding, precise lifestyle activity recommendations for each care pathway (nutrition and physical activity). In parallel, VELO-S incorporates goal-oriented empowerment and volunteer-enhanced interactive lifestyle empowerment workshops, targeting the sustainability mechanisms required to deter sarcopenia progression in community-dwelling older adults.

This overall study aims to evaluate the effects and implementation of VELO-S among community-dwelling older adults with pseudo-sarcopenia or sarcopenia.

The objectives of this study are to (1) examine the effectiveness of a 12-week VELO-S intervention compared to an attention control in improving appendicular skeletal muscle mass, handgrip strength, physical mobility function, risk of sarcopenia, frailty, nutrition, physical activity, and health-related quality of life among community-dwelling older adults with sarcopenia risk or sarcopenia at 12 weeks post-intervention and 24 weeks follow-up; (2) to examine changes in health-related quality of life and mental health among volunteers who participated in the health coach capacity training at 12 weeks post-intervention delivery and 24 weeks follow-up, compared to baseline; (3) to explore the engagement experiences and perceived effects of elderly participants with sarcopenia during the program; (4) to explore the perspectives of social care workers on their experience on intervention effects and implementation process.

02

Conditions studied

  • Sarcopenia
  • Sarcopenia in Elderly
  • Fall Prevention in Healthy Aging
  • Frailty Syndrome
  • Malnutrition Elderly
  • Frailty

Keywords

  • sarcopenia
  • elderly
  • frailty
  • fall prevention
  • malnutrition
  • health-related quality of life
  • digital intervention
03

In context

Sarcopenia

1,329 studies on the registry are indexed under Sarcopenia; 420 are open to participants now.

This study's planned enrollment of 200 is above the median of 60 across 855 interventional studies indexed under Sarcopenia.

Browse Sarcopenia studies →

Lead sponsor

The University of Hong Kong is the lead sponsor of 1,292 studies on the registry; 348 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. aged 60 or above
  2. 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)
  3. the ability to use a smartphone, electronic tablet, or computer
  4. consent to participate

Exclusion criteria

Exclusion Criteria:

  1. having medical conditions contradictory to physical activity including unstable cardiovascular and orthopaedic conditions
  2. engaging in other structured health promotion program involving physical activity and nutritional enhancement
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
200 participants (estimated)

Study arms

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

    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)

  • Active comparator
    Attention control

    To control for the non-specific effects of receiving attention and social interaction on outcomes, participants in the attention control group will receive an education protocol that is unrelated to sarcoepnia, with comparable duration and frequency of contact and engagement to those in the intervention group ensuring comparable exposure to social engagement and attention. Educational materials will be distributed to participants.

    Behavioral: Attention control

Interventions

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

    A series of interactive lifestyle empowerment workshops will be conducted at community centres to translate the care plan into sustainable behavioural changes. One brief orientation and strategic planning and individualised care planning session, five volunteer-enhanced interactive workshops led by nurses will be delivered to equip older adults with knowledge and practical skills to manage sarcopenia. Participants will be assisted by a corresponding health coach throughout the 12-week intervention workshop.

  • BehavioralAttention control

    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

06

What researchers measure

Primary outcomes

  1. Appendicular skeletal muscle mass index (ASMI)

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

    Time frame: Baseline (T0), 3 months (T1), and 6 months (T2)

  2. 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.

    Time frame: Baseline (T0), 3 months (T1), and 6 months (T2)

  3. 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.

    Time frame: baseline (T0), 3 months (T1), and 3 months (T2)

Secondary outcomes

  1. Sarcopenia and calf circumference scale (SARC-CalF)

    Sarcopenia and calf circumference scale (SARC-CalF) includes 5 items (strength, assistance with walking, rising from a chair, climbing stairs, Falls, calf circumference). The score ranges from 0 to 20 points, with a score ≥ 11 points suggestive of sarcopenia.

    Time frame: Baseline (T0), 3 months (T1), and 6 months (T2)

  2. 11-item Edmonton Frail Scale

    The Edmonton Frail Scale (EFS) is scored from 0 to 17, with higher scores indicating greater frailty. An EFS score ≥ 8 is generally used as the cutoff for frailty. Scores 6-7 flag patients who are at risk.

    Time frame: Baseline (T0), 3 months (T1), and 6 months (T2)

  3. Timed Up and Go (TUG) test

    Measured by the Timed Up and Go Test in unit of second. A shorter completion time indicates better mobility and balance.

    Time frame: Baseline (T0), 3 months (T1), and 6 months (T2)

  4. The Mini Nutritional Assessment (MNA)

    Measured by the Mini Nutritional Assessment (scores range from 0 to 30), with a lower score indicating a higher risk of malnutrition.

    Time frame: Baseline (T0), 3 months (T1), and 6 months (T2)

  5. International Physical Activity Questionnaire (IPAQ-Short)

    Measured by International Physical Activity Questionnaire is a self-report measure of physical activity. Frenquency and time spent on walking, moderate and vigorous physical activity will be reported. More time spent on physical actiivty indicating a higher physical activity level.

    Time frame: Baseline (T0), 3 months (T1), and 6 months (T2)

  6. The EuroQoL-5D-5L instruments

    Assess the health-related quality of life to generate the utility score for cost-effective analysis. Including the status on mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a 5-level response set, with "unable to" levels mean a worse situation.

    Time frame: Baseline (T0), 3 months (T1), and 6 months (T2)

  7. The EuroQoL-5D-5L Visual Analog Scale

    Assess the health-related quality of lifeby a 0-100 scores Visual Analog Scale to measure perceived health, higher scores mean a better outcome.

    Time frame: Baseline (T0), 3 months (T1), and 6 months (T2)

  8. Lipid Biomarkers

    Assess the comprehensive lipid panel including triglyceride, total cholesterol, high-density lipoprotein and low density lipoprotein through capillary blood samples collected via fingertip puncture

    Time frame: Baseline (T0)

  9. Metabolic Biomarkers

    Assess the fasting glucose through capillary blood samples collected via fingertip puncture

    Time frame: Baseline (T0)

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • 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. PubMed 40732966 ↗
  • 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. PubMed 40253683 ↗
  • 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. PubMed 35745187 ↗
  • 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. PubMed 21614316 ↗
  • 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. PubMed 33112239 ↗
  • 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. PubMed 36612480 ↗
  • 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. PubMed 39385225 ↗
  • 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. PubMed 33189425 ↗
  • 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. PubMed 28049443 ↗
  • 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. PubMed 34179939 ↗
  • 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. PubMed 37616483 ↗
  • 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. PubMed 39339653 ↗
  • 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. PubMed 23810110 ↗
  • 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. PubMed 34816568 ↗
  • 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. PubMed 34367671 ↗
  • 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. PubMed 35129097 ↗
  • 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. PubMed 36522308 ↗
  • 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.
  • 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. PubMed 36951896 ↗
  • 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. PubMed 34682359 ↗
  • 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. PubMed 12900694 ↗
  • 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. PubMed 22018588 ↗
  • 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. PubMed 32033882 ↗
  • 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. PubMed 34911616 ↗
  • 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. PubMed 33786561 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Feb 2026 (actual). Primary completion is estimated for Mar 2027, 13 months after the start.

Of 492 non-industry interventional studies with no phase under Sarcopenia, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 34. This study's planned 13 months is below that.

Counting every sponsor, half of 503 studies reached it within 18 months; a quarter within 8 and three quarters within 34.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 7, 2026
First posted
Jan 16, 2026
StartActual
Feb 1, 2026
Primary completionEst.
Mar 30, 2027
CompletionEst.
Sep 30, 2027
Last update
Sep 8, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07345832
Responsible party
Prof. Yu, Doris Sau Fung (Professor, The University of Hong Kong) — Principal investigator
First posted
Jan 16, 2026
Start date
Feb 1, 2026
Primary completion
Mar 30, 2027 (estimated)
Completion
Sep 30, 2027 (estimated)
Last update
Sep 8, 2026

Study contacts

Doris Sau Fung YU, PhD
Contact
dyu1@hku.hk
852-3917-6319
Doris Sau Fung YU, PhD
principal investigator · The University of Hong Kong

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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