- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07345832
The Effect of Volunteer-Engaged Lifestyle Optimisation Via ICOPE on Sarcopenia in Older Adults (VELO-S)
The Effect of Volunteer-Engaged Lifestyle Optimisation Via ICOPE on Sarcopenia in Older Adults (VELO-S): A Randomised Controlled Trial
Study Overview
Status
Conditions
Detailed Description
Population ageing is accelerating worldwide, and the widening gap between life expectancy and healthy life expectancy is increasingly driven by late-life declines in physical function and mobility. 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. Using the Asian Working Group for Sarcopenia (AWGS) criteria, a systematic review and meta-analysis of studies in China reported a pooled prevalence of 12.9% 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.
Contemporary consensus definitions (e.g., EWGSOP2 and AWGS) identify low muscle strength as the central feature, with muscle quantity/quality and physical performance used to confirm diagnosis and grade severity, which aligns management with interventions targeting strength, function, and nutritional status. Accordingly, guideline-based care emphasizes two key modalities: optimizing nutrition-particularly adequate protein intake to support muscle protein synthesis and, where indicated, correcting vitamin D deficiency-and implementing exercise programs centered on progressive resistance training, often complemented by functional and balance components to improve mobility and reduce falls risk. Evidence further suggests that combined exercise and nutritional strategies can outperform single-modality approaches for improving outcomes relevant to sarcopenia, including strength and physical performance.
Despite substantial evidence supporting lifestyle interventions, particularly exercise and nutritional optimization-for improving sarcopenia-related outcomes, these benefits are often time-limited in practice. When structured program support ends, the effective intervention "dose" commonly declines (e.g., reduced training frequency/intensity and weaker adherence to dietary targets), and improvements in strength, function, and overall physical performance may attenuate accordingly. This pattern is consistent with real-world evidence indicating that sustained benefits depend heavily on continued participation and adherence, with lower adherence associated with smaller functional gains than those observed under supervised or trial conditions. Therefore, for a progressive and chronic condition such as sarcopenia, the key challenge is not only initiating behavior change but ensuring that exercise and dietary practices are maintained and embedded into daily routines so that benefits can persist.
The above evidence underscores a key gap in sarcopenia management: many interventions and service models have limited capacity to sustain lifestyle behavioural changes over time. Maintenance requires that evidence-based recommendations be translated into routinised daily practices, supported by (i) person-centred assessment and tailoring, (ii) empowerment and goal-oriented self-management, and (iii) ongoing social reinforcement (peer/volunteer support) with timely follow-up. The WHO Integrated Care for Older People (ICOPE) framework provides a pragmatic structure to operationalise these requirements through intrinsic capacity assessment, personalised care planning, and continued community follow-up.
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). After baseline screening, trained social care workers conduct care mapping to identify each participant's key barriers and preferences, select relevant risk factors within the platform, and generate a tailored set of recommended lifestyle actions. A simple personalised report summarising risk factors and agreed actions can then be produced (electronic or hard copy) for participants and the matched health coach, supporting shared understanding, goal-oriented follow-up, and iterative adjustment. In parallel, VELO-S incorporates goal-oriented empowerment and volunteer-enhanced interactive lifestyle empowerment workshops to strengthen motivation, social support, and practical capability for maintaining nutritional and activity changes, thereby 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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Doris Sau Fung YU, PhD
- Phone Number: 852-3917-6319
- Email: dyu1@hku.hk
Study Locations
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Hong Kong, Hong Kong
- The University of Hong Kong
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Contact:
- Doris Sau Fung YU, PhD
- Phone Number: 852-3917-6319
- Email: dyu1@hku.hk
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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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.
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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.
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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 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.
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Appendicular skeletal muscle mass index (ASMI)
Time Frame: Baseline (T0), 3 months (T1), and 6 months (T2)
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Appendicular skeletal muscle mass index (ASMI) measured by Bioelectrical impedance analysis (BIA)
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Baseline (T0), 3 months (T1), and 6 months (T2)
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Handgrip Strength
Time Frame: Baseline (T0), 3 months (T1), and 6 months (T2)
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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.
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Baseline (T0), 3 months (T1), and 6 months (T2)
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Short Physical Performance Battery (SPPB)
Time Frame: baseline (T0), 3 months (T1), and 3 months (T2)
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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.
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baseline (T0), 3 months (T1), and 3 months (T2)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Sarcopenia and calf circumference scale (SARC-CalF)
Time Frame: Baseline (T0), 3 months (T1), and 6 months (T2)
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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.
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Baseline (T0), 3 months (T1), and 6 months (T2)
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Timed Up and Go (TUG) test
Time Frame: Baseline (T0), 3 months (T1), and 6 months (T2)
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Measured by the Timed Up and Go Test in unit of second.
A shorter completion time indicates better mobility and balance.
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Baseline (T0), 3 months (T1), and 6 months (T2)
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The Mini Nutritional Assessment (MNA)
Time Frame: Baseline (T0), 3 months (T1), and 6 months (T2)
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Measured by the Mini Nutritional Assessment (scores range from 0 to 30), with a lower score indicating a higher risk of malnutrition.
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Baseline (T0), 3 months (T1), and 6 months (T2)
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11-item Edmonton Frail Scale
Time Frame: Baseline (T0), 3 months (T1), and 6 months (T2)
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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.
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Baseline (T0), 3 months (T1), and 6 months (T2)
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International Physical Activity Questionnaire (IPAQ-Short)
Time Frame: Baseline (T0), 3 months (T1), and 6 months (T2)
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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.
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Baseline (T0), 3 months (T1), and 6 months (T2)
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The EuroQoL-5D-5L instruments
Time Frame: Baseline (T0), 3 months (T1), and 6 months (T2)
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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.
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Baseline (T0), 3 months (T1), and 6 months (T2)
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The EuroQoL-5D-5L Visual Analog Scale
Time Frame: Baseline (T0), 3 months (T1), and 6 months (T2)
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Assess the health-related quality of lifeby a 0-100 scores Visual Analog Scale to measure perceived health, higher scores mean a better outcome.
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Baseline (T0), 3 months (T1), and 6 months (T2)
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Lipid Biomarkers
Time Frame: Baseline (T0)
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Assess the comprehensive lipid panel including triglyceride, total cholesterol, high-density lipoprotein and low density lipoprotein through capillary blood samples collected via fingertip puncture
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Baseline (T0)
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Metabolic Biomarkers
Time Frame: Baseline (T0)
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Assess the fasting glucose through capillary blood samples collected via fingertip puncture
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Baseline (T0)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Doris Sau Fung YU, PhD, The University of Hong Kong
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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–Short Form (MNA®-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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Nervous System Diseases
- Neuromuscular Manifestations
- Pathologic Processes
- Nutrition Disorders
- Pathological Conditions, Anatomical
- Muscular Atrophy
- Atrophy
- Pathological Conditions, Signs and Symptoms
- Nutritional and Metabolic Diseases
- Signs and Symptoms
- Frailty
- Malnutrition
- Sarcopenia
Other Study ID Numbers
- VELO-S
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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