Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 12:15 AM
Study NCT ID:
NCT07345832
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-21
First Post:
2026-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Digital Pathway to Healthy Aging: Sarcopenia-Frailty Integrated Training
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055948', 'term': 'Sarcopenia'}, {'id': 'D000073496', 'term': 'Frailty'}, {'id': 'D044342', 'term': 'Malnutrition'}], 'ancestors': [{'id': 'D009133', 'term': 'Muscular Atrophy'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001284', 'term': 'Atrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Outcome assessors will be blinded to the intervention assignment results.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This Randomized Controlled Trial randomized 200 older adults with risk of, or diagnosed with, sarcopenia and frailty to receive the digital pathway intervention or a waiting list control group'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02-28', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-18', 'studyFirstSubmitDate': '2026-01-07', 'studyFirstSubmitQcDate': '2026-01-07', 'lastUpdatePostDateStruct': {'date': '2026-01-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Appendicular skeletal muscle mass index (ASMI)', 'timeFrame': 'Baseline (T0), 3 months (T1), and 6 months (T2)', 'description': 'Appendicular skeletal muscle mass index (ASMI) measured by Bioelectrical impedance analysis (BIA)'}, {'measure': 'Handgrip Strength', 'timeFrame': 'Baseline (T0), 3 months (T1), and 6 months (T2)', 'description': '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.'}, {'measure': 'Short Physical Performance Battery (SPPB)', 'timeFrame': 'baseline (T0), 3 months (T1), and 3 months (T2)', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Sarcopenia and calf circumference scale (SARC-CalF)', 'timeFrame': 'Baseline (T0), 3 months (T1), and 6 months (T2)', 'description': '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.'}, {'measure': '11-item Edmonton Frail Scale', 'timeFrame': 'Baseline (T0), 3 months (T1), and 6 months (T2)', 'description': '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.'}, {'measure': 'Timed Up and Go (TUG) test', 'timeFrame': 'Baseline (T0), 3 months (T1), and 6 months (T2)', 'description': 'Measured by the Timed Up and Go Test in unit of second. A shorter completion time indicates better mobility and balance.'}, {'measure': 'The Mini Nutritional Assessment (MNA)', 'timeFrame': 'Baseline (T0), 3 months (T1), and 6 months (T2)', 'description': 'Measured by the Mini Nutritional Assessment (scores range from 0 to 30), with a lower score indicating a higher risk of malnutrition.'}, {'measure': 'International Physical Activity Questionnaire (IPAQ-Short)', 'timeFrame': 'Baseline (T0), 3 months (T1), and 6 months (T2)', 'description': '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.'}, {'measure': 'Sleep duration', 'timeFrame': 'Baseline (T0), 3 months (T1), and 6 months (T2)', 'description': 'Sleep duration in daytime and night on weekday and weekend'}, {'measure': 'The EuroQoL-5D-5L instruments', 'timeFrame': 'Baseline (T0), 3 months (T1), and 6 months (T2)', 'description': 'Assess the health-related quality of life to generate the utility score for cost-effective analysis. It consists of two parts, with the first part to assess the health status on mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a 5-level (no problems, slight problems , moderate problems, severe problems and unable to) response set, with "unable to" levels mean a worse situation. The second part as a 0-100 scores VAS to measure perceived health, higher scores mean a better outcome.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sarcopenia', 'elderly', 'frailty', 'fall prevention', 'malnutrition', 'health-related quality of life', 'digital intervention'], 'conditions': ['Sarcopenia', 'Sarcopenia in Elderly', 'Fall Prevention in Healthy Aging', 'Frailty', 'Malnutrition Elderly']}, 'referencesModule': {'references': [{'pmid': '40732966', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '40253683', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '35745187', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '21614316', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '33112239', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '36612480', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '39385225', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '33189425', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '28049443', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '34179939', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '37616483', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '39339653', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '23810110', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '34816568', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '34367671', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '35129097', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '36522308', 'type': 'RESULT', 'citation': '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.'}, {'type': 'RESULT', 'citation': '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.'}, {'pmid': '36951896', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '34682359', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '12900694', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '22018588', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '32033882', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '34911616', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '33786561', 'type': 'RESULT', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'Sarcopenia and frailty prevention and management are highly prioritized goals in the Healthy Aging agenda. The study aims to evaluate the effects and implementation of the digital critical pathway to improve sarcopenia and frailty, reduce fall risk, and increase health-related quality of life among community-dwelling older adults with risk of, or diagnosed with, sarcopenia and frailty', 'detailedDescription': "Population ageing is accelerating globally and regionally, widening the gap between life expectancy and healthy life expectancy, mainly due to late-life declines in physical function and mobility (Guo et al., 2022). Sarcopenia and frailty are major age-associated public health issues that contribute to a decline in functional ability, increased fall risks, and mortality (Lee et al., 2022; Petermann-Rocha et al., 2021). Nutrition and physical activity integrated interventions are recommended as primary treatment for sarcopenia and frailty (Park \\& Lee, 2023). However, current interventions are often generic, resulting in non-precise, non-personalized interventions, usually failing to accommodate individual differences in baseline strength and mobility, nutrition status, comorbidities, preferences, and home environments (Tighe et al., 2020). Consequently, interventions are complex to personalise, adjustments are delayed, and adherence is suboptimal, undermining real-world effectiveness. Future community-based health agendas should prioritize long-term care that removes access barriers (such as mobility and transportation) and transitions from generic care to precision personalization.\n\nThe World Health Organisation's Decade of Healthy Ageing and the Integrated Care for Older People (ICOPE) framework provide a practice anchor to maintain intrinsic capacity through person-centred assessment, individualised goal-setting, and continuous follow-up. Within this paradigm, sarcopenia and frailty management apply ICOPE via protocol-driven critical pathways (Sum et al., 2022)-structured decision support that links risk assessment to tailored prescriptions and follow-up-can standardise quality while enabling precise personalisation across diverse home settings.\n\nDigital health interventions have expanded their capabilities to include remote exercise prescription, microlearning, reminders, and tele-coaching, with evidence of benefits for physical activity, fitness, body composition, and patient-reported outcomes (De Santis et al., 2023). Utilising a user-friendly digital tool to streamline functional assessments and develop personalised health plans is a promising approach.\n\nA digital platform-enabled intervention, grounded in the WHO ICOPE framework and a protocol-driven critical pathway, is proposed to identify care needs among community-dwelling older adults. This tool will allow healthcare providers to accurately assess individual needs and tailor interventions in exercise and nutrition, ensuring a focused, effective approach to combating sarcopenia and frailty in older adults."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* aged 60 or above\n* Pseudo-Sarcopenia/Sarcopenia: SARC-CaIF ≥ 11, AND (Grip Strength on dominant hand (male \\<28 kg, female \\<18 kg), OR Chair Stand Test (5 times) ≥ 12 seconds, OR Short Physical Performance Battery Score ≤ 9; OR relative appendicular skeletal mass/ height (Men: \\<7 kg/m2; women: \\<5.7 kg/m2) ); AND/OR Prefrail/ frail based on the Edmonton Frail Scale Score ≥ 6.\n* consent to participate\n\nExclusion Criteria:\n\n* having conditions contradictory to physical activity\n* engaging in other ongoing physical activity and nutrition programs'}, 'identificationModule': {'nctId': 'NCT07345832', 'briefTitle': 'Digital Pathway to Healthy Aging: Sarcopenia-Frailty Integrated Training', 'organization': {'class': 'OTHER', 'fullName': 'The University of Hong Kong'}, 'officialTitle': 'Digital Pathway to Healthy Aging: Sarcopenia-Frailty Integrated Training', 'orgStudyIdInfo': {'id': 'D-Path-HA: S-FIT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Digital Pathway to Healthy Aging: Sarcopenia-Frailty Integrated Training program', 'description': 'This digital program will address sarcopenia and frailty with a 12-week integrated intervention based on integrated exercise, nutrition, and fall-prevention.', 'interventionNames': ['Behavioral: Digital Pathway to Healthy Aging: Sarcopenia-Frailty Integrated Training program (D-Path-HA: S-FIT)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Waitlist Control', 'description': 'The control group will receive general education on nutrition and physical activity guidelines for older adults, and the same pathway intervention will be applied to the control group after all data collection', 'interventionNames': ['Behavioral: Waitlist Control']}], 'interventions': [{'name': 'Digital Pathway to Healthy Aging: Sarcopenia-Frailty Integrated Training program (D-Path-HA: S-FIT)', 'type': 'BEHAVIORAL', 'description': 'This digital program will address sarcopenia and frailty with a 12-week integrated intervention based on integrated exercise, nutrition, and fall-prevention. The intervention will be delivered by registered nurses, social workers, and health coach captains. Guided by the critical pathway and empowerment cycle framework, including a (1) Personalised Health Prescription Phase, (2) 12-Week Empowerment and Social Activity Phase, including six bi-weekly, in-person sessions empowerment workshop; scenario-based health message broadcast; case meeting.', 'armGroupLabels': ['Digital Pathway to Healthy Aging: Sarcopenia-Frailty Integrated Training program']}, {'name': 'Waitlist Control', 'type': 'BEHAVIORAL', 'description': 'The control group will receive general education on nutrition and physical activity guidelines for older adults, and the same pathway intervention will be applied to the control group after all data collection.', 'armGroupLabels': ['Waitlist Control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'country': 'Hong Kong', 'contacts': [{'name': 'Doris Sau Fung YU, PhD', 'role': 'CONTACT', 'email': 'dyu1@hku.hk', 'phone': '852-3917-6319'}], 'facility': 'The University of Hong Kong', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'centralContacts': [{'name': 'Doris Sau Fung YU, PhD', 'role': 'CONTACT', 'email': 'dyu1@hku.hk', 'phone': '852-3917-6319'}], 'overallOfficials': [{'name': 'Doris Sau Fung YU, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Hong Kong'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Prof. Yu, Doris Sau Fung', 'investigatorAffiliation': 'The University of Hong Kong'}}}}