Viewing Study NCT07205133


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Study NCT ID: NCT07205133
Status: NOT_YET_RECRUITING
Last Update Posted: 2025-10-03
First Post: 2025-09-25
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: A Randomized Controlled Trial Comparing Whole Body Vibration Therapy With Usual Care and Usual Care to Improve Muscle Health in Older Adults
Sponsor:
Organization:

Raw JSON

{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000073496', 'term': 'Frailty'}, {'id': 'D055948', 'term': 'Sarcopenia'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized Controlled Trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2027-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-01', 'studyFirstSubmitDate': '2025-09-25', 'studyFirstSubmitQcDate': '2025-10-01', 'lastUpdatePostDateStruct': {'date': '2025-10-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Participant Surveys', 'timeFrame': '2 weeks post intervention up to 3 months post intervention', 'description': 'Survey on user experience and satisfaction as well as feasibility, accessibility'}, {'measure': 'Exercise adherence', 'timeFrame': 'During 4 weeks intervention period', 'description': 'Participants would be instructed to record their exercise participation in an exercise diary with remarks on any symptoms experienced.'}, {'measure': 'Semi-structured interviews', 'timeFrame': '2 weeks post intervention up to 3 months post intervention', 'description': 'Semi-structured interviews would be conducted for the 20 participants in the WBVT (intervention) arm to enhance the qualitative data collected.'}], 'primaryOutcomes': [{'measure': 'Isometric Knee Extension Strength', 'timeFrame': 'Baseline and 2 weeks after intervention and 3 months after intervention', 'description': 'Measured using a JTech Medical, Northstar Echo Muscle Tester with subject seated with knee flexed at 90 degrees and hanging, muscle tester is placed at the ventral surface of the ankle between malleoli and subject instructed to push against tester with maximal effort to extend the knee. Best of three trials would be taken.'}], 'secondaryOutcomes': [{'measure': 'Hand Grip Strength', 'timeFrame': 'Baseline and at 2 weeks post intervention and 3 months post intervention', 'description': 'Measured using Jtech Medical, Northstar Echo Grip hand dynamometer with participant sitting upright with elbows flexed at 90 degrees and arms unsupported, best of 3 tries from each hand.'}, {'measure': 'Appendicular Skeletal Mass Index', 'timeFrame': 'Baseline and at 2 weeks post intervention and 3 months post intervention', 'description': 'Height adjusted Appendicular Skeletal Mass index as measured by the InBody S10 Body Composition Analysis machine'}, {'measure': 'Gait Speed', 'timeFrame': 'Baseline and at 2 weeks post intervention and 3 months post intervention', 'description': '6 metres normal gait speed (metres/second)'}, {'measure': '5-timed chair stands', 'timeFrame': 'Baseline and at 2 weeks post intervention and 3 months post intervention', 'description': 'Time taken to perform 5 chair stands with both arms crossed over chest (seconds)'}, {'measure': 'Calf Circumference', 'timeFrame': 'Baseline and at 2 weeks post intervention and 3 months post intervention', 'description': 'Widest calf circumference with participant in standing position'}, {'measure': 'Physical Activity Scale for the Elderly (PASE)', 'timeFrame': 'Baseline and at 2 weeks post intervention and 3 months post intervention', 'description': 'Assessment for physical activity level according to the PASE questionnaire'}, {'measure': 'Quality of life scale', 'timeFrame': 'Baseline and at 2 weeks post intervention and 3 months post intervention', 'description': 'QOL measured with the EQ-5D-5L'}, {'measure': 'Number of falls', 'timeFrame': '1 year post interventions', 'description': 'Number of falls per participant during study period'}, {'measure': '1 year unplanned emergency department visits and hospitalisation events', 'timeFrame': '1 year post interventions', 'description': 'as described above'}, {'measure': 'All-cause mortality', 'timeFrame': 'up to 1 year post interventions', 'description': 'Mortality all-cause'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Aging', 'Frailty', 'Sarcopenia', 'Whole Body Vibration Therapy', 'Muscle Strength', 'Muscle Function', 'Muscle Mass'], 'conditions': ['Aging', 'Frailty', 'Sarcopenia', 'Muscle Strength', 'Muscle Function', 'Muscle Mass']}, 'referencesModule': {'references': [{'pmid': '27590604', 'type': 'BACKGROUND', 'citation': 'Dyer SM, Crotty M, Fairhall N, Magaziner J, Beaupre LA, Cameron ID, Sherrington C; Fragility Fracture Network (FFN) Rehabilitation Research Special Interest Group. 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Br J Sports Med. 2023 Sep;57(18):1211-1220. doi: 10.1136/bjsports-2023-106807. Epub 2023 Jul 6."}, {'pmid': '35150587', 'type': 'BACKGROUND', 'citation': 'Hurst C, Robinson SM, Witham MD, Dodds RM, Granic A, Buckland C, De Biase S, Finnegan S, Rochester L, Skelton DA, Sayer AA. Resistance exercise as a treatment for sarcopenia: prescription and delivery. Age Ageing. 2022 Feb 2;51(2):afac003. doi: 10.1093/ageing/afac003.'}, {'pmid': '32963629', 'type': 'BACKGROUND', 'citation': 'Wu S, Ning HT, Xiao SM, Hu MY, Wu XY, Deng HW, Feng H. Effects of vibration therapy on muscle mass, muscle strength and physical function in older adults with sarcopenia: a systematic review and meta-analysis. Eur Rev Aging Phys Act. 2020 Sep 17;17:14. doi: 10.1186/s11556-020-00247-5. eCollection 2020.'}, {'pmid': '37390692', 'type': 'BACKGROUND', 'citation': 'Yi M, Zhang W, Zhang X, Zhou J, Wang Z. The effectiveness of Otago exercise program in older adults with frailty or pre-frailty: A systematic review and meta-analysis. Arch Gerontol Geriatr. 2023 Nov;114:105083. doi: 10.1016/j.archger.2023.105083. Epub 2023 Jun 22.'}, {'pmid': '22609157', 'type': 'BACKGROUND', 'citation': 'Lam FM, Lau RW, Chung RC, Pang MY. The effect of whole body vibration on balance, mobility and falls in older adults: a systematic review and meta-analysis. Maturitas. 2012 Jul;72(3):206-13. doi: 10.1016/j.maturitas.2012.04.009. Epub 2012 May 18.'}, {'pmid': '37999785', 'type': 'BACKGROUND', 'citation': 'Remer F, Keilani M, Kull P, Crevenna R. Effects of whole-body vibration therapy on pain, functionality, postural stability, and proprioception in patients with subacute and chronic non-specific low back pain: a systematic review. Wien Med Wochenschr. 2025 Feb;175(1-2):20-40. doi: 10.1007/s10354-023-01026-4. Epub 2023 Nov 24.'}, {'pmid': '25904085', 'type': 'BACKGROUND', 'citation': 'Gloeckl R, Heinzelmann I, Kenn K. Whole body vibration training in patients with COPD: A systematic review. Chron Respir Dis. 2015 Aug;12(3):212-21. doi: 10.1177/1479972315583049. Epub 2015 Apr 22.'}, {'pmid': '35329010', 'type': 'BACKGROUND', 'citation': 'Nowak-Lis A, Nowak Z, Gabrys T, Szmatlan-Gabrys U, Batalik L, Knappova V. The Use of Vibration Training in Men after Myocardial Infarction. Int J Environ Res Public Health. 2022 Mar 11;19(6):3326. doi: 10.3390/ijerph19063326.'}, {'pmid': '35174868', 'type': 'BACKGROUND', 'citation': 'Qiu CG, Chui CS, Chow SKH, Cheung WH, Wong RMY. Effects of Whole-Body Vibration Therapy on Knee Osteoarthritis: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. J Rehabil Med. 2022 Mar 29;54:jrm00266. doi: 10.2340/jrm.v54.2032.'}, {'pmid': '36367314', 'type': 'BACKGROUND', 'citation': 'Yang X, Xue X, Tu H, Li N. Effect of whole-body vibration training on the recovery of lower limb function in people with stroke: a systematic review and meta-analysis. Disabil Rehabil. 2023 Nov;45(23):3823-3832. doi: 10.1080/09638288.2022.2138993. Epub 2022 Nov 11.'}, {'pmid': '28657911', 'type': 'BACKGROUND', 'citation': 'Costantino C, Bertuletti S, Romiti D. Efficacy of Whole-Body Vibration Board Training on Strength in Athletes After Anterior Cruciate Ligament Reconstruction: A Randomized Controlled Study. Clin J Sport Med. 2018 Jul;28(4):339-349. doi: 10.1097/JSM.0000000000000466.'}, {'pmid': '29471456', 'type': 'BACKGROUND', 'citation': 'Lai CC, Tu YK, Wang TG, Huang YT, Chien KL. Effects of resistance training, endurance training and whole-body vibration on lean body mass, muscle strength and physical performance in older people: a systematic review and network meta-analysis. 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Nutritional, Physical, Cognitive, and Combination Interventions and Frailty Reversal Among Older Adults: A Randomized Controlled Trial. Am J Med. 2015 Nov;128(11):1225-1236.e1. doi: 10.1016/j.amjmed.2015.06.017. Epub 2015 Jul 6.'}, {'pmid': '36346721', 'type': 'BACKGROUND', 'citation': 'Lim WS, Cheong CY, Lim JP, Tan MMY, Chia JQ, Malik NA, Tay L. Singapore Clinical Practice Guidelines For Sarcopenia: Screening, Diagnosis, Management and Prevention. J Frailty Aging. 2022;11(4):348-369. doi: 10.14283/jfa.2022.59.'}, {'pmid': '32033882', 'type': 'BACKGROUND', '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': '28648901', 'type': 'BACKGROUND', 'citation': 'Dent E, Lien C, Lim WS, Wong WC, Wong CH, Ng TP, Woo J, Dong B, de la Vega S, Hua Poi PJ, Kamaruzzaman SBB, Won C, Chen LK, Rockwood K, Arai H, Rodriguez-Manas L, Cao L, Cesari M, Chan P, Leung E, Landi F, Fried LP, Morley JE, Vellas B, Flicker L. The Asia-Pacific Clinical Practice Guidelines for the Management of Frailty. J Am Med Dir Assoc. 2017 Jul 1;18(7):564-575. doi: 10.1016/j.jamda.2017.04.018.'}, {'pmid': '31609229', 'type': 'BACKGROUND', 'citation': 'Dent E, Martin FC, Bergman H, Woo J, Romero-Ortuno R, Walston JD. Management of frailty: opportunities, challenges, and future directions. Lancet. 2019 Oct 12;394(10206):1376-1386. doi: 10.1016/S0140-6736(19)31785-4.'}, {'pmid': '24257468', 'type': 'BACKGROUND', 'citation': 'Dent E, Chapman I, Howell S, Piantadosi C, Visvanathan R. Frailty and functional decline indices predict poor outcomes in hospitalised older people. Age Ageing. 2014 Jul;43(4):477-84. doi: 10.1093/ageing/aft181. Epub 2013 Nov 19.'}, {'pmid': '31609228', 'type': 'BACKGROUND', 'citation': 'Hoogendijk EO, Afilalo J, Ensrud KE, Kowal P, Onder G, Fried LP. Frailty: implications for clinical practice and public health. Lancet. 2019 Oct 12;394(10206):1365-1375. doi: 10.1016/S0140-6736(19)31786-6.'}], 'seeAlsoLinks': [{'url': 'https://www.moh.gov.sg/resources-statistics/reports/frailty-strategy-policy-report', 'label': 'Ministry of Health Singapore. MOH Frailty Strategy Policy Report \\[Internet\\]. \\[cited 2024 Sep 5\\]'}, {'url': 'https://www.moh.gov.sg/resources-statistics/reports/national-population-health-survey-2022', 'label': 'Ministry of Health Singapore. National Population Healthy Survey 2022 \\[Internet\\]. \\[cited 2024 Sep 5\\]'}, {'url': 'https://www.healthiersg.gov.sg/resources/white-paper/', 'label': 'Ministry of Health Singapore. The White Paper on Healthier SG \\[Internet\\]. \\[cited 2024 Sep 5\\]'}]}, 'descriptionModule': {'briefSummary': 'This study is a randomized controlled trial where participants would be randomly assigned to one of 2 groups. One group would receive Whole body vibration therapy and usual care and the other group only usual care. Measurements of muscle mass, strength and function would be taken before the interventions, and at 2 other points after interventions. Differences in the outcomes between the two groups would be analysed.', 'detailedDescription': 'Background: The prevalence of Frailty and Sarcopenia is increasing with increasing proportion of older adults in the population. While screening for frailty and sarcopenia has become more common, frailty interventions are still developing. Effective interventions include resistance exercise programs that are progressive and sustained. However, take up rate and adherence to these programs are low due to many barriers like time, cost and convenience to the older adult. Many older adults who are frail may be unable to adhere to exercise programs due to cognitive impairment and tolerability. An alternative modality, Whole Body Vibration Training (WBVT), has emerged with evidence in improving muscle strength and function which may be easier to complete and a safe alternative.\n\nAim: Our study aims to evaluate the effectiveness of a novel progressive 4-week, thrice-weekly WBVT intervention and usual care compared to usual care in improving muscle mass, strength and function in the pre-frail and mildly frail older adult.\n\nMethods: 20 participants would be randomly allocated to each arm. The primary outcome is the between-group difference in change in maximal isometric knee-extension strength from baseline to 2 weeks post-intervention. Secondary outcomes include Appendicular Skeletal Mass Index (ASMI), hand grip strength (HGS), gait speed (GS), 5 timed chair stands, Quality of life (EQ-5D-5L) and physical activity level using the Physical Activity Scale for the Elderly (PASE). Other secondary outcomes include falls rate during the study, 1-year unplanned emergency department visits, hospitalizations as well as all-cause mortality. The measurements would be done at 3 points, namely pre-intervention (baseline), 2 weeks post-intervention and at 3 months. Qualitative data would include participant surveys and semi-structured interviews to assess feasibility, accessibility and future implementation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy Volunteer or Patients aged 65 and above,\n* Clinical frailty Scale (CFS) score of 3-4,\n* Independently ambulating without any aid\n* willingness and consent to participate in the study and ability to travel to the study-site for the measurements and interventions, and\n* participants with no regular exercise habits (defined as less than 150mins/week of moderate intensity aerobic exercise and less than twice a week of strengthening exercises)for past 3 months.\n\nExclusion Criteria:\n\n* current active enrolment into any Day Rehab or community exercise program,\n* contraindications to WBVT machine usage (see below),\n* diagnosis of dementia,\n* history of Diabetes Mellitus\n* BMI ≤20kg/m2,\n* recent hospital admissions within the last 3 months,\n* end stage organ failure,\n* chronic diseases which are not well managed, for example, poorly controlled hypertension,\n* New York Heart Association (NYHA) score II and above for patients with history of heart failure and\n* MUST Score ≥1.\n\nContraindications to WBVT:\n\nPRIMARY CONTRAINDICATIONS TO WBVT\n\n* Pregnancy\n* Acute thrombosis (acute vascular occlusion)\n* Artificial joints in stimulated body regions\n* Fresh fractures in stimulated body regions\n* Within 3 months post surgery/procedure and/or any fresh wounds and scars in the stimulated body regions\n* or if the wound healing is not yet completely finished.\n\nSECONDARY CONTRAINDICATIONS TO WBVT\n\n* Acute inflammation of the musculoskeletal system, activated arthrosis or\n* arthropathy (e.g. acute inflammation and swelling in joints).\n* Acute tendinopathies in stimulated body regions (acute tendonitis)\n* Acute hernias (tissue ruptures)\n* Acute discopathy (acute disc-related back problem)\n* Stone disease of the bile ducts and urinary tract\n* Rheumatoid Arthritis\n* Epilepsy due to secondary risk of injury'}, 'identificationModule': {'nctId': 'NCT07205133', 'briefTitle': 'A Randomized Controlled Trial Comparing Whole Body Vibration Therapy With Usual Care and Usual Care to Improve Muscle Health in Older Adults', 'organization': {'class': 'OTHER', 'fullName': 'Changi General Hospital'}, 'officialTitle': 'Effectiveness of Whole Body Vibration Therapy and Usual Care Compared to Usual Care in Improving Muscle Mass, Strength and Function in Older Adults', 'orgStudyIdInfo': {'id': 'ECOS Ref: 2025-0362'}, 'secondaryIdInfos': [{'id': 'AM/AG001/2025 (SRDUKAMR25G1)', 'type': 'OTHER_GRANT', 'domain': 'Singhealth Duke-NUS Academic Medicine Research Grant 2.0 FY 2025: Special Category (Ageing Research- AGER)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Whole Body Vibration Training', 'description': 'The WBVT would be conducted using the Galileo Vibration machine (Galileo® S 35), for 3 sessions per week for 4 weeks.\n\nThe participants would be progressed in terms of (i)vibration frequency from 15 Hz to at least 25 Hz (maximum 30 Hz for those who can tolerate) (ii)for the angles of their squats (from an approximate starting point of 20 degrees ("mini squats" to 45 degrees "quarter squats"; maximum to 90 degrees-thighs parallel to ground or "half-squats" for those who can tolerate); as well as (iii) increasing number of each 1-minute set (from 6 to 8 sets), while standing on the WBVT machine barefoot with both feet flat on the platform set at an amplitude of 2-3mm (according to the participant\'s height and body physique) with variable rest breaks (up to 1 minute) between each set for a total of 15 minutes each training session.\n\nAny missed session would be recorded. To ensure compliance, the subjects would receive a standard phone-call/text reminder prior to the scheduled session.', 'interventionNames': ['Other: Whole Body Vibration Training', 'Other: Otago Exercise']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Usual Care', 'description': 'Participants from both arms would also be provided the exercise sheet on "Otago exercises" (30)and demonstrated in one session how to perform the exercises. In-person demonstration of the "Otago exercises" would be done upon recruitment by trained study team members, at the visit for baseline measurements and a return-demonstration would be done after. They would be instructed to perform the Otago exercises daily according to the standardized instructions stated and progressed from 10 to 15 repetitions on their own for at least 3 times a week and advised to also continue other aerobic exercises, for example, brisk walking. Participants would be given an exercise and falls diary to record their exercise participation as well as any falls that occurred during the study duration for up to 3 months.', 'interventionNames': ['Other: Otago Exercise']}], 'interventions': [{'name': 'Whole Body Vibration Training', 'type': 'OTHER', 'description': 'Information already included in arm/group descriptions.', 'armGroupLabels': ['Whole Body Vibration Training']}, {'name': 'Otago Exercise', 'type': 'OTHER', 'description': 'Usual Care', 'armGroupLabels': ['Usual Care', 'Whole Body Vibration Training']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Christine Yuanxin Chen, MBBS', 'role': 'CONTACT', 'email': 'christine.chen.y.x@singhealth.com.sg', 'phone': '+65-9030 4976'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data will not be shared at this time because participants were not explicitly consented for data sharing.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Changi General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'BMEC Pte Ltd', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Christine Chen Yuanxin', 'investigatorAffiliation': 'Changi General Hospital'}}}}