Combined Exercise and Nutrition Intervention for Sarcopenia
NCT ID: NCT06654648
Last Updated: 2024-10-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
118 participants
INTERVENTIONAL
2022-03-29
2024-12-31
Brief Summary
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Detailed Description
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Sarcopenia is emerging health problem and increases medical expenditure as the population ages. Sarcopenia is closely related to chronic diseases and geriatric diseases.
In particular, patients with hip fracture showed a high prevalence of muscle loss and muscle weakness.
It has been reported exercise in sarcopenia patients helped the treatment of the diseases.
Also, it is recently demonstrated that combined exercise-nutrition intervention improved muscle function in elderly patients.
However, there is still not established standard protocol for the combined exercise-nutrition intervention.
Therefore, the aim of this trial is to compare the effects of combined exercise nutrition intervention in sarcopenia patients with multicenter, multidisciplinary, randomized controlled trial.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Combined exercise nutrition intervention group
Customized exercise and nutrition intervention(food for nutrition:whey protein isolate powder) by underlying disease and functional state for 12 weeks during intervention period.
\*Whey protein isolate powder is provided to compensate for the insufficient amount of protein calculated through a questionnaire.
Combined exercise nutrition intervention group
Combination Product: Combined exercise and nutrition intervention Combined exercise and nutrition intervention for 12 weeks (an introductory phase 3 weeks, an expanded phase 3 weeks, and a maintenance phase 6 weeks). Exercise intervention (each 60-min session) includes stretching, resistance exercise, and aerobic exercise according to protocol. Nutritional intervention includes investigating dietary habits and calculate insufficient protein intake using Mini Nutritional Aseessment (MNA) and Korean Protein Assessment Tool (KPAT) to provide customized diet and high protein drink.
Conventional medial care group
Conventional medical care service for 12weeks during intervention period.
Conventional medial care group
Conventional medial care Conventional medical care service for 12weeks during intervention period. Usual care includes medical check-up and exercise and dietary counseling. They were given a brochure about exercise and protein rich foods at their first visit.
The control group patients maintain their usual amount of activity and diet during the 6-month evaluation period. usual activity and dietary habits.
Interventions
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Combined exercise nutrition intervention group
Combination Product: Combined exercise and nutrition intervention Combined exercise and nutrition intervention for 12 weeks (an introductory phase 3 weeks, an expanded phase 3 weeks, and a maintenance phase 6 weeks). Exercise intervention (each 60-min session) includes stretching, resistance exercise, and aerobic exercise according to protocol. Nutritional intervention includes investigating dietary habits and calculate insufficient protein intake using Mini Nutritional Aseessment (MNA) and Korean Protein Assessment Tool (KPAT) to provide customized diet and high protein drink.
Conventional medial care group
Conventional medial care Conventional medical care service for 12weeks during intervention period. Usual care includes medical check-up and exercise and dietary counseling. They were given a brochure about exercise and protein rich foods at their first visit.
The control group patients maintain their usual amount of activity and diet during the 6-month evaluation period. usual activity and dietary habits.
Eligibility Criteria
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Inclusion Criteria
* patients who meet the criteria for the Asian Working Group for Sarcopenia (AWGS) 2019
* patients who had metabolic syndrome
Exclusion Criteria
* patients with musculoskeletal or chronic lung disease incapable of exercise
* patients with untreated or uncontrolled cardiovascular disease which may affect muscle mass or performing exercise
* patients less than 5 years after treatment of malignant tumor
* patients with liver cirrhosis, diabetes and other chronic disease
* patients who cannot perform combined exercise nutrition intervention for other reasons
65 Years
90 Years
ALL
No
Sponsors
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National Evidence-Based Healthcare Collaborating Agency
OTHER_GOV
Seoul Bumin Hospital
OTHER
Responsible Party
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YongChan Ha
The President of Seoul Bumin Hospital
Principal Investigators
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Yongchan Ha, phD
Role: PRINCIPAL_INVESTIGATOR
Bumin Hospital(Seoul)
Locations
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Seoul Bumin Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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References
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Dent E, Morley JE, Cruz-Jentoft AJ, Arai H, Kritchevsky SB, Guralnik J, Bauer JM, Pahor M, Clark BC, Cesari M, Ruiz J, Sieber CC, Aubertin-Leheudre M, Waters DL, Visvanathan R, Landi F, Villareal DT, Fielding R, Won CW, Theou O, Martin FC, Dong B, Woo J, Flicker L, Ferrucci L, Merchant RA, Cao L, Cederholm T, Ribeiro SML, Rodriguez-Manas L, Anker SD, Lundy J, Gutierrez Robledo LM, Bautmans I, Aprahamian I, Schols JMGA, Izquierdo M, Vellas B. International Clinical Practice Guidelines for Sarcopenia (ICFSR): Screening, Diagnosis and Management. J Nutr Health Aging. 2018;22(10):1148-1161. doi: 10.1007/s12603-018-1139-9.
Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jan 1;48(1):16-31. doi: 10.1093/ageing/afy169.
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.
Jang HC. How to Diagnose Sarcopenia in Korean Older Adults? Ann Geriatr Med Res. 2018 Jun;22(2):73-79. doi: 10.4235/agmr.2018.22.2.73. Epub 2018 Jun 30.
Malafarina V, Uriz-Otano F, Malafarina C, Martinez JA, Zulet MA. Effectiveness of nutritional supplementation on sarcopenia and recovery in hip fracture patients. A multi-centre randomized trial. Maturitas. 2017 Jul;101:42-50. doi: 10.1016/j.maturitas.2017.04.010. Epub 2017 Apr 22.
Nipp RD, Fuchs G, El-Jawahri A, Mario J, Troschel FM, Greer JA, Gallagher ER, Jackson VA, Kambadakone A, Hong TS, Temel JS, Fintelmann FJ. Sarcopenia Is Associated with Quality of Life and Depression in Patients with Advanced Cancer. Oncologist. 2018 Jan;23(1):97-104. doi: 10.1634/theoncologist.2017-0255. Epub 2017 Sep 21.
Other Identifiers
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BMH 2022-03-020
Identifier Type: -
Identifier Source: org_study_id
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