Combined Exercise and Nutrition Intervention for Sarcopenia

NCT06654648 | Recruiting DMC

• 1 other identifier: BMH 2022-03-020
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to demonstrate the effect of combined exercise-nutrition intervention in old adults with sarcopenia. This study will be conducted with prospectively randomized controlled trial comparing outcome of combined exercise-nutrition intervention with conventional medical care. Handgrip strength, gait speed, knee extensor muscle power, physical performance, muscle mass using DEXA, quality of life, activities of daily living, sarcopenia screening questionnaire, nutritional assessment will be evaluated on baseline, 12-weeks and 24-weeks after intervention

Conditions

Sarcopenia

Keywords

Sarcopenia; Older adults; Exercise; Nutrition; Standard intervention

Outcome Measures

Primary Outcomes (1)

• 5-times chair stand test

  Change from baseline 5-times chair stand test to 12 weeks after assessment, measured by 5-times chair stand test

  [Time Frame: Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3)]

Secondary Outcomes (1)

• Physical performance

  [Time Frame: Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3)]

Other Outcomes (14)

• Gait speed test

  [Time Frame: Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3)]

• Appendicular skeletal muscle mass

  [Time Frame: Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3)]

• Health Related Quality of Life

  [Time Frame: Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3)]

Study Arms (2)

Combined exercise nutrition intervention group

EXPERIMENTAL

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.

Other: Combined exercise nutrition intervention group

Conventional medial care group

ACTIVE COMPARATOR

Conventional medical care service for 12weeks during intervention period.

Other: Conventional medial care group

Interventions

Combined exercise nutrition intervention group OTHER

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.

Combined exercise nutrition intervention group

Conventional medial care group OTHER

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.

Conventional medial care group

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• patients older than 65 years and under 90 years
• patients who meet the criteria for the Asian Working Group for Sarcopenia (AWGS) 2019
• patients who had metabolic syndrome

You may not qualify if:

• patients with less than estimated glomerular filtration rate (eGFR) 30
• 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

Sponsors & Collaborators

• Seoul Bumin Hospital: lead
• National Evidence-Based Healthcare Collaborating Agency: collaborator

Study Sites (1)

Seoul Bumin Hospital

Seoul, 07590, South Korea

RECRUITING

Related Publications (6)

• 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.

  PMID: 30498820 BACKGROUND

• 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.

  PMID: 30312372 BACKGROUND

• 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: 32033882 BACKGROUND

• 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.

  PMID: 32743250 BACKGROUND

• 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.

  PMID: 28539168 BACKGROUND

• 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.

  PMID: 28935775 BACKGROUND

MeSH Terms

Conditions

Sarcopenia; Motor Activity

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Behavior

Study Officials

• Yongchan Ha, phD

  Bumin Hospital(Seoul)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yongchan Ha, phD

CONTACT

01085218328; hayongch@naver.com

Eunsuk Kim, bachelor

CONTACT

01089353081; unanhi@bumin.co.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The President of Seoul Bumin Hospital

Study Record Dates

• First Submitted: October 11, 2024
• First Posted: October 23, 2024
• Study Start: March 29, 2022
• Primary Completion: October 31, 2024
• Study Completion: December 31, 2024
• Last Updated: October 24, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)