Combined Exercise and Nutrition Intervention for Sarcopenia

Combined Exercise and Nutrition Intervention for Sarcopenia in Patients With Hip Fracture: CENTERS； A Multicenter Randomized Controlled Trial

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

Study Overview

• Status: Recruiting
• Conditions: Sarcopenia
• Intervention / Treatment: Other: Combined exercise nutrition intervention group; Other: Conventional medial care group

Detailed Description

The definition of sarcopenia is age-related loss of skeletal muscle and physical functions.

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.

• Study Type: Interventional
• Enrollment (Estimated): 118
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yongchan Ha, phD; Phone Number: 01085218328; Email: hayongch@naver.com
• Study Contact Backup: Name: Eunsuk Kim, bachelor; Phone Number: 01089353081; Email: unanhi@bumin.co.kr

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 07590
    • Recruiting
    • Seoul Bumin Hospital
    • Contact: YongChan Ha, MD, PhD; Phone Number: 82226205101; Email: hychan@bumin.co.kr
    • Contact: EunSuk Kim, RN; Phone Number: 82226205127; Email: unanhi@bumin.co.kr
    • Principal Investigator: YongChan Ha, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional medial care group; Conventional medical care service for 12weeks during intervention period.	Other: 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.
Experimental: 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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical performance	Short Physical Performance Battery [range from 0 to 12 score] The scores range from 0 (worst performance) to 12 (best performance) with higher scores indicating better functionality. It is a group of measures that combines the results of the gait speed, chair stand and balance tests.	[Time Frame: Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3)]

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gait speed test	measured by 6 meter gait speed	[Time Frame: Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3)]
Appendicular skeletal muscle mass	measured using Dual-energy X-ray absorptiometry (DEXA)	[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	Evaluation of quality of life using EQ-5D [range from 5 to 25 score]. Higher value means worse quality of life	[Time Frame: Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3)]
Basic and instrumental activities of daily living	Evaluation of basic and instrumental activities of daily living using Korean Activity of Daily Living (K-ADL), Korean Instrumental Activity of Daily Living (K-IADL) [range from 0 to 33]. Low value means poor ability of activities.	[Time Frame: Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3)]
Sarcopenia screening questionnaire	Evaluation of quality of life using Strength, Assistance with walking, Rising from a chair, Climbing stairs and Falls (SARC-F) questionnair [range from 0 to 10] This questionnaire is named after the first letters of the five survey questions: strength, assistance in walking, rising from a chair, climbing stairs, and falls. The SARC-F questionnaire is a screening tool that can be rapidly implemented by clinicians to identify probable sarcopenic patients. The questionnaire screens patients for self-reported signs suggestive of sarcopenia, which include deficiencies in strength, walking, rising from a chair, climbing stairs, and experiencing falls. Each of the self-reported parameters receives a minimum and maximum score of 0 and 2, respectively, with the greatest maximum SARC-F score being 10 Grading method; Calculate the total score of the five questions answered by the subject.; Minimum 0 ~ Maximum 10 points; If the score is 4 or higher, sarcopenia is suspected.	[Time Frame: Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3)]
Nutritional Assessment(questionnaire)	1) Minimum nutritional assessment(MNA); Items: weight, weight (kg), exercise pad, nervous/mental problems, body mass index (kg/m2) Scoring: Add up a score between 0 and 3 for your answer to each question.; Items: residence, medication use, bedsore treatment, number of meals per day Scoring: Add up a score between 0 and 2 for your answer to each question.; ResultsMalnutrition indicator score Malnutrition: <17, Malnutrition Risk: 17-23.5 points, Normal: 24-30 points.Daily target protein(g/day)= g x body weight MNA 24-30 points (nutritious): 1.2 g/kg/day MNA 17-23.5 points (at risk): 1.5 g/kg/day MNA <17 points (malnutrition): 1.5 g/kg/day	[Time Frame: Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3)]
Nutritional Assessment(questionnaire)	2)Korean Protein Assessment Tool(KPAT) Check the average amount and frequency of meals and snacks consumed daily, weekly, and monthly through a questionnaire to determine the average amount of protein consumed per day(protein intake: g/day). 3)Nutrition counseling The protein deficiency(g/day) is calculated from the daily target protein intake (g/day) calculated from the MNA results and the daily protein intake(g/day) confirmed from the PIAT results. Nutritional counseling advises that insufficient protein intake be consumed through protein powder.	[Time Frame: Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3)]
Handgrip strength	Evaluation of hand grip strength using Hand-held dynamometer	[Time Frame: Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3)]
Delirium assessment	Evaluation of delirium using Delirium Rating Scale (DRS) [range from 0 to 32 score]. Higher value means worse delrious status	[Time Frame: Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3)]
Physical acitivity assessment	measured by Korean Physical Activity Scale for the Elderly (K-PASE) [range from 0 to 1382.52 score]. Higher value means better physical status	[Time Frame: Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3)]
Swallowing assessment	measured by Standardized Swallowing Assessment (SSA)	[Time Frame: Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3)]
Empowerment assessment	measured by Korean version of Health Empowerment Scale (K-HES) [range from 8 to 40 score]. Higher value means better empowerment status	[Time Frame: Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3)]
Cognitive assessment	Evaluation of cognitive state using Korean Mini Mental Status Examination, 2nd edition (K-MMSE2) [range from 0 to 30 score] Evaluate the subject's cognitive function by answering a total of 30 questions in 6 areas and performing test sentences. If the subject fails to provide an appropriate answer or fails to follow instructions, a score of 0 is given.; 0~17 points : obvious cognitive impairment; 18 to 23 points : Mild cognitive impairment; 24~30 points : No cognitive impairment	[Time Frame: Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3)]
Psychiatric state	Evaluation of psychiatric state using Short Form of Geriatric Depression Scale-Korea (SGDS-K) [range from 0 to 30 score]; 0~4 points : normal; 5~9 points : mild depression; 10 points or more : severe depression	[Time Frame: Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3)]

Collaborators and Investigators

• Sponsor: Seoul Bumin Hospital
• Collaborators: National Evidence-Based Healthcare Collaborating Agency
• Investigators: Principal Investigator: Yongchan Ha, phD, Bumin Hospital(Seoul)

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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. Erratum In: Age Ageing. 2019 Jul 1;48(4):601. doi: 10.1093/ageing/afz046.

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2022
• Primary Completion (Estimated): October 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: October 11, 2024
• First Submitted That Met QC Criteria: October 21, 2024
• First Posted (Actual): October 23, 2024

Study Record Updates

• Last Update Posted (Actual): October 24, 2024
• Last Update Submitted That Met QC Criteria: October 22, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Exercise; Nutrition; Sarcopenia; Older adults; Standard intervention
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Sarcopenia
• Other Study ID Numbers: BMH 2022-03-020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No