SarcopeniaNCT06654648
Combined Exercise and Nutrition Intervention for Sarcopenia
A study testing Combined exercise nutrition intervention group and Conventional medial care group in people with Sarcopenia, run by Seoul Bumin Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 90 years
- Conditions the study is for
- Sarcopenia
- What is being tested?
- Combined exercise nutrition intervention group and Conventional medial care group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteSouth Korea
- Study dates
- 29 Mar 2022to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 90 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Seoul Bumin Hospital
Seoul, 07590
YongChan Ha, MD, PhD, 82226205101, hychan@bumin.co.kr
EunSuk Kim, RN, 82226205127, unanhi@bumin.co.kr
About this study
Official title: 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
Read the 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.
- Conditions
- Sarcopenia
- Being tested
- Combined exercise nutrition intervention group, Conventional medial care group
- Keywords
- Sarcopenia, Older adults, Exercise, Nutrition, Standard intervention
- Medical subject headings
- Sarcopenia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined exercise nutrition intervention groupOther
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 groupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Combined exercise nutrition intervention group |
| Conventional medial care group | Active comparator | Conventional medical care service for 12weeks during intervention period. Receives: Other: Conventional medial care group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: [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
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.
Measured: [Time Frame: Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3)]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2024
- Study start29 Mar 2022
- Primary completion31 Oct 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 118 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul Bumin Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Evidence-Based Healthcare Collaborating Agency
- Responsible party
- Principal investigator, YongChan Ha, Seoul Bumin Hospital
- Investigators
- Yongchan Ha, phD, Principal investigator, Bumin Hospital(Seoul)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06654648
- Sponsor's protocol ID
- BMH 2022-03-020
- Status last verified
- Oct 2024
- First submitted
- 11 Oct 2024
- Last updated
- 24 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30498820Cruz-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.
PubMed 30312372Chen 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.
PubMed 32033882Jang 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.
PubMed 32743250Malafarina 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.
PubMed 28539168Nipp 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.
PubMed 28935775
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Exercise and Nutrition Intervention for Sarcopenia in Patients With Hip Fracture: CENTERS； A Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06654648
- Acronym / sponsor ID
- BMH 2022-03-020
- Conditions
- Sarcopenia
- Keywords
- Sarcopenia, Older adults, Exercise, Nutrition, Standard intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 118 participants (estimated)
- Lead sponsor
- Seoul Bumin HospitalUniversity, hospital or other
- Collaborators
- National Evidence-Based Healthcare Collaborating Agency
- Study start
- 29 Mar 2022 (actual)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 23 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combined exercise nutrition intervention group | Experimental | Other: Combined exercise nutrition intervention groupCustomized 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. |
| Conventional medial care group | Active comparator | Other: Conventional medial care groupConventional medical care service for 12weeks during intervention period. |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combined exercise nutrition intervention groupCombination 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. | Other | Combined exercise nutrition intervention group |
| Conventional medial care groupConventional 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. | Other | Conventional medial care group |
Primary outcome
5-times chair stand test
Time frame: [Time Frame: Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3)]
Change from baseline 5-times chair stand test to 12 weeks after assessment, measured by 5-times chair stand test
1 secondary outcome
Physical performance
Time frame: [Time Frame: Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3)]
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2024.
- Background: PubMed 30498820Dent 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.
- Background: PubMed 30312372Cruz-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.
- Background: PubMed 32033882Chen 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.
- Background: PubMed 32743250Jang 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.
- Background: PubMed 28539168Malafarina 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.
- Background: PubMed 28935775Nipp 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yongchan Ha, phD principal investigator
Bumin Hospital(Seoul)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined exercise nutrition intervention group and Conventional medial care group in people with Sarcopenia, run by Seoul Bumin Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yongchan Ha, phD (01085218328, hayongch@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
5-times chair stand test (time frame: [Time Frame: Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3)]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06654648, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2024.