UMIN-CTR Clinical Trial

Basic information
Public title	Sarcopenia and malnutrition in fracture patients admitted to a rehabilitation hospital; investigation of related factors of Activity of Daily Living
Acronym	Investigation of related factors of Activity of Daily Living in a rehabilitation hospital
Scientific Title	Sarcopenia and malnutrition in fracture patients admitted to a rehabilitation hospital; investigation of related factors of Activity of Daily Living
Scientific Title:Acronym	Investigation of related factors of Activity of Daily Living in a rehabilitation hospital
Region	Japan

Condition
Condition	Orthopedic patients, bone fracture patients
Classification by specialty	Orthopedics Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluate sarcopenia and nutritional status for fracture patients admitted to a rehabilitation hospital. Analysis of related factors that ADL ability and falls after discharge
Basic objectives2	Others
Basic objectives -Others	Observational study during hospitalization
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	FIM (Functional Independent Measure)
Key secondary outcomes	Basic information: body mass index (BMI), medical history, need of care, family living together, exercise habits, smoking and drinking history, falls experience Muscle mass: Bio impedance Analysis method (BIA) using Inbody S10 Blood data: Alb, T-CHO, TLC, CRP, Hb Mini Nutritional Assessment (MNA) Kihon Check List (KCL) Physical function: walking speed, Timed Up and Go test (TUG), One leg standing, Knee extension strength, Grip strength Mini-Mental State Examination (MMSE) Geriatric Depression Scale (GDS)

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	65 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	The main disease is orthopedic disease, fracture (femoral neck fracture, lumbar compression fracture, etc.) General condition is stable Patients who obtained informed consent for participation in this study
Key exclusion criteria	Motor paralysis and higher brain dysfunction due to cerebrovascular disease Physically and mentally severe condition due to malignant tumors and severe dementia Bedridden at the end of the disease Peripheral vascular disease with intermittent claudication Acute arthritis Severe chronic obstructive pulmonary disease heart failure (New York Heart Association (NYHA) stage 3 or 4) specific myopathy Bio impedance Analysis (BIA) contraindications (Ex. Cardiac pacemaker)
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Izumi Middle name Last name Kondo
Organization	National Center for Geriatrics and Gerontology
Division name	Rehabilitation Center
Zip code	474-8511
Address	7-430, Moriokacho, Obu-shi, Aichi, 474-8511, Japan
TEL	0562-46-2311
Email	ik7710@ncgg.go.jp

Public contact
Name of contact person	1st name Izumi Middle name Last name Kondo
Organization	National Center for Geriatrics and Gerontology
Division name	Rehabilitation Center
Zip code	474-8511
Address	7-430, Moriokacho, Obu-shi, Aichi, 474-8511, Japan
TEL	0562-46-2311
Homepage URL
Email	ik7710@ncgg.go.jp

Sponsor
Institute	National Center for Geriatrics and Gerontology
Institute
Department

Funding Source
Organization	self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	National Center for Geriatrics and Gerontology
Address	7-430, Moriokacho, Obu-shi, Aichi, 474-8511, Japan
Tel	0562-46-2311
Email	ik7710@ncgg.go.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	国立長寿医療研究センター

Other administrative information
Date of disclosure of the study information	2019 Year 03 Month 12 Day

Related information
URL releasing protocol	https://kaken.nii.ac.jp/grant/KAKENHI-PROJECT-19K19939/
Publication of results	Partially published

Result
URL related to results and publications	https://kaken.nii.ac.jp/grant/KAKENHI-PROJECT-19K19939/
Number of participants that the trial has enrolled	85
Results	The participants were 85 older patients (61 women, 24 men; mean age 80.2). The prevalence of sarcopenia was 49% (42 people) at admission and 46% (39 people) at discharge. As a result of multivariate analysis, factors related to sarcopenia at admission were age, BMI, and FIM (odds ratio; 1.15, 0.61, 0.94).The possibility of sarcopenia at admission was estimated high in the case of high age, low BMI, and low ADL.
Results date posted	2020 Year 02 Month 17 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Eighty-five patients (mean age 80.2 years) were included in the study. The prevalence of sarcopenia and the risk of malnutrition at admission and discharge were 49% and 46%, respectively, according to AWGS2019 criteria, and the percentage of malnutrition according to GLIM criteria was 51% and 54%, respectively, at admission and discharge, with more than 40% of patients leaving the hospital with residual sarcopenia and malnutrition risk. More than 40% of the patients left the hospital with residual risk of sarcopenia and low nutrition.
Participant flow	Patients who were 65 years of age or older, had a musculoskeletal disorder (e.g., femoral neck fracture, lumbar vertebrae compression fracture) as their primary disease, and had an understanding of the content of the study and agreed to participate in it. Patients with motor paralysis due to a history of cerebrovascular disease, patients with higher brain dysfunction or severe dementia who had difficulty understanding the study, and patients with contraindications to Bio Impedance Analysis (BIA) (e.g., implanted cardioverter-defibrillator) were excluded.
Adverse events	none
Outcome measures	Basic information: body mass index (BMI), medical history, need of care, family living together, exercise habits, smoking and drinking history, falls experience Muscle mass: Bio impedance Analysis method (BIA) using Inbody S10 Blood data: Alb, T-CHO, TLC, CRP, Hb Mini Nutritional Assessment (MNA) Kihon Check List (KCL) Physical function: walking speed, Timed Up and Go test (TUG), One leg standing, Knee extension strength, Grip strength Mini-Mental State Examination (MMSE) Geriatric Depression Scale (GDS)
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 02 Month 28 Day
Date of IRB	2018 Year 02 Month 28 Day
Anticipated trial start date	2018 Year 04 Month 03 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Evaluate sarcopenia and nutritional status for fracture patients admitted to a rehabilitation hospital. Analysis of related factors that ADL ability and falls after discharge

Management information
Registered date	2019 Year 03 Month 12 Day
Last modified on	2022 Year 09 Month 13 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041218