UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000036180
Receipt number	R000041218
Scientific Title	Sarcopenia and malnutrition in fracture patients admitted to a rehabilitation hospital; investigation of related factors of Activity of Daily Living
Date of disclosure of the study information	2019/03/12
Last modified on	2022/09/13 22:13:48

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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

Orthopedic patients, bone fracture patients

Classification by specialty

Orthopedics Rehabilitation medicine

Classification by malignancy

Others

Genomic information

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 or person

Institute

National Center for Geriatrics and Gerontology

Institute

Department

Personal name

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

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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

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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041218