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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 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

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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name