UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038344 |
|---|---|
| Receipt number | R000043700 |
| Scientific Title | Effects of nutritional supplementation on nutritional status improvement in the convalescent rehabilitation ward |
| Date of disclosure of the study information | 2019/10/21 |
| Last modified on | 2022/09/16 19:51:34 |
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Basic information
Public title
Effects of nutritional supplementation on nutritional status improvement in the convalescent rehabilitation ward
Acronym
Effects of nutritional supplements in the convalescent rehabilitation ward
Scientific Title
Effects of nutritional supplementation on nutritional status improvement in the convalescent rehabilitation ward
Scientific Title:Acronym
Effects of nutritional supplements in the convalescent rehabilitation ward
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
To explore the effects of nutritional supplements on nutritional status, psychosomatic function, and physical activity in patients in the convalescent rehabilitation ward
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Alb(Serum albumin)
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: TLC, T-CHO, TP, CRP, Hb, Cre
Mini Nutritional Assessment (MNA)
International standards for undernutrition (GLIM criteria; 2018)
Kihon Check List (KCL)
Physical function: walking speed, Timed Up and Go test (TUG), One leg standing, Knee extension strength, Grip strength
Physical activity evaluation; 3-axis accelerometer Lifecoder GS (manufactured by Suzuken)
FIM (Functional Independent Measures)
Mini-Mental State Examination (MMSE)
Geriatric Depression Scale (GDS)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
In addition to usual convalescent rehabilitation and nutritional management, take 4g of nutrient (amino feel) twice a day
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)
Kidney disease (CKD stage3 or higher)
Milk component allergy
Moderate or higher obesity (BMI>=30)
Uncontrolled diabetes mellitus
Target sample size
50
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
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
ik7710@ncgg.go.jp
Sponsor or person
Institute
National Center for Geriatrics and Gerontology
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
National Center for Geriatrics and Gerontology Ethics and Conflict of Interest Committee
Address
7-430, Moriokacho, Obu-shi, Aichi, 474-8511, Japan
Tel
0562-46-2311
rehab@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（愛知県）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 10 | Month | 21 | Day |
Related information
URL releasing protocol
https://kaken.nii.ac.jp/ja/grant/KAKENHI-PROJECT-19K19939/
Publication of results
Partially published
Result
URL related to results and publications
https://kaken.nii.ac.jp/ja/grant/KAKENHI-PROJECT-19K19939/
Number of participants that the trial has enrolled
42
Results
Patients with musculoskeletal disease admitted to a rehabilitation ward received 6 g/day of Branched Chain Amino Acids in addition to exercise. Sarcopenia and nutrition status were assessed at admission, discharge, and one month after discharge. There were 42 subjects (mean age 80.3 years), the prevalence of sarcopenia was 36% at admission, 38% discharge and 18% one month after discharge, and low nutrition was 55% at admission, 51% discharge and 42% one month after discharge.
Results date posted
| 2020 | Year | 02 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2021 | Year | 01 | Month | 27 | Day |
Baseline Characteristics
Forty-two patients (mean age 80.3 years) were analyzed, and the mean length of stay was 47.7+-16.8 days. The prevalence of sarcopenia was 36% at admission, 38% at discharge, and 18% one month after discharge, and the percentage of low nutrition was 55% at admission, 51% at discharge, and 42% one month after discharge.
Participant flow
Of the 504 patients admitted to the recovery ward during the study period (November 2019 to March 2022), 221 patients with musculoskeletal disease, 42 of whom were excluded from the study, including those under 65 years of age, with a history of cerebrovascular disease or severe dementia, and who gave consent to participate in the study.
Adverse events
none
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 10 | Month | 15 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 15 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 02 | Month | 28 | Day |
Date trial data considered complete
| 2022 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 08 | Month | 31 | Day |
Other
Other related information
The first case was registered on November 1, 2019, and evaluation and intervention have started. As of September 30, 2020, 21 cases have been enrolled and the intervention has been implemented.
Management information
Registered date
| 2019 | Year | 10 | Month | 20 | Day |
Last modified on
| 2022 | Year | 09 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043700
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
