UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041061 |
|---|---|
| Receipt number | R000046894 |
| Scientific Title | The multidisciplinary aggressive nutritional therapy and enhanced rehabilitation improve acute functional recovery in patients with malnourished hip fracture patients |
| Date of disclosure of the study information | 2020/07/10 |
| Last modified on | 2020/07/10 12:56:30 |
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Basic information
Public title
Multidisciplinary intervention with nutrition and exercise for hip fracture patients
Acronym
Effectiveness of nutrition and exercise interventions for hip fracture patients
Scientific Title
The multidisciplinary aggressive nutritional therapy and enhanced rehabilitation improve acute functional recovery in patients with malnourished hip fracture patients
Scientific Title:Acronym
The multidisciplinary aggressive nutritional therapy and enhanced rehabilitation for hip fracture patients
Region
| Japan |
Condition
Condition
hip fracture
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the intervention of combined nutrition and exercise on functional recovery in patients with hip fractures.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
ADL
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
nutrition and rehabilitation intervention
Interventions/Control_2
nutrition and rehabilitation intervention(increased multidisciplinary conference and ward round)
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
| 105 | years-old | > |
Gender
Male and Female
Key inclusion criteria
hip fracture due to falling
required surgery to treatment
Key exclusion criteria
pathological fracture
conservative therapy
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Tatsuro |
| Middle name | |
| Last name | Inoue |
Organization
Niigata University of Health and Welfare
Division name
Department of Physical Therapy
Zip code
950-3198
Address
Shimamicho, Kitaku, Niigatashi, Niigata, 950-3198, Japan
TEL
0252574443
tatsuro-inoue@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Tatsuro |
| Middle name | |
| Last name | Inoue |
Organization
Niigata University of Health and Welfare
Division name
Department of Physical Therapy
Zip code
950-3198
Address
Shimamicho, Kitaku, Niigatashi, Niigata, 950-3198, Japan
TEL
0252574443
Homepage URL
tatsuro-inoue@nuhw.ac.jp
Sponsor or person
Institute
Kobe city Nishi-kobe medical center
Institute
Department
Personal name
Funding Source
Organization
non
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
Kobe city Nishi-kobe medical center
Address
5-7-1, Kojidai, Nishiku, Kobe, Hyogo, Japan
Tel
078-997-2200
reha@nmc-kobe.or.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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 07 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
163
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 03 | Month | 23 | Day |
Anticipated trial start date
| 2016 | Year | 01 | Month | 01 | 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
Management information
Registered date
| 2020 | Year | 07 | Month | 10 | Day |
Last modified on
| 2020 | Year | 07 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046894
