UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037984 |
|---|---|
| Receipt number | R000043285 |
| Scientific Title | Combined effect of early nutritional therapy and rehabilitation for patients with acute exacerbation of chronic obstruc tive pulmonary disease |
| Date of disclosure of the study information | 2019/09/10 |
| Last modified on | 2023/10/30 22:25:50 |
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Basic information
Public title
Combined effect of early nutritional therapy and rehabilitation for patients with acute exacerbation of chronic obstruc tive pulmonary disease
Acronym
ENETAC trial
Scientific Title
Combined effect of early nutritional therapy and rehabilitation for patients with acute exacerbation of chronic obstruc tive pulmonary disease
Scientific Title:Acronym
efficacy of early nutrition and exercise therapy for AE-COPD:ENETAC trial
Region
| Japan |
Condition
Condition
acute exacerbation of chronic obstructive pulmonary disea se
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of early nutritional therapy on m otor function in patients with exacerbated chronic obstruct ive pulmonary disease who underwent early rehabilitation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
muscle strength of knee extensor
(after 2 weeks intervention)
Key secondary outcomes
Grip strength, 6-minute walking distance, Japanese Cardio vascular Health Study index, Short Physical Performance Battery, Serum total protein, Serum albumin, Geriatric Nutritional Risk Index, Blood lipid mediator
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
YES
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
nutritional therapy with rehabilitation which started within 72 hours after admission, nutritional therapy is performed.
The total energy expenditure is estimated by multiplying the basic energy expenditure using the Harris Benedict equation by the activity factor (1.3 to 1.5) and the stress factor (1.1 to 1.3), and added amount of energy expenditure when performing exercise therapy.
Interventions/Control_2
In addition to the rehabilitation which is started within 72 hours after admission, ordinary meals is supplied.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients with exacerbation of COPD who are hospitalization for treatment.
Key exclusion criteria
Patients who have difficulty in walking because of sensory disturbance, musculoskeletal disease and cerebrovascular disease.
Patients with malignancy who have not undergone radical treatment.
Patients with clinically diagnosed interstitial pneumonia.
Patients who take steroids usually before hospitalization.
Patients who have difficulty in walking alone because of visual impairment.
Patients who require special consideration such as writing for communication because of hearing impairment.
Patients who with dementia or delirium before hospitalization, who were not able to evaluate and intervention.
Patients who are determined to be inappropriate as research subjects by the investigators.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yoshiki |
| Middle name | |
| Last name | Masuda |
Organization
Sapporo Medical University
Division name
Graduate school of medicine, Department of Intensive Care Medicine,
Zip code
060-8543
Address
South 1, West 16, Chuo-ku, Sapporo, Hokkaido, Japan
TEL
011-611-2111
ymasuda@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | Yohei |
| Middle name | |
| Last name | Oyama |
Organization
JCHO Hokkaido Hospital
Division name
Department of Rehabilitation
Zip code
062-8618
Address
8-3-18, Nakanoshima 1, Toyohira-Ku, Sapporo, Hokkaido, Japan
TEL
011-831-5151
Homepage URL
oyama-youhei@hokkaido.jcho.go.jp
Sponsor or person
Institute
JCHO Hokkaido Hospital
Institute
Department
Personal name
Funding Source
Organization
Sapporo Medical University, Graduate school of medicine, Department of Intensive Care Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kobe university, Graduate school of medicine, the integrated center for mass spectrometry
Name of secondary funder(s)
IRB Contact (For public release)
Organization
JCHO Hokkaido Hospital, Institutional Review Board
Address
8-3-18, Nakanoshima 1, Toyohira-Ku, Sapporo, Hokkaido, Japan
Tel
011-831-5151
N/A
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
JCHO Hokkaido Hospital, Institutional Review Board
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 09 | 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
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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 07 | Month | 30 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 14 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 10 | Day |
Last follow-up date
| 2021 | Year | 08 | 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
| 2019 | Year | 09 | Month | 10 | Day |
Last modified on
| 2023 | Year | 10 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043285
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
| 2023/12/20 | 【ENETAC trial】dataset_UMIN-ICDR.xlsx |
