UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014050 |
|---|---|
| Receipt number | R000016360 |
| Scientific Title | POWER (Post-operative walking rehabilitation enhances recovery) study |
| Date of disclosure of the study information | 2014/05/23 |
| Last modified on | 2015/06/23 18:03:54 |
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Basic information
Public title
POWER (Post-operative walking rehabilitation enhances recovery) study
Acronym
POWER study
Scientific Title
POWER (Post-operative walking rehabilitation enhances recovery) study
Scientific Title:Acronym
POWER study
Region
| Japan |
Condition
Condition
surgical patients who need more than 12 hours postoperative forced bed rest due to therapeutic requirement
Classification by specialty
| Surgery in general | Gastrointestinal surgery | Vascular surgery |
| Endocrine surgery | Breast surgery | Obstetrics and Gynecology |
| Oto-rhino-laryngology | Orthopedics | Urology |
| Oral surgery | Neurosurgery | Cardiovascular surgery |
| Plastic surgery | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify that postoperative early walking rehabilitation has how large preventing effect against disuse atrophy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
To measure thickness of the rectus femoris muscle using US at 5 pionts as follows, preoperative, postoperative day 1st,3rd,7th,and the day before discharge. And measure the round length of rectus femoris muscle at same time.
Key secondary outcomes
To evaluate the ability of daily living at discharge.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
surgical patients who are required more than 12hour forced bed rest due to therapeutic need
Key exclusion criteria
patients who refused the study entry
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masashi Nakagawa |
Organization
Kinan hospital
Division name
Dept. of anesthesiology
Zip code
Address
46-70 Shinjou-cho Tanabe City Wakayama 646-8588, Japan
TEL
81-739-22-5000
mnakagawa@kinan-hp.tanabe.wakayama.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masashi Nakagawa |
Organization
Kinan Hospital
Division name
Dept. of Anesthesiology
Zip code
Address
46-70 Shinjou-cho Tanabe City Wakayama 646-8588, Japan
TEL
81-739-22-5000
Homepage URL
mnakagawa@kinan-hp.tanabe.wakayama.jp
Sponsor or person
Institute
Kinan Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
Address
Tel
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
| 2014 | Year | 05 | Month | 23 | 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
Terminated
Date of protocol fixation
| 2014 | Year | 05 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 05 | Month | 23 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
examine the relationship between perioperative patient data and rectus femoris muscle volume. examine whether postoperative early rehabilitaion improves the muscle volume.
Management information
Registered date
| 2014 | Year | 05 | Month | 23 | Day |
Last modified on
| 2015 | Year | 06 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016360
