UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016155 |
|---|---|
| Receipt number | R000018754 |
| Scientific Title | Effect of Combined Physical Therapy for Patients with Lymphedema |
| Date of disclosure of the study information | 2015/01/08 |
| Last modified on | 2019/01/10 12:18:19 |
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Basic information
Public title
Effect of Combined Physical Therapy for Patients with Lymphedema
Acronym
Effect of CPT for Lymphedema
Scientific Title
Effect of Combined Physical Therapy for Patients with Lymphedema
Scientific Title:Acronym
Effect of CPT for Lymphedema
Region
| Japan |
Condition
Condition
Lymphedema
Classification by specialty
| Vascular surgery | Obstetrics and Gynecology | Rehabilitation medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effect of combined physical therapy for patients with lymphedema.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change of volume of lower extremity
Lymphedema severity score
Key secondary outcomes
QOL evaluation (SF-36, Euriqol)
Adverse event
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
6
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
group intensive combined physical therapy (feasibility study)
Interventions/Control_2
group maintenance combined physical therapy (feasibility study)
Interventions/Control_3
group of reinforcement of compression therapy (main study)
Interventions/Control_4
group of reinforcement of lymph-drainage therapy (main study)
Interventions/Control_5
group of reinforcement of exercise (main study)
Interventions/Control_6
standard therapy (main study)
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
1. primary secondary lymphedema of unilateral leg
2. patient without intensive combined physical therapy within three months
3. more than 20 years
Key exclusion criteria
1. edema due to other causes
2. edema of upper extremities or body
3. stage 0-lymphedema
cancer patient
4. expected life time less than one years
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | TETSUYA TSUJI |
Organization
Keio University School of Medicine
Division name
Department of Rehabilitation Medicine
Zip code
Address
Shinanomachi 35, Shinjuku-ku, Tokyo, Japan
TEL
03-5363-3833
daihyou@ml.keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | TETSUYA TSUJI |
Organization
Keio University School of Medicine
Division name
Department of Rehabilitation Medicine
Zip code
Address
Shinanomachi 35, Shinjuku-ku, Tokyo, Japan
TEL
03-5363-3833
Homepage URL
daihyou@ml.keio.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare of Japan
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
JAPAN
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
慶應義塾大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 01 | Month | 08 | 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
Completed
Date of protocol fixation
| 2014 | Year | 12 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 04 | Month | 15 | Day |
Date of closure to data entry
| 2015 | Year | 05 | Month | 01 | Day |
Date trial data considered complete
| 2016 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 01 | Month | 07 | Day |
Last modified on
| 2019 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018754
