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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016155
Receipt No. 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

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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 Obsterics 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
Email 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
Email daihyou@ml.keio.jp

Sponsor
Institute Keio University School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018754

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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