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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020129
Receipt No. R000023253
Scientific Title Immediate effects of active supine exercise associated with compression therapy on lower limb lymphedema
Date of disclosure of the study information 2015/12/09
Last modified on 2019/03/03

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Basic information
Public title Immediate effects of active supine exercise associated with compression therapy on lower limb lymphedema
Acronym Immediate effects of active supine exercise associated with compression therapy on lower limb lymphedema
Scientific Title Immediate effects of active supine exercise associated with compression therapy on lower limb lymphedema
Scientific Title:Acronym Immediate effects of active supine exercise associated with compression therapy on lower limb lymphedema
Region
Japan

Condition
Condition Patients with lower limb lymphedema
Classification by specialty
Vascular surgery Plastic surgery Rehabilitation medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate immediate effects of active supine exercise associated with compression therapy on lower limb lymphedema
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Evaluation period:
Immediate pre -and - post intervention

Outcome: Lower limb volume
Key secondary outcomes Evaluation period:
Immediate pre -and - post intervention

1:Pain(Visual Analogue Scale (VAS))
2:Heaviness(Visual Analogue Scale (VAS))
3:Pitting or non-pitting
4:Skin stiffness

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment No need to know

Intervention
No. of arms 6
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 A: To pedal the ergometer in a seated position with compression therapy for 15 minutes - Wash out period (1 week) - B: To pedal the ergometer in a supine position with compression therapy for 15 minutes - Wash out period (1 week) - C: Both legs elevation in a rested position with compression therapy for 15 minutes
Interventions/Control_2 A: To pedal the ergometer in a seated position with compression therapy for 15 minutes - Wash out period (1 week) - C: Both legs elevation in a rested position with compression therapy for 15 minutes - Wash out period (1 week ) - B: To pedal the ergometer in a supine position with compression therapy for 15 minutes
Interventions/Control_3 B: To pedal the ergometer in a supine position with compression therapy for 15 minutes - Wash out period (1 week) - A: To pedal the ergometer in a seated position with compression therapy for 15 minutes - Wash out period (1 week) - C: Both legs elevation in a rested position with compression therapy for 15 minutes
Interventions/Control_4 B: To pedal the ergometer in a supine position with compression therapy for 15 minutes - Wash out period (1 week) - C: Both legs elevation in a rested position with compression therapy for 15 minutes - Wash out period (1 week) - A: To pedal the ergometer in a seated position with compression therapy for 15 minutes
Interventions/Control_5 C: Both legs elevation in a rested position with compression therapy for 15 minutes - Wash out period (1 week) - A: To pedal the ergometer in a seated position with compression therapy for 15 minutes - Wash out period (1 week) - B: To pedal the ergometer in a supine position with compression therapy for 15 minutes
Interventions/Control_6 C: Both legs elevation in a rested position with compression therapy for 15 minutes - Wash out period (1 week) - B: To pedal the ergometer in a supine position with compression therapy for 15 minutes - Wash out period (1 week) - A: To pedal the ergometer in a seated position with compression therapy for 15 minutes
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
80 years-old >
Gender Female
Key inclusion criteria Patients with lower limb lymphedema
Possible to perform active exercise
Informed consent by her own will
Key exclusion criteria Cellulitis, Lymphangitis, Erysipelas
Leakage of lymphatic fluid
Deep venous thrombosis and severe
Aneurysm
Poor general status
Fever (37.0 degrees C)
Sever heart disease
Pulmonary embolism, acute respiratory failure, sever pulmonary hypertension within the past 3 months
Sever hepatic or renal failure
Other metabolic disorder (acute thyroiditis etc.)
Pacemaker user
Target sample size 18

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 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL 03-5363-3833
Email cxa01423@nifty.com

Public contact
Name of contact person
1st name
Middle name
Last name Kiriko Abe
Organization Keio University Graduate School of Medicine
Division name Department of Rehabilitation Medicine
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL 03-5363-3833
Homepage URL
Email kirikirikiriko916@gmail.com

Sponsor
Institute Keio University, School of Medicine
Institute
Department

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
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 12 Month 09 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
2015 Year 12 Month 04 Day
Date of IRB
Anticipated trial start date
2016 Year 01 Month 25 Day
Last follow-up date
2019 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
2015 Year 12 Month 09 Day
Last modified on
2019 Year 03 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023253

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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