UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Immediate effects of active exercise associated with compression therapy on lower limb lymphedema
Title of the study (Brief title)	Immediate effects of active 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 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	Lower limb volume
Key secondary outcomes	pain heaviness pitting or non-pitting 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	NO
Concealment	No need to know

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Compression therapy
Interventions/Control_2	Active exercise associated with compression therapy
Interventions/Control_3	Active exercise associated with compression therapy
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	80 years-old >=
Gender	Female
Key inclusion criteria	Patients with lower limb lymphedema Possible to perform active exercise Informed consent by his/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) Severe heart disease Pulmonary embolism, acute respiratory failure, severe pulmonary hypertension within the past 3 months Severe hepatic or renal failure Other metabolic disorders(acute thyroiditis etc.)
Target sample size	20

Research contact person
Name of lead principal investigator	Tetsuya Tsuji
Organization	Keio University, School of Medicine
Division name	Department of Rehabilitation Medicine
Address	35 Shinanomachi, Shinjukuku, Tokyo 160-8582, Japan
TEL	03-5363-3833
Email	cxa01423@nifty.com

Public contact
Name of contact person	Takuya Fukushima
Organization	Keio University Graduate School of Medicine
Division name	Department of Rehabilitation Medicine
Address	35 Shinanomachi, Shinjukuku, Tokyo 160-8582, Japan
TEL	03-5363-3833
Homepage URL
Email	takuyafukushima321@yahoo.co.jp

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)

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 02 Month 18 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 12 Month 11 Day
Anticipated trial start date	2014 Year 02 Month 18 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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 02 Month 18 Day
Last modified on	2017 Year 08 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015371