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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000030357
Receipt No. R000034539
Scientific Title Randomized Cross-over Trial about immediate effects of manual lymphatic drainage and active supine exercise associated with compression therapy on lower limb lymphedema
Date of disclosure of the study information 2017/12/18
Last modified on 2019/06/19

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Basic information
Public title Randomized Cross-over Trial about immediate effects of manual lymphatic drainage and active supine exercise associated with compression therapy on lower limb lymphedema
Acronym Comparative study of immediate effects of MLD and active supine exercise associated with compression therapy on lower limb lymphedema
Scientific Title Randomized Cross-over Trial about immediate effects of manual lymphatic drainage and active supine exercise associated with compression therapy on lower limb lymphedema
Scientific Title:Acronym Comparative study of immediate effects of MLD and active supine exercise associated with compression therapy on lower limb lymphedema
Region
Japan

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

Objectives
Narrative objectives1 To evaluate immediate effects of manual lymphatic drainage and active supine exercise associated with compression therapy on secondary 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
5:Segmental Water Analysis, Segmental Lean Analysis

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are 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:MLD by well-experienced single lymphedema therapist for 30 minutes - Wash out period (1 week) - B: To pedal the ergometer in a supine position with compression therapy for 30 minutes - Wash out period (1 week) - C: Both legs elevation in a rested position for 30 minutes
Interventions/Control_2 A:MLD by well-experienced single lymphedema therapist for 30 minutes - Wash out period (1 week) - C: Both legs elevation in a rested position for 30 minutes- Wash out period (1 week) - B: To pedal the ergometer in a supine position with compression therapy for 30 minutes
Interventions/Control_3 B: To pedal the ergometer in a supine position with compression therapy for 30 minutes - Wash out period (1 week) - A:MLD by well-experienced single lymphedema therapist for 30 minutes - Wash out period (1 week) -C: Both legs elevation in a rested position for 30 minutes
Interventions/Control_4 B: To pedal the ergometer in a supine position with compression therapy for 30 minutes - Wash out period (1 week) - C: Both legs elevation in a rested position for 30 minutes- Wash out period (1 week) -A: MLD by well-experienced single lymphedema therapist for 30 minutes
Interventions/Control_5 C: Both legs elevation in a rested position for 30 minutes- Wash out period (1 week) - A:MLD by well-experienced single lymphedema therapist for 30 minutes - Wash out period (1 week) - B: To pedal the ergometer in a supine position with compression therapy for 30 minutes
Interventions/Control_6 C: Both legs elevation in a rested position for 30 minutes- Wash out period (1 week) - B: To pedal the ergometer in a supine position with compression therapy for 30 minutes - Wash out period (1 week) - A: MLD by well-experienced single lymphedema therapist for 30 minutes
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
85 years-old >=
Gender Female
Key inclusion criteria Patients with secondary lower limb lymphedema(ISL grade at least 2)
Possible to perform active exercise
Informed consent by her own will
Key exclusion criteria Cellulitis
Leakage of lymphatic fluid
Deep venous thrombosis and severe
Aneurysm
Inguinal lymph nodes metastasis
Poor general status
Fever (greater than 38.0 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 25

Research contact person
Name of lead principal investigator
1st name Tetsuya
Middle name
Last name Tsuji
Organization Keio University, School of Medicine
Division name Department of Rehabilitation Medicine
Zip code 160-8582
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 Asako
Middle name
Last name OKA
Organization Keio University, School of Medicine
Division name Department of Rehabilitation Medicine
Zip code 160-8582
Address 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL 03-5363-3833
Homepage URL
Email a-oka@keio.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)

IRB Contact (For public release)
Organization Keio University School of Medicine Ethics Committee
Address 35 Shinanomachi, Shinjyuku-ku, Tokyo
Tel 03-5363-3961
Email med-rinri-jimu@adst.keio.ac.jp

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
2017 Year 12 Month 18 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 24
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 No longer recruiting
Date of protocol fixation
2017 Year 12 Month 11 Day
Date of IRB
2017 Year 12 Month 10 Day
Anticipated trial start date
2018 Year 01 Month 10 Day
Last follow-up date
2021 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
2017 Year 12 Month 11 Day
Last modified on
2019 Year 06 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034539

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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