UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020129 |
|---|---|
| Receipt number | 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 17:59:40 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
kirikirikiriko916@gmail.com
Sponsor or person
Institute
Keio University, School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023253
