UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031082 |
|---|---|
| Receipt number | R000034567 |
| Scientific Title | Effects of exercise program for patients with lower limb lymphedema: A randomized controlled trial |
| Date of disclosure of the study information | 2018/02/05 |
| Last modified on | 2018/01/31 16:28:52 |
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Basic information
Public title
Effects of exercise program for patients with lower limb lymphedema: A randomized controlled trial
Acronym
Exercise program in patients with lower limb lymphedema
Scientific Title
Effects of exercise program for patients with lower limb lymphedema: A randomized controlled trial
Scientific Title:Acronym
Exercise program in patients with lower limb lymphedema
Region
| Japan |
Condition
Condition
lymphedema
Classification by specialty
| Obstetrics and Gynecology | Plastic surgery | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to classify the effects of an exercise program for patients with lower limb lymphedema.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
lower-limb circumference, Health-Related Quality of Life
Key secondary outcomes
muscle mass, muscle strength, walking status (speed, walking stride, balance)
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
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Participants engaged in a three-month resistance exercise program in addition to the usual Complete Decongestive Therapy. The resistance exercise program consisted of stretching, resistance exercise, and cooling down.
Interventions/Control_2
Participants performed only the usual Complete Decongestive Therapy.
Interventions/Control_3
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
The participant inclusion criteria included (1) having undergone intrapelvic lymph node dissection, and (2) ISL stage II or III.
Key exclusion criteria
Exclusion criteria were (1) patients who had signs of inflammation, (2) patients who had restricted range of motion and paralysis, (3) patients who experienced cancer recurrence within six months of enrolling in this study, (4) patients who had vascular disease, (5) patients who had exhibited any neurologic signs, (6) patients whose native language was not Japanese, and (7) patients who could not communicate.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Chiharu Akazawa |
Organization
Osaka Medical College
Division name
Graduate School of Nursing,
Zip code
Address
7-6 Hatchonishimachi, Takatsuki, Osaka
TEL
+81-72-6831221
fon137@osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Risa Fukuda |
Organization
Kyoto College of Nursing
Division name
Faculty of Nursing
Zip code
Address
1-21 Mibuhigashitakada-cho, Nakagyo-ku, Kyoto
TEL
+81-75-3110123
Homepage URL
r_fukuda@kyotokango.ac.jp
Sponsor or person
Institute
Graduate School of Nursing, Osaka Medical College
Institute
Department
Personal name
Funding Source
Organization
Osaka Medical College
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Faculty of Nursing, Kyoto College of Nursing
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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 02 | Month | 05 | 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
Preinitiation
Date of protocol fixation
| 2017 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 02 | Month | 07 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 01 | Month | 31 | Day |
Last modified on
| 2018 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034567
