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

Email

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


Email

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


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



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name