UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of exercise program for patients with lower limb lymphedema: A randomized controlled trial
Title of the study (Brief title)	Exercise program in patients with lower limb lymphedema
Region	Japan

Condition
Condition	lymphedema
Classification by specialty	Obsterics 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	Chiharu Akazawa
Organization	Osaka Medical College
Division name	Graduate School of Nursing,
Address	7-6 Hatchonishimachi, Takatsuki, Osaka
TEL	+81-72-6831221
Email	fon137@osaka-med.ac.jp

Public contact
Name of contact person	Risa Fukuda
Organization	Kyoto College of Nursing
Division name	Faculty of Nursing
Address	1-21 Mibuhigashitakada-cho, Nakagyo-ku, Kyoto
TEL	+81-75-3110123
Homepage URL
Email	r_fukuda@kyotokango.ac.jp

Sponsor
Institute	Graduate School of Nursing, Osaka Medical College
Institute
Department

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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 11 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034567