UMIN-CTR Clinical Trial

Basic information
Public title	Is exercise for nephrotic syndrome safe and effective?
Acronym	Nephrotic syndrome test
Scientific Title	Verification of safety and efficacy of early exercise therapy intervention for acute nephrotic syndrome
Scientific Title:Acronym	Nephrotic syndrome test
Region	Japan

Condition
Condition	Nephrotic syndrome
Classification by specialty	Nephrology Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the effects of exercise therapy for patients with acute nephrotic syndrome on exercise tolerance, knee extension muscle strength and renal function.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase III

Assessment
Primary outcomes	Exercise tolerance(Before treatment,4 weeks after starting rehabilitation,8 weeks after starting rehabilitation)
Key secondary outcomes	Isometric knee extension muscle strength Skeletal muscle mass Walking speed Grip strength Depression(CES-D scale) Quality of life(SF-36) Nephrotic syndrome-related marker Renal function Presence of anemia Thrombosis related markers

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Pseudo-randomization

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	<Intervention group> Rehabilitation started 11 days after treatment or renal biopsy. Start exercise therapy immediately after rehabilitation. *Exercise therapy Conduct muscular strength training and endurance training 5 times a week, 40-60 minutes a day.
Interventions/Control_2	<Control group> Rehabilitation started 11 days after treatment or renal biopsy. Perform light load exercise immediately after rehabilitation. Start exercise therapy 4 weeks after starting rehabilitation.
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	75 years-old >=
Gender	Male and Female
Key inclusion criteria	1.Patients admitted to our hospital with nephrotic syndrome and starting or increasing steroid therapy. (Minimal change nephrotic syndrome, membranous nephropathy, focal segmental glomerulosclerosis, membranoproliferative glomerulonephritis, lupus nephritis) 2.ADL is independent
Key exclusion criteria	1.A person with a history of comorbid heart disease or pulmonary disease. 2.Those who cannot perform tests such as muscle strength measurement or appropriate exercise therapy due to orthopedic disease. 3.Those with unhealed cancer
Target sample size	25

Research contact person
Name of lead principal investigator	1st name Hideo Middle name Last name Yasuda
Organization	Hamamatsu University Hospital
Division name	First course of internal medicine (digestive organ, kidney, neurology)
Zip code	431-3192
Address	1-20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka, Japan
TEL	053-435-2111
Email	ysdh@hama-med.ac.jp

Public contact
Name of contact person	1st name Yuma Middle name Last name Hirano
Organization	Hamamatsu University Hospital
Division name	Department of Rehabilitation
Zip code	431-3192
Address	1-20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka, Japan
TEL	053-435-2111
Homepage URL
Email	yuma.h.pt@gmail.com

Sponsor
Institute	Hamamatsu 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	Ethics Committee of Hamamatsu University School of Medicine
Address	1-20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka, Japan
Tel	053-435-2680
Email	rinri@hama-med.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	浜松医科大学医学部附属病院(静岡)

Other administrative information
Date of disclosure of the study information	2019 Year 10 Month 10 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	2019 Year 10 Month 10 Day
Date of IRB
Anticipated trial start date	2019 Year 10 Month 20 Day
Last follow-up date	2021 Year 08 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	2019 Year 10 Month 09 Day
Last modified on	2019 Year 10 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043588