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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038250
Receipt No. R000043588
Scientific Title Verification of safety and efficacy of early exercise therapy intervention for acute nephrotic syndrome
Date of disclosure of the study information 2019/10/10
Last modified on 2019/10/09

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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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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