Unique ID issued by UMIN | UMIN000038250 |
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Receipt number | 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 14:22:40 |
Is exercise for nephrotic syndrome safe and effective?
Nephrotic syndrome test
Verification of safety and efficacy of early exercise therapy intervention for acute nephrotic syndrome
Nephrotic syndrome test
Japan |
Nephrotic syndrome
Nephrology | Rehabilitation medicine |
Others
NO
To clarify the effects of exercise therapy for patients with acute nephrotic syndrome on exercise tolerance, knee extension muscle strength and renal function.
Safety,Efficacy
Confirmatory
Phase III
Exercise tolerance(Before treatment,4 weeks after starting rehabilitation,8 weeks after starting rehabilitation)
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
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
NO
Institution is not considered as adjustment factor.
YES
Pseudo-randomization
2
Treatment
Maneuver |
<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.
<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.
20 | years-old | <= |
75 | years-old | >= |
Male and Female
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
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
25
1st name | Hideo |
Middle name | |
Last name | Yasuda |
Hamamatsu University Hospital
First course of internal medicine (digestive organ, kidney, neurology)
431-3192
1-20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka, Japan
053-435-2111
ysdh@hama-med.ac.jp
1st name | Yuma |
Middle name | |
Last name | Hirano |
Hamamatsu University Hospital
Department of Rehabilitation
431-3192
1-20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka, Japan
053-435-2111
yuma.h.pt@gmail.com
Hamamatsu University School of Medicine
None
Self funding
Ethics Committee of Hamamatsu University School of Medicine
1-20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka, Japan
053-435-2680
rinri@hama-med.ac.jp
NO
浜松医科大学医学部附属病院(静岡)
2019 | Year | 10 | Month | 10 | Day |
Unpublished
Preinitiation
2019 | Year | 10 | Month | 10 | Day |
2019 | Year | 10 | Month | 20 | Day |
2021 | Year | 08 | Month | 31 | Day |
2019 | Year | 10 | Month | 09 | Day |
2019 | Year | 10 | Month | 09 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043588
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