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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035150
Receipt No. R000040064
Official scientific title of the study Effect of exercise intervention on cognitive and physical function in pre-dialysis CKD patients: A randomized controlled trial
Date of disclosure of the study information 2018/12/05
Last modified on 2018/12/05

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Basic information
Official scientific title of the study Effect of exercise intervention on cognitive and physical function in pre-dialysis CKD patients: A randomized controlled trial
Title of the study (Brief title) Effect of exercise intervention for health in pre-dialysis CKD patients
Region
Japan

Condition
Condition CKD stages G3-4 patients
Classification by specialty
Nephrology Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We will investigate the effect of exercise intervention on cognitive and physical function in pre-dialysis CKD patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Changes in cognitive (global cognition, several cognitive domains) evaluated after a 24-week intervention.
Key secondary outcomes Physical (muscle strength, balance function, and gait speed) function, endothelial function, plasma brain-derived neurotrophic factor concentration, quality of life, depression status, and body composition evaluated after a 24-week intervention.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom Other
Interventions/Control_1 Patients in the exercise group will undergo stretching, resistance, and aerobic training once a week at our rehabilitation center and more than twice a week at home for 24 weeks. The intensity will be prescribed at about 60% of one repetition maximum in the resistance training, and the rating of perceived exertion (Borg scale) is 11 to 13 in the aerobic training.
Interventions/Control_2 No specific intervention
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
65 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with CKD stages G3 and 4 (estimated glomerular filtration rate, 15-59 mL/min/1.73m2)
Key exclusion criteria Gait assistance
Dementia
Receiving renal replacement therapy (RRT)
Planning to undergo RRT in 6 months
Arteriosclerosis obliterans with Fontaine classification stage 2 or higher
Exercise restriction by a medical doctor
Unstable angina pectoris
Poorly controlled diabetes mellitus
Inappropriate as participants judged by a medical doctor
Target sample size 60

Research contact person
Name of lead principal investigator Naoto Tominaga
Organization Kawasaki Municipal Tama Hospital
Division name Division of Nephrology and Hypertension, Department of Internal Medicine
Address 1-30-37, Shukugawara, Tama-ku, Kawasaki, Kanagawa
TEL +81-044-933-8111
Email tominaga@marianna-u.ac.jp

Public contact
Name of contact person Yuhei Otobe
Organization Kawasaki Municipal Tama Hospital
Division name Department of Rehabilitation medicine
Address 1-30-37, Shukugawara, Tama-ku, Kawasaki, Kanagawa
TEL +81-044-933-8111
Homepage URL
Email y-oto@marianna-u.ac.jp

Sponsor
Institute Kawasaki Municipal Tama Hospital
Division of Nephrology and Hypertension, Department of Internal Medicine
Institute
Department

Funding Source
Organization Other
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
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 12 Month 05 Day

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 12 Month 01 Day
Anticipated trial start date
2019 Year 04 Month 01 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 12 Month 05 Day
Last modified on
2018 Year 12 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040064

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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