UMIN-CTR Clinical Trial

Basic information
Public title	Effect of exercise intervention on cognitive and physical function in pre-dialysis CKD patients: A randomized controlled trial
Acronym	Effect of exercise intervention for health in pre-dialysis CKD patients
Scientific Title	Effect of exercise intervention on cognitive and physical function in pre-dialysis CKD patients: A randomized controlled trial
Scientific Title:Acronym	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, ADMA 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	1st name Middle name Last name Naoto Tominaga
Organization	Kawasaki Municipal Tama Hospital
Division name	Division of Nephrology and Hypertension, Department of Internal Medicine
Zip code
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	1st name Middle name Last name Yuhei Otobe
Organization	Kawasaki Municipal Tama Hospital
Division name	Department of Rehabilitation medicine
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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	Completed
Date of protocol fixation	2018 Year 12 Month 01 Day
Date of IRB	2019 Year 06 Month 05 Day
Anticipated trial start date	2019 Year 07 Month 01 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry	2020 Year 05 Month 08 Day
Date trial data considered complete	2020 Year 06 Month 22 Day
Date analysis concluded	2020 Year 07 Month 10 Day

Other
Other related information

Management information
Registered date	2018 Year 12 Month 05 Day
Last modified on	2020 Year 12 Month 07 Day

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