UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040271
Receipt No. R000045941
Scientific Title Randomized controlled trial to evaluate the efficacy of exercise training on cognitive function in peritoneal dialysis patients
Date of disclosure of the study information 2020/04/30
Last modified on 2021/05/08

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Randomized controlled trial to evaluate the efficacy of exercise training on cognitive function in peritoneal dialysis patients
Acronym Exercise training in peritoneal dialysis patients
Scientific Title Randomized controlled trial to evaluate the efficacy of exercise training on cognitive function in peritoneal dialysis patients
Scientific Title:Acronym Exercise training in peritoneal dialysis patients
Region
Japan

Condition
Condition Peritoneal dialysis patients
Classification by specialty
Endocrinology and Metabolism Nephrology Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the effects of 24-week home-based exercise training on cognitive function in peritoneal dialysis patients. Primary endpoint includes cognitive function, and secondary endpoint includes executive function, aerobic capacity, muscle strength, quality of life, residual renal function and parameters associated with arteriosclerosis.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Cognitive function assessed by Japanese version of the Montreal Cognitive Assessment, evaluated 24 weeks after assignment.
Key secondary outcomes Executive function, aerobic capacity, muscle strength, quality of life, residual renal function and parameters associated with arteriosclerosis, evaluated 24 weeks after assignment.

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 Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 24-week home-based exercise training, including 20-30 minutes of aerobic exercise thrice-weekly and resistance training twice-weekly. Exercise intensity is determined by the result of major muscle testing at baseline and Borg scale. Aerobic exercise and resistance training are performed with the target of 40-60% of the peak oxygen uptake (VO2peak) and 70% of 1 repetition maximum (RM), respectively.
Interventions/Control_2 Not treatment
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
50 years-old <=
Age-upper limit
90 years-old >
Gender Male and Female
Key inclusion criteria 1) Peritoneal dialysis outpatients.
2) Patients from whom written informed consent was obtained.
Key exclusion criteria 1) Patients who are contraindicated for exercise training. Concrete criteria are as follows: patients with uncontrolled persistent hypertension (systolic blood pressure >= 180 mmHg or diastolic pressure >= 110 mmHg); severe anemia (Hb < 7 g/dL); active proliferative diabetic retinopathy; prior symptomatic coronary artery or cerebrovascular diseases within the previous 3 months; uncontrolled heart failure (NYHA >= III); symptomatic or lethal arrhythmia; severe valvular diseases; and walking difficulty due to orthopedic, cerebrovascular and peripheral artery diseases.

2) Unstable PD patients. Concrete criteria are as follows: patients who undergo PD less than 3 months and those with uncontrolled uremia (BUN > 100 mg/dL, K > 6.0 mEq/L and HCO3 < 18 mmoL/L).

3) Patients deemed inadequate for monitoring during study period, as determined by investigators.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Kohkichi
Middle name
Last name Morimoto
Organization Keio University, School of Medicine
Division name Apheresis and Dialysis Center
Zip code 160-8582
Address 35-banchi, Shinano-machi ,Shinjuku-ku,Tokyo, Japan
TEL +81-3-3353-1211(0535)
Email kohkichi.morimoto@keio.jp

Public contact
Name of contact person
1st name Takashin
Middle name
Last name Nakayama
Organization Department of internal medicine, Keio University, School of Medicine
Division name Division of Endocrinology, Metabolism and Nephrology
Zip code 160-8582
Address 35-banchi, Shinano-machi ,Shinjuku-ku,Tokyo, Japan
TEL +81-3-3353-1211(0535)
Homepage URL
Email takashin.nakayama@gmail.com

Sponsor
Institute Division of Endocrinology, Metabolism and Nephrology, Department of Internal Medicine, Keio University, School of Medicine
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Department of Nephrology, International University of Health and Welfare, School of Medicine
Name of secondary funder(s)

IRB Contact (For public release)
Organization Keio University School of Medicine Ethics Committee
Address 35-banchi, Shinano-machi ,Shinjuku-ku,Tokyo, Japan
Tel +81-3-3353-1211(62014)
Email med-rinri-jimu@adst.keio.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

Other administrative information
Date of disclosure of the study information
2020 Year 04 Month 30 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
2020 Year 03 Month 02 Day
Date of IRB
Anticipated trial start date
2020 Year 06 Month 01 Day
Last follow-up date
2022 Year 03 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
2020 Year 04 Month 29 Day
Last modified on
2021 Year 05 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045941

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.