UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040271 |
|---|---|
| Receipt number | 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 | 2024/09/10 00:24:00 |
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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)
kohkichi.morimoto@keio.jp
Public contact
Name of contact person
| 1st name | Ryunosuke |
| Middle name | |
| Last name | Mitsuno |
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
rmitsuno@keio.jp
Sponsor or person
Institute
Division of Endocrinology, Metabolism and Nephrology, Department of Internal Medicine, Keio University, School of Medicine
Institute
Department
Personal name
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)
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
Terminated
Date of protocol fixation
| 2020 | Year | 03 | Month | 02 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 30 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2025 | 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
| 2024 | Year | 09 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045941
