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 2024/03/28 18:45:57

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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)

Email

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


Email

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)

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

Enrolling by invitation

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 03 Month 28 Day



Link to view the page

Value
https://center6.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