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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000029372
Receipt No. R000033186
Scientific Title Effects of exercise training on depressive symptom and cognitive function in hemodialysis patients
Date of disclosure of the study information 2017/10/02
Last modified on 2017/10/24

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Basic information
Public title Effects of exercise training on depressive symptom and cognitive function in hemodialysis patients
Acronym Exercise training in hemodialysis patients
Scientific Title Effects of exercise training on depressive symptom and cognitive function in hemodialysis patients
Scientific Title:Acronym Exercise training in hemodialysis patients
Region
Japan

Condition
Condition hemodialysis patients
Classification by specialty
Nephrology Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In this study, we aim to examine the effects of 6-month exercise therapy in hemodialysis patients on the improvement of depressive symptoms and cognitive function.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes depressive symptom: PHQ-9
cognitive function: MoCA-J
pre-intervention, 3 months, 6 months, 12 months
Key secondary outcomes sleep quality: Athens insomnia scale
behavioral and psychological symptoms of dementia: NPI-Q(The Neuropsychiatric Inventory Questionnaire)
ADL: Barthel Index
Physical function: Knee Extension Muscle Strength, Weight Bearing Index, Grip Strength
pre-intervention, 3 months, 6 months, 12 months

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Pseudo-randomization

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 intervention group: exercise training during dialysis
control group: strtching during dialysis
Interventions/Control_2 intervention group: 6 months
control group: 6 months
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Hemodialysis 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 who were diagnosed with heart failure and whose subjective symptoms of heart failure worsened within the past week
-Patients with unstable angina pectoris
Myocardial ischemic patients with low threshold
-Patients who developed acute myocardial infarction within the past month
-Patients with severe left ventricular efflux stenosis (obstructive hypertrophic cardiomyopathy, etc.)
-Patients with untreated exercise-induced severe arrhythmia (ventricular fibrillation, sustained ventricular tachycardia)
-Patients with poorly controlled arrhythmia
-Patients with active myocarditis / pericarditis
-Patients with acute aortic dissection
-Patients with other disorders in which exercise therapy is contraindicated (moderate or higher degrees of aortic aneurysm, severe hypertension, thrombophlebitis, embolism within the past 2 weeks, severe multiple organ disorder, etc.)
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naoshi Horikawa
Organization Kawagoe Clinic, Saitama Medical University
Division name The Department of Psychiatry
Zip code
Address 21-7 Wakita-honcho, Kawagoe, Saitama, Japan
TEL 049-238-8111
Email nhorikawa@wa3.so-net.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naoshi Horikawa
Organization Kawagoe Clinic, Saitama Medical University
Division name The Department of Psychiatry
Zip code
Address 21-7 Wakita-honcho, Kawagoe, Saitama, Japan
TEL 049-238-8111
Homepage URL
Email nhorikawa@wa3.so-net.ne.jp

Sponsor
Institute The Department of Psychiatry, Kawagoe Clinic, Saitama Medical University
Institute
Department

Funding Source
Organization self funding
Organization
Division
Category of Funding Organization Self funding
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 みさと健和クリニック(埼玉県),三郷中央総合病院(埼玉県)

Other administrative information
Date of disclosure of the study information
2017 Year 10 Month 02 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 No longer recruiting
Date of protocol fixation
2017 Year 05 Month 20 Day
Date of IRB
Anticipated trial start date
2017 Year 08 Month 01 Day
Last follow-up date
2018 Year 12 Month 30 Day
Date of closure to data entry
2019 Year 01 Month 31 Day
Date trial data considered complete
2019 Year 02 Month 28 Day
Date analysis concluded
2019 Year 04 Month 30 Day

Other
Other related information

Management information
Registered date
2017 Year 10 Month 02 Day
Last modified on
2017 Year 10 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033186

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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