UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029372 |
|---|---|
| Receipt number | 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 | 2023/06/13 15:31:47 |
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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 | Naoshi |
| Middle name | |
| Last name | Horikawa |
Organization
Kawagoe Clinic, Saitama Medical University
Division name
The Department of Psychiatry
Zip code
350-1123
Address
21-7 Wakita-honcho, Kawagoe, Saitama, Japan
TEL
049-238-8111
nhorikawa@wa3.so-net.ne.jp
Public contact
Name of contact person
| 1st name | Naoshi |
| Middle name | |
| Last name | Horikawa |
Organization
Kawagoe Clinic, Saitama Medical University
Division name
The Department of Psychiatry
Zip code
350-1123
Address
21-7 Wakita-honcho, Kawagoe, Saitama, Japan
TEL
049-238-8111
Homepage URL
nhorikawa@wa3.so-net.ne.jp
Sponsor or person
Institute
The Department of Psychiatry, Kawagoe Clinic, Saitama Medical University
Institute
Department
Personal name
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
Misato Kenwa Clinic
Address
Takano 4-494-1, Misato, Saitama
Tel
048-955-8551
nakamura-taira@umin.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
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
https://www.tandfonline.com/doi/full/10.1080/21642850.2021.1966302
Publication of results
Published
Result
URL related to results and publications
https://www.tandfonline.com/doi/full/10.1080/21642850.2021.1966302
Number of participants that the trial has enrolled
42
Results
In depression, cognitive function, and the NPI-Q, there were no significant effects. In subjective insomnia, a short-term effect in the intervention group compared to the control group was found. However, the effect had disappeared by the 12-month follow-up. In exercise self-efficacy, short- and long-term effects were found. A significant short-term effect in the resistance exercise. However, the effect was weakened in the long term.
Results date posted
| 2021 | Year | 10 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Forty-two patients undergoing hemodialysis
Participant flow
Fifty-two participants who met the eligibility criteria were recruited, and forty-two participants participated in the program.
Adverse events
We had no adverse events.
Outcome measures
The Borg RPE measures, each patient's participation status ratings by staff members who observed the program, participants' impression of the exercise program, The Japanese version of the Patient Health Questionnaire-9 (PHQ-9), The Japanese version of the Montreal Cognitive Assessment (MoCA-J) , The Japanese version of the Athens Insomnia Scale (AIS), The Japanese version of the Neuropsychiatric Inventory-Brief Questionnaire Form (NPI-Q), modified Exercise self-efficacy (Oka, 2003), Measurements of physical abilities.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2017 | Year | 05 | Month | 20 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 28 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 01 | 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 | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 10 | Month | 02 | Day |
Last modified on
| 2023 | Year | 06 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033186
