UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051167 |
|---|---|
| Receipt number | R000058346 |
| Scientific Title | Validation of a Remote Program for Home Exercise Support Using Internet of Things Devices in Elderly Dialysis Patients |
| Date of disclosure of the study information | 2023/06/30 |
| Last modified on | 2023/05/25 21:21:44 |
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Basic information
Public title
Validation of a Remote Program to Support Home Exercise in Elderly Dialysis Patients
Acronym
Program Validation for Dialysis Patients
Scientific Title
Validation of a Remote Program for Home Exercise Support Using Internet of Things Devices in Elderly Dialysis Patients
Scientific Title:Acronym
Program Validation for Dialysis Patients
Region
| Japan |
Condition
Condition
chronic renal disease
Classification by specialty
| Nephrology | Rehabilitation medicine | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Validation of a program to remotely support elderly chronic hemodialysis patients in strengthening their daily activities and physical exercise
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Physical function (grip strength, knee extension muscle strength)
Evaluation period (3 times): pre-intervention, 3 months post-intervention, and 6 months post-intervention
Key secondary outcomes
Automatic measurement by Fitbit (number of steps, distance walked, energy expenditure, physical activity time, heart rate, sleep duration, skin temperature during sleep), age, gender, height, primary diseases, comorbidities, smoking, use of antihypertensive medications and sleeping pills, body weight (dry weight), creatinine, urea nitrogen (BUN), potassium (K), calcium (Ca), phosphorus (P), albumin (Alb), hemoglobin (Hb), C reactive protein (CRP), standardized protein catabolic rate (n-PCR), % creatinine production rate, quality of life, performance of daily activities
Evaluation period (3 times): pre-intervention, 3 months post-intervention, and 6 months post-intervention.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Feedback of step data
Goal setting for number of steps
Linguistic praise
Interventions/Control_2
No intervention
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Undergoing chronic hemodialysis therapy three times a week by commuting from home
Able to walk independently
Age 65 and older
Have cognitively intact cohabitant(s) (any number of people)
Obtained written consent from participants and their cohabitant(s).
Key exclusion criteria
Less than 6 months after commencement hemodialysis
Unstable hemodialysis therapy condition
Difficult-to-treat hypertension, cardiac disease, and lower extremity arterial lesions
Active infectious diseases
advanced malignant disease
Patients deemed inappropriate for this study by the principal researcher or physician in charge
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Itoko |
| Middle name | |
| Last name | Tobita |
Organization
Osaka Medical and Pharmaceutical University
Division name
Faculty of Nursing
Zip code
569-0095
Address
7-6 Hatchonishimachi Takatsuki Osaka, JAPAN
TEL
072-684-7024
itoko.tobita@ompu.ac.jp
Public contact
Name of contact person
| 1st name | Itoko |
| Middle name | |
| Last name | Tobita |
Organization
Osaka Medical and Pharmaceutical University
Division name
Faculty of Nursing
Zip code
569-0095
Address
7-6 Hatchonishimachi Takatsuki Osaka, JAPAN
TEL
072-684-7024
Homepage URL
itoko.tobita@ompu.ac.jp
Sponsor or person
Institute
Osaka Medical and Pharmaceutical University
Institute
Department
Personal name
Funding Source
Organization
MEXT
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Promotion Section, Osaka Medical and Pharmaceutical University
Address
7-6 Daigakumachi Takatsuki Osaka, JAPAN
Tel
072-683-1221
rinri@ompu.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
| 2023 | Year | 06 | 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
| 2023 | Year | 05 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2026 | 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
| 2023 | Year | 05 | Month | 25 | Day |
Last modified on
| 2023 | Year | 05 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058346
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
