UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032501 |
|---|---|
| Receipt number | R000034689 |
| Scientific Title | Effects of Electrical Muscle Stimulation in Frail Elderly Patients during Hemodialysis (DIAL): A Crossover Randomized Controlled Trial |
| Date of disclosure of the study information | 2018/05/07 |
| Last modified on | 2023/05/12 10:25:53 |
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Basic information
Public title
Effects of Electrical Muscle Stimulation in Frail Elderly Patients during Hemodialysis (DIAL): A Crossover Randomized Controlled Trial
Acronym
Effects of Electrical Muscle Stimulation in Frail Elderly Patients during Hemodialysis (DIAL Trial)
Scientific Title
Effects of Electrical Muscle Stimulation in Frail Elderly Patients during Hemodialysis (DIAL): A Crossover Randomized Controlled Trial
Scientific Title:Acronym
Effects of Electrical Muscle Stimulation in Frail Elderly Patients during Hemodialysis (DIAL Trial)
Region
| Japan |
Condition
Condition
Frail elderly patients undergoing hemodialysis
Classification by specialty
| Cardiology | Nephrology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of electrical muscle stimulation in frail elderly patients undergoing hemodialysis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Quadriceps Isometric Strength
Key secondary outcomes
Physical function, Physical activity, Cognitive function, Depressive symptoms, ADL performance, QOL, Dialysis situation, and other adverse events
Base
Study type
Interventional
Study design
Basic design
Cross-over
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
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Electrical muscle stimulation for 30-40 minutes per day, 3 days per week, 5 weeks during hemodialysis
Interventions/Control_2
Usual dialysis 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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Outpatients with chronic kidney disease undergoing maintenance hemodialysis therapy at 3 times a week
2) Aged 65 years or older
3) Frail patients (Short Physical Performance Battery score 4-9)
Key exclusion criteria
1)Cognitive dysfunction
2)Significant myocardial ischemia during low-intensity exercise
3)Resting heart rate > 120/min
4)Presence of a recent hospitalization (< 3 month)
5)Resting blood pressure > 180 mmHg
6)Ongoing orthopnea
7)Patients with inadequate oxygenation
8)Patients with uncontrolled diabetes
9)Recent embolism
10)Recent cardiovascular events
11)Recent bone fracture(<1 year)
12)Skin abnormality at adaptive site
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Atsuhiko |
| Middle name | |
| Last name | Matsunaga |
Organization
Kitasato University
Division name
Graduate School of Medical Sciences
Zip code
252-0373
Address
1-15-1 Kitasato, Minami-ku, Sagamihara city, Kanagawa
TEL
042-778-9970
atsuhikonet@gmail.com
Public contact
Name of contact person
| 1st name | Yuta |
| Middle name | |
| Last name | Suzuki |
Organization
Kitasato University
Division name
Graduate School of Medical Sciences
Zip code
252-0373
Address
1-15-1 Kitasato, Minami-ku, Sagamihara city, Kanagawa
TEL
042-778-9081
Homepage URL
szk.yutaf@gmail.com
Sponsor or person
Institute
Graduate School of Medical Sciences, Kitasato University
Institute
Department
Personal name
Funding Source
Organization
Graduate School of Medical Sciences, Kitasato University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Sagami Circulatory Organ Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
School of Allied Health Sciences, Kitasato University
Address
1-15-1 Kitasato, Minami-ku, Sagamihara city, Kanagawa
Tel
03-5791-9603
matsunao@kitasato-u.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
さがみ循環器クリニック（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 05 | Month | 07 | 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
18
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
| 2018 | Year | 05 | Month | 07 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 09 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 09 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 05 | Month | 07 | Day |
Last modified on
| 2023 | Year | 05 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034689
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