UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000032501
Receipt No. 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 2018/05/24

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Middle name
Last name Atsuhiko Matsunaga
Organization Kitasato University
Division name Graduate School of Medical Sciences
Zip code
Address 1-15-1 Kitasato, Minami-ku, Sagamihara city, Kanagawa
TEL 042-778-9970
Email atsuhikonet@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Yuta Suzuki
Organization Kitasato University
Division name Graduate School of Medical Sciences
Zip code
Address 1-15-1 Kitasato, Minami-ku, Sagamihara city, Kanagawa
TEL 042-778-9081
Homepage URL
Email ap13322@st.kitasato-u.ac.jp

Sponsor
Institute Graduate School of Medical Sciences, Kitasato University
Institute
Department

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
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 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
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
2018 Year 05 Month 07 Day
Date of IRB
Anticipated trial start date
2018 Year 05 Month 09 Day
Last follow-up date
Date of closure to data entry
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
2018 Year 05 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034689

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.