UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054255 |
|---|---|
| Receipt number | R000061880 |
| Scientific Title | Effects of combined neuromuscular electrical stimulation and aerobic exercise on exercise tolerance and microcirculation in patients with chronic heart failure. |
| Date of disclosure of the study information | 2024/04/30 |
| Last modified on | 2024/11/21 15:02:23 |
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Basic information
Public title
Effects of combined neuromuscular electrical stimulation and aerobic exercise on exercise tolerance and microcirculation in patients with chronic heart failure.
Acronym
Effects of combined neuromuscular electrical stimulation and aerobic exercise on exercise tolerance and microcirculation in patients with chronic heart failure.
Scientific Title
Effects of combined neuromuscular electrical stimulation and aerobic exercise on exercise tolerance and microcirculation in patients with chronic heart failure.
Scientific Title:Acronym
Effects of combined neuromuscular electrical stimulation and aerobic exercise on exercise tolerance and microcirculation in patients with chronic heart failure.
Region
| Japan |
Condition
Condition
heart failure
Classification by specialty
| Cardiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the efficacy of combined systemic neuromuscular electrical stimulation therapy and aerobic exercise in patients with heart failure.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
402(peak),402(AT)after 20 sessions from baseline
Key secondary outcomes
Body composition
Knee extenshion muscle strength
FMD
The amount of change in walking distance for 6 minutes
Blood sugar level
Lactic acid value
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Treatment group
Wear a power suit equipped with electrodes arranged to correspond to 14 muscles in total of 7 parts:abdominal rectus muscle,abdominal oblique muscle,biceps,triceps,gluteus maximus muscle,quadriceps,and hamstring.
Perform electrical stimulation at a frequency of 4Hz through electrodes.
The stimulation intensity is the maximum strength that can be tolerated.
Wear a power suits and do 20 sessions of aerobic exercise for 1 hour(30 minutes of gymnastics and 30 minutes of bicycle ergometer)once with the intensity of AT.
Interventions/Control_2
sham group
As with the treatment group,perform 20 sessions of 1 hour of aerobic execise(30 minutes of gymnastics and 30 minutes of bicycle ergometer)at the intensity of AT while wearing a power suit.
Electrical stimulation shall not be flowed.
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
| 40 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who are planning to be hospitalized for the purpose of cardiac rehabilitation or patients who are undergoing cardiac rehabilitation while in hospital
More than 400patients with NT-proBNT within 4 mounths before the start of the study
Patients with a 6-minute walking distance of less than 400m
Patients capable of ergometer load
Patients who are willing to perform exercise therapy and have obtained their own written consent to participate in the research
Key exclusion criteria
Patients who fall under the contraindications of NMES use when inserting a pacemaker(skeletal muscle electrical stimulation guidelines)
Patienta who fall under the contraindications of exercise therapy described in the mental rehaling guidelines
Patients with limb defects
Patients who have difficulty walking independently
Patients who have difficulty implementing NMES due to skin diseases,wounds,and itching
patients whose doctor in charge determined that it was inappropriate to participate in the research
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Megumi |
| Middle name | |
| Last name | Hoshiai |
Organization
Dokkyo Medical University Nikko Medical Center
Division name
cardiology vascular and nephrology
Zip code
3211298
Address
145-1 moritomo,Nikko City,Tochigi
TEL
0288237000
mimu.beam@gmail.com
Public contact
Name of contact person
| 1st name | Megumi |
| Middle name | |
| Last name | Hoshiai |
Organization
Dokkyo Medical University Nikko Medical Center
Division name
cardiology vascular and nephrology
Zip code
3211298
Address
145-1 moritomo,Nikko City,Tochigi
TEL
0288237000
Homepage URL
mimu.beam@gmail.com
Sponsor or person
Institute
Dokkyo Medical University Nikko Medical Center
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education,Culture,Sports,Science and Technology
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
Dokkyo Medical University Nikko Medical Center
Address
145-1 moritomo,Nikko City,Tochigi
Tel
0288-23-7000
rinshokenkyu@dokkyomed.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
獨協医科大学日光医療センター（栃木県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 04 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 01 | Month | 14 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 15 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 30 | 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
| 2024 | Year | 04 | Month | 25 | Day |
Last modified on
| 2024 | Year | 11 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061880
