UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055211 |
|---|---|
| Receipt number | R000039983 |
| Scientific Title | A study on the effect of skeletal muscle electrical stimulation therapy in patients with ambulatory heart disease |
| Date of disclosure of the study information | 2024/08/13 |
| Last modified on | 2024/08/09 20:07:31 |
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Basic information
Public title
A study on the effect of skeletal muscle electrical stimulation therapy in patients with ambulatory heart disease
Acronym
CRSM
Scientific Title
A study on the effect of skeletal muscle electrical stimulation therapy in patients with ambulatory heart disease
Scientific Title:Acronym
CRSM
Region
| Japan |
Condition
Condition
Heart disease
Classification by specialty
| Cardiology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examination of combined effects of skeletal muscle electrical stimulation therapy and exercise therapy in patients with ambulatory heart diseaseExamination of combined effects of skeletal muscle electrical stimulation therapy and exercise therapy in patients with ambulatory heart disease
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
knee extension muscle force,anaerobic threshold,maximum oxygen uptake
Key secondary outcomes
Walking speed, balance function
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
In the intervention group, skeletal muscle stimulation therapy and exercise therapy using Panasonic knee trainer (EU - JLM 50 S) are used in combination. Contents of exercise therapy will be carried out 2 minutes of aerobic exercise with an anaerobic metabolic threshold using Senoh cordless bike V after preparatory exercise for 10 minutes before exercise.
Interventions/Control_2
The control group carries out ordinary exercise therapy.
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Heart disease patients who participate in outpatient exercise therapy more than twice a week
Key exclusion criteria
Visit frequencies twice a week
The following patients, patients with advanced orthopedic disease or advanced paralysis and bicycle ergometer can not be performed
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Masami |
| Middle name | |
| Last name | Inokuma |
Organization
Gunma Prefectural Cardiovascular Center
Division name
Division of Rehabilitation Medicine
Zip code
371-004
Address
3-12 Kou, Kameizumi-cho, Maebashi, Gunma
TEL
0272697455
inokuma-m@cvc.pref.gunma.jp
Public contact
Name of contact person
| 1st name | Masami |
| Middle name | |
| Last name | Inokuma |
Organization
Gunma Prefectural Cardiovascular Center
Division name
Division of Rehabilitation Medicine
Zip code
371-0004
Address
3-12 Kou, Kameizumi-cho, Maebashi, Gunma
TEL
0272697455
Homepage URL
inokuma-m@cvc.pref.gunma.jp
Sponsor or person
Institute
Other
Institute
Department
Personal name
Masami Inokuma
Funding Source
Organization
nothing
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Gunma Cardiovascular Center Ethics Review Committee
Address
3-12 Kou, Kameizumi-cho, Maebashi, Gunma
Tel
0272697455
inokuma-m@cvc.pref.gunma.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
| 2024 | Year | 08 | Month | 13 | Day |
Related information
URL releasing protocol
http://www.shinzouriha.jp/Archive/Pdf?goods_id=dq1careh/2023/002903/015/0264-0269
Publication of results
Published
Result
URL related to results and publications
http://www.shinzouriha.jp/Archive/Pdf?goods_id=dq1careh/2023/002903/015/0264-0269
Number of participants that the trial has enrolled
128
Results
After the intervention, the knee extension strength of the HT group increased significantly. AT and peak VO2 improved in both groups, and the rate of change was higher in the HT group than in the Con group. On the other hand, there was no improvement in skeletal muscle mass in both groups. A positive correlation was observed between knee extension muscle strength and peak VO2 change in both groups.
Results date posted
| 2024 | Year | 08 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patient Background
　The study included 128 cases, with 73 cases meeting the exclusion or contraindication criteria. After random allocation, 29 cases were assigned to the HT group, and 26 cases to the Con group. In the Con group, two cases of heart failure requiring hospitalization, one case requiring hospitalization for angina treatment, and one case of CRP self-discontinuation during outpatient care were excluded from the study. Finally, 24 cases in the HT group and 22 cases in the Con group were analyzed.
The average age was 69.7 years, and 52% were male. Chronic heart failure, angina pectoris, and myocardial infarction accounted for 93% of the cases.
Participant flow
The study included all new heart disease patients who visited our outpatient CRP (Cardiac Rehabilitation Program). After an initial observation period of two weeks following their first outpatient visit, we confirmed that patients could attend the CRP at least twice a week. Following this confirmation, we obtained informed consent and then randomly assigned the patients to either the HT group or the control group. The patients then underwent 150 days of exercise therapy. Physical function tests and cardiopulmonary exercise tests were conducted before and after the intervention.
The exclusion criteria were based on contraindications for exercise therapy as outlined in the guidelines. Additionally, patients who could not maintain a CRP attendance frequency of at least twice a week, those with implanted pacemakers or defibrillators, patients undergoing cardiac resynchronization therapy, and those with severe orthopedic or neurological conditions that made independent transfer to or use of a cycle ergometer difficult were also excluded from the study.
Adverse events
1 case of skin trouble at the electrode sheet attachment area was admitted and the equipment setting was changed.
Outcome measures
The primary outcome measure was the change in knee extension muscle strength (relative value) between the HT group and the Con group. Secondary outcome measures included the changes (relative values) in anaerobic threshold (AT), peak oxygen uptake (peak VO2), and skeletal muscle mass before and after the intervention. Physical functions, such as knee extension muscle strength and skeletal muscle mass, were measured.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2018 | Year | 09 | Month | 10 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 12 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 05 | Day |
Last follow-up date
| 2020 | Year | 07 | Month | 14 | 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 | 08 | Month | 09 | Day |
Last modified on
| 2024 | Year | 08 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039983
