UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057270 |
|---|---|
| Receipt number | R000065462 |
| Scientific Title | Whole-body electromyostimulation in patients with chronic respiratory disease: a pilot single-arm safety and feasibility study |
| Date of disclosure of the study information | 2025/03/12 |
| Last modified on | 2026/03/13 09:18:25 |
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Basic information
Public title
Whole-body electromyostimulation in patients with chronic respiratory disease: a pilot single-arm safety and feasibility study
Acronym
Whole-body electromyostimulation in patients with chronic respiratory disease: a pilot single-arm safety and feasibility study
Scientific Title
Whole-body electromyostimulation in patients with chronic respiratory disease: a pilot single-arm safety and feasibility study
Scientific Title:Acronym
Whole-body electromyostimulation in patients with chronic respiratory disease: a pilot single-arm safety and feasibility study
Region
| Japan |
Condition
Condition
Chronic respiratory disease
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to investigate the safety and feasibility of whole-body electromyostimulation in pulmonary rehabilitation in patients with chronic respiratory disease.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Amount of change in repetitions of 1-minute sit-to-stand test and 6-minute walking distance
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Other |
Interventions/Control_1
Participants wear an EMS suit and perform resistance exercise training.
Interventions/Control_2
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients will be deemed eligible for the study if they are at least 18 years old, have a confirmed diagnosis of CRD, clinically stable, and have no pulmonary rehabilitation session for the past six months.
Key exclusion criteria
People with CRD will be excluded if they (i) have a marked exercise-induced desaturation; (ii) have a difficulty with exercise due to complications or disability; (iii) have cardiac disease that is at risk with exercise; (iv) violates precautions for EMS suit use (neuromuscular problems, skin problems such as hypersensitivity or sensory disturbance, using a pacemaker or other medical electrical device, having a tumor, etc.); (v) have visual or hearing problems; (vi) have any other problems that have stopped them from exercising with their doctors; (vii) are unable to understand the exercise sufficiently; (viii) have a diagnosis of cognitive dysfunction.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Atsuhito |
| Middle name | |
| Last name | Nakazawa |
Organization
Kanagawa Cardiovascular and Respiratory Center
Division name
Department of Respiratory Medicine
Zip code
236-0051
Address
6-16-1, Tomioka-higashi, Kanazawa-ku Yokohama
TEL
045-701-9581
gda_kawasaki@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Atsuhito |
| Middle name | |
| Last name | Nakazawa |
Organization
Kanagawa Cardiovascular and Respiratory Center
Division name
Department of Respiratory Medicine
Zip code
236-0051
Address
6-16-1, Tomioka-higashi, Kanazawa-ku Yokohama
TEL
045-701-9581
Homepage URL
gda_kawasaki@yahoo.co.jp
Sponsor or person
Institute
Kanagawa Cardiovascular and Respiratory Center
Institute
Department
Personal name
Funding Source
Organization
Kanagawa Cardiovascular and Respiratory Center
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board, Kanagawa Cardiovascular and Respiratory Center
Address
6-16-1, Tomioka-higashi, Kanazawa-ku Yokohama
Tel
0457019581
onoda.3810g@kanagawa-pho.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
| 2025 | Year | 03 | Month | 12 | 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
| 2023 | Year | 10 | Month | 25 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 10 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 21 | Day |
Last follow-up date
| 2027 | Year | 08 | 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
| 2025 | Year | 03 | Month | 12 | Day |
Last modified on
| 2026 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065462
