UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055224 |
|---|---|
| Receipt number | R000062993 |
| Scientific Title | Investigation of the Efficacy and Safety of Rehabilitation with Neuromuscular Electrical Stimulation in Patients with Pulmonary Hypertension |
| Date of disclosure of the study information | 2024/09/01 |
| Last modified on | 2025/08/26 10:42:07 |
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Basic information
Public title
Investigation of the Efficacy and Safety of Rehabilitation with Neuromuscular Electrical Stimulation in Patients with Pulmonary Hypertension
Acronym
Investigation of the Efficacy and Safety of Rehabilitation with Neuromuscular Electrical Stimulation in Patients with Pulmonary Hypertension
Scientific Title
Investigation of the Efficacy and Safety of Rehabilitation with Neuromuscular Electrical Stimulation in Patients with Pulmonary Hypertension
Scientific Title:Acronym
Investigation of the Efficacy and Safety of Rehabilitation with Neuromuscular Electrical Stimulation in Patients with Pulmonary Hypertension
Region
| Japan |
Condition
Condition
Pulmonary hypertension
Classification by specialty
| Cardiology | Pneumology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we will explore whether self-training with NMES in patients with pulmonary hypertension provides medical benefits, such as improved exercise tolerance and health-related quality of life.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Variation in Quadriceps Thickness
Key secondary outcomes
Secondary efficacy endpoints: change in emPHasis-10, change in walking distance in the 6-minute walk test, change in BNP, change in tricuspid valve pressure gradient, change in right atrial area, change in left ventricular ejection fraction, change in inferior vena cava diameter, change in thigh extensor muscle strength, change in weight, change in Short Physical Performance Battery
Secondary safety and tolerability endpoints: incidence and details of adverse events
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 |
Interventions/Control_1
Participants undertake 8 weeks of lower limb training with neuromuscular electrical stimulation at home.
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
A person who fulfils all of the following
1) Aged 18 years or over at the time of obtaining consent.
2) Have been diagnosed with pulmonary hypertension and have not been hospitalised for worsening of the disease within 3 months prior to obtaining consent.
3) WHO functional class I-III
4) Patients who have given a full explanation of their participation in the study, and who have given their free and voluntary written consent based on a full understanding of the study.
Translated with DeepL.com (free version)
Key exclusion criteria
Persons who fall into one of the following categories
1) Persons with osteoarticular or neuromuscular diseases affecting walking
2) Persons with inadequately controlled cardiac insufficiency, cardiac disease or arrhythmia
3) Persons with mental illness or cognitive impairment that prevents them from performing the examination and neuromuscular electrical stimulation safely and accurately
4) Persons who use precision equipment (e.g. pacemakers, portable infusion pumps) that cannot be denied to malfunction due to neuromuscular electrical stimulation.
5) Persons with skin diseases at the site of electrode application.
6) Persons with venous thrombosis in the lower limbs
7) Persons with metal implants such as bolts in the lower limbs.
8) Persons who fulfil one of the following criteria at the time of registration.
8-1. resting pulse less than 40/min or more than 120/min
8-2. resting systolic blood pressure of 70 mmHg or less or 200 mmHg or more
8-3. diastolic blood pressure at rest 120 mmHg or higher
8-4. palpitations, shortness of breath, chest pain, dizziness or cold sweat at rest
9) Any change in treatment for the primary disease or unscheduled hospitalisation after enrolment and before the end of the observation period.
10) Other persons who are deemed unsuitable by the principal investigator or a research assistant.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Takuji |
| Middle name | |
| Last name | Suzuki |
Organization
Chiba University Hospital
Division name
Department of Respirology
Zip code
2608677
Address
1-8-1 Inohana, Chuo-Ku, Chiba
TEL
0432227171
suzutaku@chiba-u.jp
Public contact
Name of contact person
| 1st name | Shizu |
| Middle name | |
| Last name | Miyata |
Organization
Chiba University Hospital
Division name
Department of Respirology
Zip code
2608677
Address
1-8-1 Inohana, Chuo-Ku, Chiba
TEL
0432227171
Homepage URL
smiyata@chiba-u.jp
Sponsor or person
Institute
Chiba University Hospital
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
The Observational Research Ethics Committee of Chiba University Hospital
Address
1-8-1 Inohana, Chuo-Ku, Chiba
Tel
0432227171
hsp-kansaturinri@chiba-u.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 | 09 | Month | 01 | 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 | 07 | Month | 02 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 02 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | 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 | 08 | Month | 12 | Day |
Last modified on
| 2025 | Year | 08 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062993
