Pulmonary hypertension
Conditions
Interventions
Participants undertake 8 weeks of lower limb training with neuromuscular electrical stimulation at home.
Sponsors
Chiba University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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)
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Variation in Quadriceps Thickness | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactShizu Miyata
Chiba University Hospital Department of Respirology
Outcome results
None listed