Stress free therapy for COPD

JRCT ID: jRCT1032210546

Registered date:13/01/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: COPD
• Date of first enrollment: 01/10/2021
• Target sample size: 20
• Study type: Observational

Outcome(s)

Primary Outcome

Primary endpoint:
Evaluation items before and after the intervention; evaluation of dyspnea by COPD assessment test (CAT), visual analogue scale (VAS), modified British Medical Research Council (mMRC)

Secondary Outcome

Secondary endpoint and 3) Safety endpoint
Changes in the following endpoints: patient background and attribute data (including personal information); age, gender, number of hospitalizations, COPD diagnosis date, GOLD classification, aggravation risk factors (comorbidities, BMI, smoking history, solids) Organ transplantation, presence / absence of immunodeficiency (including HIV infection), pregnancy, etc., medication status (medication for COPD, medication for other diseases), history, allergy history, moderate progression date, severe progression date, symptom improvement date , Intervention start date, number of interventions, intervention end date (8 weeks later)

Key inclusion & exclusion criteria

• Age minimum: >= 40age old
• Age maximum: <= 80age old
• Gender: Both

Include criteria

Research subjects (those who meet all of the following items)
Have been diagnosed with COPD and are outpatient
(2) COPD is a patient who falls under stage II or stage III in the GOLD classification.
Patients with a CAT score of 10 points or higher and an mMRC of grade 1 or higher
Patients whose general condition is stable
Patients whose age at the time of obtaining consent is 40 to 80 years old

Exclude criteria

Exclusion criteria
Patients with a history of affecting the evaluation items (neurological disorders, osteoarthritis, etc.)
Contraindications for physical therapy
Users of implantable electronic devices (pacemakers, etc.), patients with heart disease, malignant tumor, tuberculous disease, or acute disease, those who are extremely debilitated, pregnant women or those who may become pregnant, perception / skin by atopy, etc. Persons with hypersensitivity, possible impaired blood flow, using metal implants, history of or suspected of having epilepsy.
Others who are deemed inappropriate by the doctor.
In the following cases, it is at the discretion of the doctor. Abnormal blood pressure, fever, or infectious disease, etc.
Patients who cannot attach electrodes due to skin diseases, etc.
Patients who changed or added the main drug therapy of COPD during the study period from the time of obtaining consent
Those who the doctor in charge judges to be inappropriate for participation in the research
Those who receive stress-free therapy on a daily basis

Related Information

• Primary Sponsor: Tetsuya Homma