JRCT ID: jRCT1030260008
Registered date:02/04/2026
Development and evaluation of the Silvester method Self-Management Program(SSMP) to make breathing easier for patients with chronic obstructive pulmonary disease
Basic Information
| Recruitment status | Not Recruiting |
|---|---|
| Health condition(s) or Problem(s) studied | Chronic Obstructive Pulmonary Disease |
| Date of first enrollment | 02/04/2026 |
| Target sample size | 35 |
| Countries of recruitment | |
| Study type | Interventional |
| Intervention(s) | Silvester's method: 1 set per day (12 repetitions, 2 minutes), multiple times per day if comfortable, for 2 months. |
Outcome(s)
| Primary Outcome | Patient-Reported Outcomes using the Dyspnoea-12 Japanese version in patients with breathlessness. |
|---|---|
| Secondary Outcome | 1. HRQoL was assessed using the SGRQ Japanese version 2 Patient-Reported Outcomes. 2. Body activity level, measured using an Omron HJ-325 pedometer (Omron) and recorded in the diary. 3. The proportion of patients who continued the Silvester method, calculated from the content of the therape utic diary. |
Key inclusion & exclusion criteria
| Age minimum | >= 65age old |
|---|---|
| Age maximum | Not applicable |
| Gender | Male |
| Include criteria | 1. Home-based care for stable COPD patients undergoing outpatient treatment. 2. 65-year-old male patients. 3. Patients who have given their written consent to participate in the study. 4. Patients who understand the survey content, can implement the Silvester method, complete the self-ad mini stered questionnaire, and are not planning to move or change hospitals within two months. , and who can participate in the two-month study without interruption. 5. Patients who can understand and write in Japanese. |
| Exclude criteria | 1. Patients undergoing ventilation support therapy and surgery. 2. Patients with emphysema-associated interstitial pneumonia. 3. Patients with heart failure that affects their breathing. 4. Patients with a history of shoulder joint disease, or those who experience pain when moving. 5.Patients for whom it is impossible to measure the number of steps taken using a pedometer. 6. Patients diagnosed with depression and experiencing emotional instability. 7. Other patients deemed unsuitable by the attending physician. |
Related Information
| Primary Sponsor | Taniguchi Tamami |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | University of Yamanashi |
| Secondary ID(s) |
Contact
| Public contact | |
| Name | Sachiko Nishiyama |
| Address | 1110, Shimokato, Chuo-city, Yamanashi Yamanashi Japan 409-3898 |
| Telephone | +81-55-273-1111 |
| g23ddn02@yamanashi.ac.jp | |
| Affiliation | University of Yamanashi |
| Scientific contact | |
| Name | Tamami Taniguchi |
| Address | 1110, Shimokato, Chuo-city, Yamanashi Yamanashi Japan 409-3898 |
| Telephone | +81-55-273-1111 |
| tamamit@yamanashi.ac.jp | |
| Affiliation | University of Yamanashi |