UMIN ID: UMIN000021024
Registered date:15/02/2016
Will simple home Waon (thermal) therapy improve circulatory status and oxidative stress long term after Fontan operation? -First Waon (thermal) therapy trial in patients after Fontan operation
Basic Information
| Recruitment status | Complete: follow-up continuing |
|---|---|
| Health condition(s) or Problem(s) studied | Patients long term after Fontan operation |
| Date of first enrollment | 2016/02/15 |
| Target sample size | 40 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Waon therapy using far infrared dome sauna five times a week over one year |
Outcome(s)
| Primary Outcome | Noninvasively obtained hemodynamic and cardiovascular function, heart rate variability, exercise tolerance, daily work, oxidative stress, neurohormone at 6 months after Waon therapy |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | 6years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | severe heart failre no consent to participate the study patients who are not suitable for Waon theraphy, judged by attending physician |
Related Information
| Primary Sponsor | Saitama Medical Center Saitama Medical University |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Miyata cardiac research promotion foundation |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Satoshi Masutani |
| Address | 1981 Kamoda, Kawagoe-shi, SAITAMA 350-8550, JAPAN Japan 350-8550 |
| Telephone | 049-228-3400 |
| smstn@ka2.so-net.ne.jp | |
| Affiliation | Saitama Medical Center Saitama Medical University Pediatric Cardiology |
| scientific contact | |
| Name | Satoshi Masutani |
| Address | 1981 Kamoda, Kawagoe-shi, SAITAMA 350-8550, JAPAN Japan |
| Telephone | 049-228-3550 |
| smstn@ka2.so-net.ne.jp | |
| Affiliation | Saitama Medical Center Saitama Medical University Pediatric Cardiology |