UMIN ID: UMIN000056149
Registered date:13/11/2024
A study on optimal exercise dose for electrical stimulation therapy in critically ill intensive care unit patients.
Basic Information
| Recruitment status | Pending |
|---|---|
| Health condition(s) or Problem(s) studied | Patients aged 18 years and over expected to stay in ICU for more than 3 days |
| Date of first enrollment | 2024/12/01 |
| Target sample size | 80 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Treatment (B-SES 60 min/day) starts on the day of registration (Day 1) and is administered daily from Day 1 to Day 7.It should be done for a total of 60 minutes, with interruptions along the way. Treatment (B-SES 20 min/day) starts on the day of registration (Day 1) and is administered daily from Day 1 to Day 7.It should be done for a total of 20 minutes, with interruptions along the way. |
Outcome(s)
| Primary Outcome | Percentage change in rectus femoris muscle cross-sectional area (assessed using ultrasound echocardiography on days 1 and 7 of B-SES implementation) |
|---|---|
| Secondary Outcome | -Muscle injury (assessed using N-TITIN/urinary Cre on days 3/5/7 of B-SES start) -Adverse events during B-SES implementation -Physical function at discharge (grip strength, Medical Research Council Score, 6-minute walk distance) -ADL(Barthel Index) at discharge |
Key inclusion & exclusion criteria
| Age minimum | 18years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | (1) Patients with unstable circulatory and respiratory status (2) Patients with external cardiopulmonary ventilation (3) Patients with trauma, infection, surgery, ischaemia or thrombosis of the lower limbs (4) Patients with anuria (5) Patients with implanted electronic devices (e.g. pacemakers) (6) Patients who do not wish to undergo aggressive treatment (7) Pregnant women (8) Patients with neuromuscular diseases (9) Patients on muscle relaxants (10) Patients considered unsuitable. |
Related Information
| Primary Sponsor | Yokohama City University Hospital |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Ministry of Education, Culture, Sports, Science and Technology |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Hideyuki Oritsu |
| Address | 3-9, Fukura, Yokohama Shi Kanazawa Ku, Kanagawa Ken, Japan Japan 2360004 |
| Telephone | 0457872800 |
| oritsu@yokohama-cu.ac.jp | |
| Affiliation | Yokohama City University Hospital Rehabilitation Department |
| scientific contact | |
| Name | Masafumi Idei |
| Address | 3-9, Fukura, Yokohama Shi Kanazawa Ku, Kanagawa Ken, Japan Japan |
| Telephone | 0457872800 |
| idei.mas.bn@yokohama-cu.ac.jp | |
| Affiliation | Yokohama City University Hospital Intensive Care Department |