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Effects of bedside rehabilitation training combined with electrical stimulation on respiratory function in ICU patients

Effects of bedside lower-limb active-passive rehabilitation training combined with external diaphragmatic phrenic nerve electrical stimulation on respiratory function in ICU patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600129145
Enrollment
Unknown
Registered
2026-07-31
Start date
2026-08-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Care Rehabilitation

Interventions

Control group:The control group received routine rehabilitation therapy, including active and passive exercises of the limbs and active and passive stretching. All activities were performed with progr
Intervention group:The control group received conventional manual rehabilitation therapy administered by a rehabilitation therapist, which consisted of active and passive limb exercises and stretching
Shanghai Medical Device Registration No.: 20252190402) was used in the active?passive assisted mode, with the range of motion individually adjusted according to each participant's condition. The train

Sponsors

The First Affiliated Hospital of Naval Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. age >= 18 years; 2. received invasive mechanical ventilation for >=48 h or non-invasive mechanical ventilation for >=48 h; 3. APACHE II score >= 15; 4. ICU Mobility Scale score <= 1; 5. written informed consent was obtained from their legal representative or next of kin.

Exclusion criteria

Exclusion criteria: 1. lack of informed consent; 2. pre-existing diaphragmatic paralysis or phrenic nerve injury; 3. severe upper gastrointestinal bleeding; 4. unhealed bone fractures, severe osteoporosis, or deep vein thrombosis; 5. uncontrolled epilepsy; 6. restricted passive range of motion of the lower limb joints or excessively high muscle tone in the lower extremities; 7. severe cardiac arrhythmias, permanent pacemaker implantation, or implantable cardioverter-defibrillator; 8. uncontrolled hypertension (systolic blood pressure >200 mmHg or diastolic blood pressure >110 mmHg), poorly controlled diabetes, or significant dysfunction of major organs including the liver, kidneys, and heart; 9. history of severe asthma; 10. unstable vital signs; 11. tumor located at the electrode attachment sites (bilateral mid-clavicular lines, second intercostal space); 12. current participation in another clinical trial; 13. respiratory failure due to underlying conditions such as acute cardiogenic pulmonary edema, severe traumatic brain injury or stroke, high cervical spinal cord injury (above C5), or other neuromuscular disorders.

Design outcomes

Primary

MeasureTime frame
Diaphragmatic Thickening Fraction;

Secondary

MeasureTime frame
Diaphragmatic excursion ;Lower limb muscle thickness;

Countries

China

Contacts

Public ContactFang fanfu; Lv can

The First Affiliated Hospital of Naval Medical University

fangfanfu@126.com+86 158 0071 9913

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 10, 2026