Using electrical stimulation to improve exercise capacity in critically ill respiratory patients
Effects of Neuromuscular Electrical Stimulation on Exercise Capacity in Respiratory Critically Ill Patients
This study is testing if using electrical stimulation along with regular physiotherapy can help critically ill patients with respiratory issues exercise better while they are in the ICU.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospital Clinic of Barcelona Academic / other |
| Locations | 1 site (Barcelona) |
| Trial ID | NCT03083652 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effects of neuromuscular electrical stimulation (NMES) combined with conventional physiotherapy on exercise capacity in critically ill patients with respiratory diseases. The study involves a randomized, controlled, double-blind design where participants will receive either NMES or a sham treatment during their stay in the intensive care unit (ICU). The primary focus is on patients who are on mechanical ventilation for more than 72 hours, assessing their muscle strength and functional capacity. Measurements will include demographic data, body composition, and functional capacity before admission.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old diagnosed with acute or acute on chronic respiratory diseases requiring mechanical ventilation for more than 72 hours.
Not a fit: Patients with pre-existing neuromuscular diseases or those experiencing severe respiratory or hemodynamic instability may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance recovery and muscle function in critically ill patients, potentially reducing long-term disability.
How similar studies have performed: Previous studies have shown promising results with neuromuscular electrical stimulation in similar patient populations, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis at admission: acute or acute on chronic respiratory disease * Mechanical ventilation \> 72h at inclusion * Expected mechanical ventilation \> 24h * Informed consent Exclusion Criteria: * Patients re-admitted to ICU (no hospital discharge) * Exitus or transfer to another service/hospital * Respiratory instability \[Inspired fraction of oxygen (FIO2) \>60% or positive end-expiratory pressure (PEEP) \>10 cmH2O\] and/or hemodynamic instability \[Mean arterial pressure ( MAP)\<60mmHg although vasoactive drugs\] during \> 24h. * Pregnancy * Neuromuscular disease before admission * Skin lesions * Limitation of therapeutic effort * Mental and/or physical limitation to understand/realize tests for evaluation
Where this trial is running
Barcelona
- Unidad de Vigilancia Intensiva Respiratoria (UVIR) — Barcelona, Spain (Recruiting)
Study contacts
- Principal investigator: Joan-Daniel Martí, Pt,PhD — Physiotherapist
- Study coordinator: Joan-Daniel Martí, PT,PhD
- Email: jd.martibcn@gmail.com
- Phone: 0034932275400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.