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NCT04684966: COMBIELEC
Combined Neuromuscular Electrical Stimulation for Quadriceps and Triceps During Pulmonary Rehabilitation in COPD
NA trial testing Neuromuscular Electrical Stimulation in Chronic Obstructive Pulmonary Disease Overlap Syndrome in 266 participants. Completed in 23 December 2024.
23 December 2024
Quick facts
| Lead sponsor | University Hospital, Brest |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | health services research |
| Enrollment | 266 |
| Start date | 8 April 2021 |
| Primary completion | 23 December 2024 |
| Estimated completion | 23 December 2024 |
| Sites | 1 location across France |
Drugs / interventions tested
- Neuromuscular Electrical Stimulation
- Sham Neuromuscular Electrical Stimulation
Conditions studied
- Chronic Obstructive Pulmonary Disease Overlap Syndrome — all drugs for Chronic Obstructive Pulmonary Disease Overlap Syndrome →
- Asthma — all drugs for Asthma →
Sponsor
University Hospital, Brest
Who can join
18 and older, any sex, with Chronic Obstructive Pulmonary Disease Overlap Syndrome or Asthma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Patients with COPD frequently have muscle disorders. Pathogenic mechanisms generate significant pathophysiological changes in the locomotor muscles structure, leading to decreased strength, decreased endurance and limited exercise capacity. Pulmonary rehabilitation is the first choice therapy and training overall lower limb endurance is a priority. Even if the effects of pulmonary rehabilitation are no longer to be demonstrated, it is still necessary to optimize the modalities of muscular strengthening. In fact, it is recommended to associate to this global endurance training a specific strengthening of the muscles of the lower limbs. Neuromuscular electrostimulation (NMES) is a muscular strengthening technique, but this method is not used in usual practice in pulmonary rehabilitation and often only the quadriceps are concerned. In a pulmonary rehabilitation program, including sessions of NMES of the quadriceps femoris and triceps surae could increase its effectiveness. Recent studies suggest that NMES can improve muscle function, exercise tolerance, dyspnea and quality of life in COPD patients. A pilot study compared the effects of the combined quadriceps femoris and triceps surae versus quadriceps alone. The final evaluation showed a greater improvement in exercise capacity in favour of the combined NMES group. Only two studies with small numbers of patients evaluated the effect of combined quadriceps femoris and triceps surae NMES in pulmonary rehabilitation, with encouraging results in terms of functional gain. Further larger studies seem necessary to evaluate the effects of combined quadriceps femoris and triceps surae NMES in pulmonary rehabilitation. The objective of the study is to show that combined quadriceps femoris and triceps surae NMES during a pulmonary rehabilitation program provides a more significant improvement in exercise capacity compared to a standard pulmonary rehabilitation program.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04684966
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Trials testing the same drug.
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- NCT06872697 — Impact of Whole Body Vibration on Muscle Function and Respiratory Parameters in Intensive Care Patients · NA · completed
- NCT06887855 — Enhancing Post-Stroke Dysphagia Rehabilitation · NA · recruiting
Other University Hospital, Brest trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04684966 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Hospital, Brest
- Last refreshed: 5 February 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04684966.
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