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Recruiting NCT06670443

Electrical Stimulation for Respiratory and Leg Muscles Impact on COPD Patients

No phase Interventional Chronic Obstructive Pulmonary Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: experimental group, control group.
Who it may be relevant to
Registry conditions: Chronic Obstructive Pulmonary Disease. Basic parameters: 40 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Electrical Stimulation for Respiratory and Leg Muscles Impact on Pulmonary Function and Leg Restless Syndrome in COPD Patients

Overview

Electrical neuromuscular stimulation electrode patches will be applied over the intercostal respiratory muscles and leg muscles In addition to conventional pulmonary rehabilitation

Detailed description

Intervention group: active NMES (350 μs pulses - 50 Hz frequency) will be applied at the lower third of the thigh, just above the patella, and the proximal electrode 5-10 cm below the anterior superior iliac spine for quadriceps muscle stimulation, and for intercostal muscles stimulation, NMES will be bilaterally, parallel to the ribs, in the intercostal space. The proximal electrode will be positioned close to the sternum, and the distal electrode laterally, close to the midaxillary line. In addition to conventional pulmonary rehabilitation program that comprised diaphragmatic and pursed lips breathing.

control group: placebo NMES at the same points in addition to the same conventional pulmonary rehabilitation program

Interventions

  • Device experimental group
    Electrical neuromuscular stimulation electrode patches will be applied over the intercostal respiratory muscles and leg muscles (placed superficially just below each knee, over the head of the fibula, in close proximity to the common peroneal nerve).
  • Device control group
    Placebo electrical neuromuscular stimulation electrode patches will be applied over the intercostal respiratory muscles and leg muscles (placed superficially just below each knee, over the head of the fibula, in close proximity to the common peroneal nerve).

Primary outcome measures

  • dynamic gait index [Time frame: 10 weeks]
Secondary outcome measures (6)
  • pulmonary functions [Time frame: 10 weeks]
  • Dyspnea [Time frame: 10 weeks]
  • International restless leg syndrome questionnaire [Time frame: 10 weeks]
  • visual analogue scale [Time frame: 10 weeks]
  • Sleep quality [Time frame: 10 weeks]
  • Chronic Respiratory Disease Questionnaire [Time frame: 10 weeks]

Eligibility criteria

Inclusion criteria

  • Patient undergoes four main clinical criteria for the diagnosis of RLS according to the international restless leg syndrome study group (IRLSSG) including
  • an urge to move legs that is usually associated with paresthesia.
  • alleviation of the symptoms by moving the legs.
  • aggravation or exacerbation of the symptoms particularly at rest or during sitting or lying down in the bed.
  • worsening of the signs at night. patients with diagnosed with grade I and grade II COPD their ages ranged between 45-55 o All patients will be clinically and medically stable when attending the study

Exclusion criteria

  • History of Deep venous thrombosis
  • History of Bleeding disorders
  • Have an implantable device like a pacemaker
  • Recent Infected wound
  • History of allergic response to the electrodes, gel or tape
  • patients who participating in any other exercise program
  • Loss of sensation or numbness

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Faculty of Physical Therapy — Dokki

Identifiers

NCT: NCT06670443 · P.T.REC/012/005638

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗