Electrical Stimulation for Respiratory and Leg Muscles Impact on COPD Patients

Cairo University (CU)

Status: Enrolling

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Device: control group; Device: experimental group

Study type: Interventional

Funder types: Other

Identifiers

NCT06670443

P.T.REC/012/005638

Details and patient eligibility

About

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

Full 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

Enrollment: 60 estimated patients

Sex: All

Ages: 40 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient undergoes four main clinical criteria for the diagnosis of RLS according to the international restless leg syndrome study group (IRLSSG) including

  1. an urge to move legs that is usually associated with paresthesia.
  2. alleviation of the symptoms by moving the legs.
  3. aggravation or exacerbation of the symptoms particularly at rest or during sitting or lying down in the bed.
  4. 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

experimental group

Experimental group

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 bilateral, 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

Treatment:

Device: experimental group

control group

Placebo Comparator group

Description:

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

Treatment:

Device: control group