Electrical Stimulation for Respiratory and Leg Muscles Impact on COPD Patients

NCT ID: NCT06670443

Last Updated: 2025-09-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-10

Study Completion Date

2025-12-30

Brief Summary

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

Detailed Description

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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

Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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experimental group

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

Group Type EXPERIMENTAL

experimental group

Intervention Type DEVICE

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).

control group

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

Group Type PLACEBO_COMPARATOR

control group

Intervention Type DEVICE

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).

Interventions

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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).

Intervention Type 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).

Intervention Type DEVICE

Other Intervention Names

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NMES placebo NMES

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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marwa mahmoud elsayed mahmoud

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Physical Therapy

Dokki, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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mushabab alahmari, phd

Role: CONTACT

563920029 ext. 00966

marwa mahmoud, phd

Role: CONTACT

01156033818 ext. 02

Facility Contacts

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marwa mahoud, phd

Role: primary

01156033818 ext. 02

ebtesam nagy, phd

Role: backup

Other Identifiers

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P.T.REC/012/005638

Identifier Type: -

Identifier Source: org_study_id

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