Electrical Stimulation for Respiratory and Leg Muscles Impact on COPD Patients

NCT06670443 | Recruiting

• 1 other identifier: P.T.REC/012/005638
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• dynamic gait index

  It will be measured by dynamic gait index which includes eight items, walking on level surfaces, changing speeds, head turns in horizontal and vertical directions, walking and turning 180 degrees to stop, stepping over and around obstacles, and stair ascent and descent. Each item is scored on a scale of 0 to 3, with 3 indicating normal performance and 0 representing severe impairment. The best possible score on the DGI is a 24

  10 weeks

Secondary Outcomes (6)

• pulmonary functions

  10 weeks

• Dyspnea

  10 weeks

• International restless leg syndrome questionnaire

  10 weeks

• visual analogue scale

  10 weeks

• Sleep quality

  10 weeks

Study Arms (2)

experimental group

EXPERIMENTAL

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

Device: experimental group

control group

PLACEBO COMPARATOR

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

Device: control group

Interventions

experimental group 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).

Also known as: NMES

experimental group

control group 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).

Also known as: placebo NMES

control group

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Physical Therapy

Dokki, Egypt

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

mushabab alahmari, phd

CONTACT

563920029; malahmarirrt@gail.com

marwa mahmoud, phd

CONTACT

01156033818; marwadd999@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 31, 2024
• First Posted: November 1, 2024
• Study Start: January 10, 2025
• Primary Completion: November 30, 2025
• Study Completion: December 30, 2025
• Last Updated: September 15, 2025

Record last verified: 2025-09

Locations

EG (1)