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NCT Number: NCT06670443

Electrical Stimulation for Respiratory and Leg Muscles Impact on COPD Patients

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

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Key information

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Physical Therapy

Dokki, Egypt

Location status: Recruiting

Location contact

ebtesam nagy, phd

CONTACT

marwa mahoud, phd

CONTACT

[email protected]

01156033818 ext. 02

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Other names: NMES

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).

Other names: placebo NMES

Primary outcomes

  1. dynamic gait index

    Time frame: 10 weeks

    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

Secondary outcomes

  1. pulmonary functions

    Time frame: 10 weeks

    It will be measured by spirometry to assess forced expiratory volume in the first second (FEV1), forced vital capacity (FVC), and FEV1/FVC. The patient is instructed to take in a deep breath and then, as fast as he can, blow out all the air into a tube connected to a machine (spirometer). To get the "best" test result, the test is repeated three times.

  2. Dyspnea

    Time frame: 10 weeks

    It will be assessed by modified Borg dyspnea scale which uses a scale from 0 to 10, where 0 represents no dyspnea and 10 represents maximal dyspnea

  3. International restless leg syndrome questionnaire

    Time frame: 10 weeks

    Developed as a tool for assessing the severity Restless Legs Syndrome (RLS), the 10-item questionnaire asks respondents to use Likert-type ratings to indicate how acutely the disorder has affected them over the course of the past week. Questions can be divided into one of two categories: disorder symptoms (nature, intensity, and frequency) and their impact (sleep issues, disturbances in daily functioning, and resultant changes in mood) Rating scale and the RLS will be evaluated using the lower-limit clinical definition issued by the IRLSSG. Respondents with four "yes" were treated as having RLS. Respondents further performed the IRSSG Severity Scale with ten items to determine the severity of RLS symptoms. Patients were categorized into four classes of RLS ratings: mild (0~10), moderate (11~20), extreme (21~30), and very serious (31~40)

  4. visual analogue scale

    Time frame: 10 weeks

    the pain will be evaluated by visual analogue scale (VAS) which assess pain intensity and progression. It is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured (symptom, pain, health) orientated from the left (worst) to the right (best).

  5. Sleep quality

    Time frame: 10 weeks

    It will be examined by pittsburgh sleep quality index (PSQI) which is a self-report questionnaire that assesses sleep quality over a 1-month time interval. It consisted of 19 items, the PSQI measures several different aspects of sleep, offering seven component scores and one composite score. The component scores consist of subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction.

    Each item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality

  6. Chronic Respiratory Disease Questionnaire

    Time frame: 10 weeks

    Qol will be evaluated by The Chronic Respiratory Disease Questionnaire (CRQ) is a disease-specific health-related quality of life questionnaire. It was developed to measure the impact of Chronic Obstructive Pulmonary Disease (COPD) on a person's life. It consists of 20 items across four dimensions: dyspnea, fatigue, emotional function, and mastery. Items in each section are scored from 1 (most severe) to 7 (no impairment).

Study contacts

Contact information is provided by the study sponsor or research team.

marwa mahmoud, phd

CONTACT

[email protected]

01156033818 ext. 02

mushabab alahmari, phd

CONTACT

[email protected]

563920029 ext. 00966

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Nov 1, 2024
Registry last updated
Sep 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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