Electrical Stimulation for Respiratory and Leg Muscles Impact on COPD Patients

Not Applicable

Recruiting

• Conditions: Chronic Obstructive Pulmonary Disease

• Registration Number: NCT06670443
• Lead Sponsor: Cairo University

Brief Summary

Electrical neuromuscular stimulation electrode patches will be applied over the intercostal respiratory muscles and leg muscles

Detailed Description

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).

Active stimulation consisted of a ∼30-second ramp-up to the titrated intensity value at the start of stimulation, ∼30 minutes at the titrated intensity, and a 10-second ramp-down at the end of stimulation.

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-31
• Study First Submitted QC: 2024-10-31
• Last Update Submitted: 2024-10-31
• Study First Posted: 2024-11-01
• Last Update Posted: 2024-11-01
• Study Start: 2024-11-10
• Primary Completion: 2025-08-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
dynamic gait index	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 Outcome Measures

Name	Time	Method
pulmonary functions	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.
Dyspnea	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
International restless leg syndrome questionnaire	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)
visual analogue scale	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).
Sleep quality	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
Chronic Respiratory Disease Questionnaire	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).

Trial Locations

Locations (1)

Faculty of Physical Therapy; 🇪🇬 Dokki, Egypt