Does Neuromuscular Electrical Stimulation Benefit the Functional Ability of Elderly Patients With Chronic Obstructive Lung Disease

Pulmonary Rehabilitation Clinical Trial

— NEMS for COPD  

Official title:

Does Neuromuscular Electrical Stimulation Benefit the Functional Ability of Elderly Patients With Chronic Obstructive Lung Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05838911
• Other study ID #: BeniSuefU_1
• Status: Completed
• Phase: N/A
• Start date: April 2, 2023
• Est. completion date: August 13, 2023

Study information

• Verified date: April 2024
• Source: Beni-Suef University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Background: Patients with COPD often experience skeletal muscle dysfunction. For those who are unable or unwilling to undertake physical training, neuromuscular electrical stimulation (NMES) may provide an alternative method of exercise training.

Objective: To investigate the effects of adding neuromuscular electrical stimulation of gluteus maximus, quadriceps and calf muscles to chest physiotherapy, compared to chest physiotherapy alone, on muscles strength (gluteus max., quadriceps, calf muscles), femoral blood flow physical and pulmonary function in severe COPD Patients.

Description:

Material and methods: This study include a group of 60 patients (30 males and 30 females) diagnosed with severe COPD), their age is ranged 65-75 years, they will be randomly divided into two groups; study group (A) 30 patients and study group (B) 30 patients. Study group (A): The patients in this group will receive the chest physiotherapy program for 20 min each day, for five days a week for three consecutive weeks. Study group (B): The patients in this group will receive the same chest physiotherapy program combined with neuromuscular electrical stimulation of gluteus max., quadriceps, calf muscles, performed for 30 min /day for five days a week for three consecutive weeks. Femoral blood Flow, gluteus maximus, quadriceps and calf muscles strength and pulmonary function (FEV1/FVC) will be measured for both groups pre and post treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 13, 2023
• Est. primary completion date: August 13, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 75 Years

Eligibility

Inclusion Criteria:

• A diagnosis of COPD with FEV1/FVC <50% predicted as per the GOLD guidelines.

• Self-reported dyspnea and/or arm fatigue during at least one activity of daily living that required arm exercise.

• Dyspnea and/or physical activity fatigue were self-reported by the Borg Scale.

• Before entering in the study, all patients had their pulmonary function optimized with long-acting bronchodilators and corticosteroids.

Exclusion Criteria:

• • Patients with unstable angina pectoris.

• Progressive ventricular dysrhythmia.

• Intermittent claudication.

• Implanted cardiac pacemakers.

• Uncontrolled diabetes mellitus.

• Peripheral vascular disease.

Related Conditions & MeSH terms

• Chronic Obstructive Lung Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Neuromuscular Electrical Stimulation
• Pulmonary Disease, Chronic Obstructive
• Pulmonary Rehabilitation

Intervention

Other:
• Study Group chest physiotherapy program combined with neuromuscular electrical stimulation (NMES)
The patients in this group were received the same chest physiotherapy program combined with neuromuscular electrical stimulation of gluteus max., quadriceps, and calf muscles performed for 30 min /day for five days a week for three consecutive weeks.
• Control Group Chest physical therapy
The patients in this group were received the chest physiotherapy program for 20 min each day, for five days a week for three consecutive weeks

Locations

Country	Name	City	State
Egypt	Department of P.T for internal medicine, Faculty of Physical Therapy, South valley university, Qena, Egypt	Qina

Sponsors (2)

Lead Sponsor	Collaborator
Beni-Suef University	South Valley University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Six-minute walking test (Physical function assessment	The six-minute walking distance (6MWD) was measured according to a standardized protocol.; Subjects were instructed to walk at their own pace along a 34.5-m corridor from one end to the other, covering as much ground as possible in the allotted time.; Subjects were allowed to stop and rest during the test, but they were instructed to resume walking as soon as they felt able to do	change from baseline to 3 weeks after intervention and 3 days as a follow-up
Primary	Pulmonary function test	Pulmonary capacity and respiratory muscle functions will be assessed using the CPFS/D USB™ 187 Spirometer (Medical Graphics-MGC, St. Paul, MN, USA) with airflow being measured by a 188 calibrated Pitot tube (PreVent, Pneumotach). The participant completed at least three acceptable maximal forced and slow expiratory maneuvers after 15 min the inhalation of 400 mg of salbutamol 190 via a metered-dose inhaler. Forced vital capacity (FVC, L), forced expiratory volume in one second (FEV1, L), FEV1/ FVC, and inspiratory capacity (IC) will be measured according to American Thoracic Society standards	change from baseline to 3 weeks after intervention and 3 days as a follow-up
Primary	Muscle strength measurement	To determine the maximal muscle strength the Lafayette manual muscle test system (USER MANUAL) (MMT) Model 01163, White Plains, New York (10602) of gluteus maximus, quadriceps and calf muscles will be measured on right lower limb.	change from baseline to 3 weeks after intervention and 3 days as a follow-up
Secondary	Blood flow velocimetry measurement	To evaluate changes in peripheral perfusion. The standard pulsed-wave Doppler velocimetry of the right femoral artery was performed using sonos 2000 echograph (Philips Envisor )	change from baseline to 3 weeks after intervention and 3 days as a follow-up