Does Neuromuscular Electrical Stimulation Benefit the Functional Ability of Elderly Patients With Chronic Obstructive Lung Disease (NEMS for COPD)

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Rehabilitation; Chronic Obstructive Lung Disease; Neuromuscular Electrical Stimulation; Pulmonary Function (FEV1/FVC)
• Intervention / Treatment: Other: Control Group Chest physical therapy; Other: Study Group chest physiotherapy program combined with neuromuscular electrical stimulation (NMES)

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Qinā, Egypt
    • Department of P.T for internal medicine, Faculty of Physical Therapy, South valley university, Qena, Egypt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control Group; 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.	Other: 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; Other Names: Chest physical therapy
Experimental: Study Group; The patients in this group were received the same chest physiotherapy program combined with neuromuscular electrical stimulation (NMES) of gluteus max., quadriceps, and calf muscles performed for 30 min /day for five days a week for three consecutive weeks.	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.; Other Names: Chest physical therapy plus NMES

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Beni-Suef University
• Collaborators: South Valley University
• Investigators: Study Director: Ibrahim I. I Abu zaid, PhD, Department of P.T for internal medicine, Faculty of Physical Therapy, South valley university, Qena, Egypt

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2023
• Primary Completion (Actual): August 13, 2023
• Study Completion (Actual): August 13, 2023

Study Registration Dates

• First Submitted: April 2, 2023
• First Submitted That Met QC Criteria: May 1, 2023
• First Posted (Actual): May 3, 2023

Study Record Updates

• Last Update Posted (Actual): April 30, 2024
• Last Update Submitted That Met QC Criteria: April 29, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease Attributes; Chronic Disease; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: BeniSuefU_1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No