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

Study Overview
=================
Brief 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 and anterior tibial group), femoral blood flow physical and pulmonary function in severe COPD Patients.

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 and anterior tibial group 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.

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

Conditions
-----------------
Pulmonary Rehabilitation, Chronic Obstructive Lung Disease, Neuromuscular Electrical Stimulation, Pulmonary Function (FEV1/FVC)

Intervention / Treatment
-----------------
* Other: Study Group chest physiotherapy program combined with neuromuscular electrical stimulation (NMES)
* Other: Control Group Chest physical therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control Group<br>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<br>* 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<br>* Other names: Chest physical therapy;|
| Experimental: Study Group<br>The patients in this group were received the same chest physiotherapy program combined with neuromuscular electrical stimulation (NMES) of gluteus max., quadriceps, calf muscles and anterior tibial group 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)<br>* The patients in this group were received the same chest physiotherapy program combined with neuromuscular electrical stimulation of gluteus max., quadriceps, calf muscles and anterior tibial group performed for 30 min /day for five days a week for three consecutive weeks.<br>* 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 were performed. | change from baseline to 3 weeks after intervention | 
| 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 | 
| Pulmonary function test | Spirometric tests were performed using the CPF System (Medical Graphics-MGC, St. Paul, MN) with airflow being measured by a calibrated Pitot tube (PreVent, Pneumotach). | change from baseline to 3 weeks after intervention | 
| respiratory muscle function test | The subjects completed at least three acceptable maximal forced and slow expiratory maneuvers after 15 min the inhalation of 400 mg of salbutamol via a metered-dose inhaler. Forced vital capacity (FVC, L), forced expiratory volume in one second (FEV1, L), FEV1/ FVC, and inspiratory capacity (IC) were measured according to American Thoracic Society standards. | change from baseline to 3 weeks after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Six-minute walking test | 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 |