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

Primary Purpose

Pulmonary Rehabilitation, Chronic Obstructive Lung Disease, Neuromuscular Electrical Stimulation

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Study Group chest physiotherapy program combined with neuromuscular electrical stimulation (NMES)
Control Group Chest physical therapy
Sponsored by
Beni-Suef University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Rehabilitation

Eligibility Criteria

65 Years - 75 Years (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control Group

Study Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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 )
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).
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.

Secondary Outcome Measures

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

Full Information

First Posted
April 2, 2023
Last Updated
August 12, 2023
Sponsor
Beni-Suef University
Collaborators
South Valley University
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1. Study Identification

Unique Protocol Identification Number
NCT05838911
Brief Title
Does Neuromuscular Electrical Stimulation Benefit the Functional Ability of Elderly Patients With Chronic Obstructive Lung Disease
Acronym
NEMS for COPD
Official Title
Does Neuromuscular Electrical Stimulation Benefit the Functional Ability of Elderly Patients With Chronic Obstructive Lung Disease
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
April 2, 2023 (Actual)
Primary Completion Date
May 30, 2023 (Actual)
Study Completion Date
August 13, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beni-Suef University
Collaborators
South Valley University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Rehabilitation, Chronic Obstructive Lung Disease, Neuromuscular Electrical Stimulation, Pulmonary Function (FEV1/FVC)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Study Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Study Group chest physiotherapy program combined with neuromuscular electrical stimulation (NMES)
Other Intervention Name(s)
Chest physical therapy plus NMES
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control Group Chest physical therapy
Other Intervention Name(s)
Chest physical therapy
Intervention Description
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
Primary Outcome Measure Information:
Title
Muscle strength measurement
Description
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.
Time Frame
change from baseline to 3 weeks after intervention
Title
Blood flow velocimetry measurement
Description
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 )
Time Frame
change from baseline to 3 weeks after intervention
Title
Pulmonary function test
Description
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).
Time Frame
change from baseline to 3 weeks after intervention
Title
respiratory muscle function test
Description
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.
Time Frame
change from baseline to 3 weeks after intervention
Secondary Outcome Measure Information:
Title
Six-minute walking test
Description
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
Time Frame
change from baseline to 3 weeks after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ibrahim I. I Abu zaid, PhD
Organizational Affiliation
Department of P.T for internal medicine, Faculty of Physical Therapy, South valley university, Qena, Egypt
Official's Role
Study Director
Facility Information:
Facility Name
Department of P.T for internal medicine, Faculty of Physical Therapy, South valley university, Qena, Egypt
City
Qinā
Country
Egypt

12. IPD Sharing Statement

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

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