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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05838911
Acronym
NEMS for COPD
Enrollment
60
Registered
2023-05-03
Start date
2023-04-02
Completion date
2024-02-13
Last updated
2026-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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 muscle strength (gluteus max., quadriceps, calf muscles), 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 8 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 8 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, then after 3 months follow up.

Interventions

OTHERStudy 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 8 consecutive weeks.

OTHERControl 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 8 consecutive weeks

Sponsors

Beni-Suef University
Lead SponsorOTHER
South Valley University
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
65 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Six-minute walking test (Physical function assessmentchange from baseline to 8 weeks after intervention and 3 months as a follow-upThe 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
Pulmonary function testchange from baseline to 8 weeks after intervention and 3 months as a follow-upPulmonary 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
Muscle strength measurementchange from baseline to 8 weeks after intervention and 3 months as a follow-upTo 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.

Secondary

MeasureTime frameDescription
Blood flow velocimetry measurementchange from baseline to 8 weeks after intervention and 3 months as a follow-upTo evaluate changes in peripheral perfusion. The standard pulsed-wave Doppler velocimetry of the right femoral artery was performed using sonos 2000 echograph (Philips Envisor )

Countries

Egypt

Contacts

STUDY_DIRECTORIbrahim I. I Abu zaid, PhD

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 19, 2026