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

NCT05838911 | Completed

• 1 other identifier: BeniSuefU_1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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), femoral blood flow physical and pulmonary function in severe COPD Patients.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (1)

• Blood flow velocimetry measurement

  change from baseline to 3 weeks after intervention and 3 days as a follow-up

Study Arms (2)

Control Group

ACTIVE COMPARATOR

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

Study Group

EXPERIMENTAL

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)

Interventions

Study Group chest physiotherapy program combined with neuromuscular electrical stimulation (NMES) OTHER

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.

Also known as: Chest physical therapy plus NMES

Study Group

Control Group Chest physical therapy OTHER

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

Also known as: Chest physical therapy

Control Group

Eligibility Criteria

• Age: 65 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients with unstable angina pectoris.
• Progressive ventricular dysrhythmia.
• Intermittent claudication.
• Implanted cardiac pacemakers.
• Uncontrolled diabetes mellitus.
• Peripheral vascular disease.

Sponsors & Collaborators

• Beni-Suef University: lead
• South Valley University: collaborator

Study Sites (1)

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

Qina, Egypt

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ibrahim I. I Abu zaid, PhD

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer at faculty of physical therapy

Study Record Dates

• First Submitted: April 2, 2023
• First Posted: May 3, 2023
• Study Start: April 2, 2023
• Primary Completion: August 13, 2023
• Study Completion: August 13, 2023
• Last Updated: April 30, 2024

Record last verified: 2024-04

Locations

EG (1)