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

NCT ID: NCT05838911

Last Updated: 2024-04-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-02
• Study Completion Date: 2023-08-13

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.

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Control Group Chest physical therapy

Intervention Type: 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

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.

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Interventions

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.

Intervention Type: 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

Intervention Type: OTHER

Other Intervention Names

Chest physical therapy plus NMES; Chest physical therapy

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.

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

South Valley University

OTHER

Sponsor Role: collaborator

Beni-Suef University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Samir Abdelkhalik Youssef

lecturer at faculty of physical therapy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ibrahim I. I Abu zaid, PhD

Role: STUDY_DIRECTOR

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

Locations

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

Qina, , Egypt

Countries

Egypt

Other Identifiers

BeniSuefU_1

Identifier Type: -

Identifier Source: org_study_id