Clinical trial NCT05838911: Does Neuromuscular Electrical Stimulation Benefit the Functional Ability of Elderly Patients With Chronic Obstructive Lung Disease
Official title: Does Neuromuscular Electrical Stimulation Benefit the Functional Ability of Elderly Patients With Chronic Obstructive Lung Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Rehabilitation
Chronic Obstructive Lung Disease
Neuromuscular Electrical Stimulation
Pulmonary Function (FEV1/FVC)
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
Collaborators: name: South Valley University
First posted: 2023-05-03
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Maximum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Six-minute walking test (Physical function assessment
timeFrame: change from baseline to 3 weeks after intervention and 3 days as a follow-up
measure: Pulmonary function test
timeFrame: change from baseline to 3 weeks after intervention and 3 days as a follow-up
measure: Muscle strength measurement
timeFrame: change from baseline to 3 weeks after intervention and 3 days as a follow-up
Secondary outcomes:
measure: Blood flow velocimetry measurement
timeFrame: change from baseline to 3 weeks after intervention and 3 days as a follow-up
Other outcomes:
Locations:
city: Qinā
country: Egypt
facility: Department of P.T for internal medicine, Faculty of Physical Therapy, South valley university, Qena, Egypt
Study officials:
affiliation: Department of P.T for internal medicine, Faculty of Physical Therapy, South valley university, Qena, Egypt
name: Ibrahim I. I Abu zaid, PhD
role: STUDY_DIRECTOR
References: