EMS for COPD: Outcome Of Pulmonary Rehabilitation For Sever Chronic Obstructive Lung Disease Patients Undergoing Neuromuscular Electrical Stimulation

Sponsor
Beni-Suef University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05838911
Collaborator
South Valley University (Other)
60
1
2
2.9
20.5

Study Details

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 quadriceps and calf muscles to chest physiotherapy, compared to chest physiotherapy alone, on muscles strength (quadriceps and calf), femoral blood flow physical and pulmonary function in severe COPD Patients.

Condition or Disease Intervention/Treatment Phase
  • Other: Study Group chest physiotherapy program combined with neuromuscular electrical stimulation (NMES)
  • Other: Control Group Chest physical therapy
N/A

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 40-60 years. The mean ages of the study group (A) (Chest PT) were 47.4 ± 5.7 years and the study group (B) (Chest PT+NMES) are 47.4 ± 5.7 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 quadriceps and calf muscles performed for 30 min /day for five days a week for three consecutive weeks. Femoral blood Flow, quadriceps and calf muscles strength and pulmonary function (FEV1/FVC) will be measured for both groups pre and post treatment.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Outcome Of Pulmonary Rehabilitation For Severe Chronic Obstructive Lung Disease Patients Undergoing Neuromuscular Electrical Stimulation
Actual Study Start Date :
Apr 2, 2023
Anticipated Primary Completion Date :
May 30, 2023
Anticipated Study Completion Date :
Jun 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 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.

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
Other Names:
  • Chest physical therapy
  • Experimental: Study Group

    The patients in this group were received the same chest physiotherapy program combined with neuromuscular electrical stimulation (NMES) of 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)
    The patients in this group were received the same chest physiotherapy program combined with neuromuscular electrical stimulation of quadriceps and calf muscles performed for 30 min /day for five days a week for three consecutive weeks.
    Other Names:
  • Chest physical therapy plus NMES
  • Outcome Measures

    Primary Outcome Measures

    1. Muscle strength measurement [change from baseline to 3 weeks after intervention]

      To determine the maximal muscle strength the Lafayette manual muscle test system (USER MANUAL) (MMT) Model 01163, White Plains, New York (10602) of quadriceps and calf muscles were performed.

    2. Blood flow velocimetry measurement [change from baseline to 3 weeks after intervention]

      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 )

    3. Pulmonary function test [change from baseline to 3 weeks after intervention]

      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).

    4. respiratory muscle function test [change from baseline to 3 weeks after intervention]

      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

    1. Six-minute walking test [change from baseline to 3 weeks after intervention]

      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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of P.T for internal medicine, Faculty of Physical Therapy, South valley university, Qena, Egypt Qinā Egypt

    Sponsors and Collaborators

    • Beni-Suef University
    • South Valley University

    Investigators

    • Study Director: Ibrahim I. I Abu zaid, PhD, Department of P.T for internal medicine, Faculty of Physical Therapy, South valley university, Qena, Egypt

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ahmed Samir Abdelkhalik Youssef, lecturer at faculty of physical therapy, Beni-Suef University
    ClinicalTrials.gov Identifier:
    NCT05838911
    Other Study ID Numbers:
    • BeniSuefU_1
    First Posted:
    May 3, 2023
    Last Update Posted:
    May 3, 2023
    Last Verified:
    Apr 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 3, 2023