Effect of NMES on Quadriceps Muscle Strength and Endurance in Patients With COPD

Summary

Chronic Obstructive Pulmonary Disease (COPD) is a respiratory condition that results in a mixture of small airway disease and parenchymal destruction, changes that are characteristic of emphysema. COPD is also characterized by persistent airflow limitation, an aspect which is noted to be a major cause of morbidity and disease burden worldwide. One in every 8 patients who suffer an exacerbation requires to be admitted to the hospital. Due to repercussions that arise both because of the systemic effects of COPD and also the aggravating factors due to the exacerbation, new adjuncts to treatment are being researched. NMES is a non-invasive and non-addictive means of muscle contraction and was introduced as a rehabilitation means post muscle injury, surgery, and eventually in certain diseases and its use in the treatment of patients with COPD is being looked into.

This research study shall adopt a quantitative approach. A Randomised Control Trial (RCT) shall be used to investigate the effect of Neuromuscular Electrical Nerve Stimulation on quadriceps muscle strength and endurance. Approximately 103 patients shall be randomly enrolled in the control group and the experimental group. The control group shall receive Physiotherapy as already provided by physiotherapists including chest and mobility exercises. The experimental group shall undergo Physiotherapy with the addition of NMES. To assess the effect of NMES on quadriceps strength and endurance, quadriceps strength shall be tested through the use of a hand-held dynamometer. Endurance shall be tested through a quadriceps endurance test which requires the leg to be extended against a weight corresponding to 70% of the 1 repetition maximum with a pace of 12 movements per minute, a test which will be stopped when the patient can no longer perform the movement despite strong verbal prompting and encouragement and the standardised 1-minute sit-to-stand. All tests are to be conducted before the intervention, hence on admission to the local general hospital and prior discharge to a maximum of 30 days from the date of admission. All tests shall be done in the patients' ward setting. Also, a diagnostic ultrasound scan of this group of muscles shall be performed upon admission and before discharge by a consultant radiologist at the radiology department. The Borg scale shall be used to assess the shortness of breath of the patients following the 1-minute sit-to-stand.

Conditions

• Chronic Obstructive Pulmonary Disease Moderate
• Chronic Obstructive Pulmonary Disease Severe
• Acute Exacerbation of COPD

Interventions

DEVICE

Neuromuscular Electrical Nerve Stimulation

Application of NMES on quadriceps muscle groups bilaterally Frequency: \>50Hz Pulse duration: 350 - 400µs Intensity: Maximal tolerance (visible quadriceps muscle contraction and/or maximally tolerated by the patient, eliciting a slight discomfort) Time: 30 minutes per session, 7 sessions per week Duty Cycle: 2s on / 18s off Duration: Until discharge to a maximum of 30 days

OTHER

Usual Physiotherapy treatment (Chest Physiotherapy and mobility)

Daily chest physiotherapy and mobility

Sponsors & Collaborators

• University of Malta, Faculty of Health Sciences

  collaborator UNKNOWN

• Randall Debattista

  lead OTHER

Principal Investigators

• Dr. Tonio Agius, Physiotherapist · University of Malta, Faculty of Health Sciences

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

79 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-10-01

Primary Completion

2023-12-30

Completion

2024-05-30