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

NCT05539547 | Unknown Early Phase 1

• 1 other identifier: FHS-2021-00004
• Study Type: interventional
• Target: 140
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

COPD; NMES; Quadriceps; Rectus Femoris; Strength; Endurance

Outcome Measures

Primary Outcomes (2)

• Change in Quadriceps Strength

  hand-held dynamometer shall be used to determine the muscle strength present before and after the intervention of the quadriceps muscle, irrespective of which group the patient is randomly enrolled to. Three readings shall be taken on each leg with the average recorded. Patients will sit at the edge of a bed, with the bed slightly elevated so that the lower limbs were in no time not in contact with the ground provided that the patient has sufficient static sitting balance.

  Week 0 and up to 30 days

• Change in Quadriceps Endurance using the Quadriceps Endurance Testing

  2\. Quadriceps Endurance test: The quadriceps endurance test is performed with the patient sitting on a chair (White et a., 2013) with the starting position of 90 degrees knee and hip flexion with both arms crossed over the chest. The test consists of extending the dominant leg against weight corresponding to 70% of 1 repetition maximum with a pace of 12 movements per minute until exhaustion. The test shall stop when the participants could no longer follow the movements despite strong verbal prompting and encouragement. The duration is then recorded as the quadriceps endurance limit time (TlimQ, seconds).

  Week 0 and up to 30 days

Secondary Outcomes (5)

• Change in 1 Minute Sit-to-stand

  Week 0 and up to 30 days

• Change in COPD Assessment Test Score (CAT Score)

  Week 0 and up to 30 days

• Change in the Medical Research Council (MRC) dyspnoea scale

  Week 0 and up to 30 days

• Change in the Dyspnoea Breathlessness scale (Borg Dyspnoea Scale)

  Week 0 and up to 30 days

• Change in quadriceps muscle length and width

  Week 0 and up to 30 days

Study Arms (2)

Control Group

SHAM COMPARATOR

Patients shall receive the usual physiotherapy care, including chest and mobility physiotherapy on quadriceps strength and endurance during hospital admission on patients with severe acute exacerbation COPD.

Other: Usual Physiotherapy treatment (Chest Physiotherapy and mobility)

Experimental Group

EXPERIMENTAL

Patients shall receive the investigated modality, NMES on quadriceps strength and endurance as an adjunct to usual physiotherapy care (chest physiotherapy and mobility) during hospital admission in patients with severe acute exacerbation COPD.

Device: Neuromuscular Electrical Nerve Stimulation

Interventions

Neuromuscular Electrical Nerve Stimulation DEVICE

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

Experimental Group

Usual Physiotherapy treatment (Chest Physiotherapy and mobility) OTHER

Daily chest physiotherapy and mobility

Control Group

Eligibility Criteria

• Age: 40 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females between the age of 40 - 79
• Confirmed diagnosis of an Acute Exacerbation of COPD
• MRC Dyspnoea score of 4 or above

You may not qualify if:

• Any locomotor or neurological conditions
• Malignancy or recent history of malignancy
• Cardiac failure, pacemaker, and implantable cardioverter-defibrillator (ICD)
• Distal arteriopathy, venous thromboembolism
• Disabilities or recent orthopedic surgeries

Sponsors & Collaborators

• Randall Debattista: lead
• University of Malta, Faculty of Health Sciences: collaborator

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Range of Motion, Articular

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Dr. Tonio Agius, Physiotherapist

  University of Malta, Faculty of Health Sciences

  STUDY CHAIR

Central Study Contacts

Randall Debattista, Physiotherapist

CONTACT

+35679951305; randalldebattista@gmail.com

Dr. Anabel Sciriha, Physiotherapist

CONTACT

2340 1573; anabel.sciriha@um.edu.mt

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Master (By Research) Student

Model Details: This study consists of the enrolment of two groups concurrently both receiving the usual physiotherapy treatment with the addition of NMES to the experimental group. Control Group: Effect of usual physiotherapy care, including chest and mobility physiotherapy on quadriceps strength and endurance during hospital admission on patients with severe acute exacerbation COPD. Experimental Group: Effect of NMES on quadriceps strength and endurance as an adjunct to usual physiotherapy care (chest physiotherapy and mobility) during hospital admission in patients with severe acute exacerbation COPD.

Study Record Dates

• First Submitted: September 4, 2022
• First Posted: September 14, 2022
• Study Start: October 1, 2022
• Primary Completion: December 30, 2023
• Study Completion: May 30, 2024
• Last Updated: September 14, 2022

Record last verified: 2022-09