Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05539547 |
| Other study ID # |
FHS-2021-00004 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
Early Phase 1
|
| First received |
|
| Last updated |
|
| Start date |
October 1, 2022 |
| Est. completion date |
May 30, 2024 |
Study information
| Verified date |
September 2022 |
| Source |
University of Malta |
| Contact |
Randall Debattista, Physiotherapist |
| Phone |
+35679951305 |
| Email |
randalldebattista[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
Chronic Obstructive Pulmonary Disease (COPD) is a respiratory condition that results in a
mixture of small airway disease and parenchymal destruction, changes which are characteristic
of emphysema. Research showed that COPD is also characterized by persistent airflow
limitation, an aspect which some authors noted to be a major cause of morbidity and disease
burden worldwide. One in every 8 patients who suffer an exacerbation of COPD requires to be
admitted to the hospital. Literature also reported that re-admissions following discharge
amounted to more than 20% within the first 20 days and continued to increase to approximately
33% within the first 90 days post-discharge from the hospital. Therefore, given that a high
portion of patients will require further hospitalisations, this will impose a financial
burden on the health care systems.
It emphasized the fact that apart from the pulmonary changes and respiratory impairments,
patients diagnosed with COPD have systemic morphological and biomechanical changes.
Morphological changes include a reduction in the cross-sectional area and a reduction in
muscle mass. Biochemical changes are primarily due to long-term use of steroids and Chronic
Systemic Inflammatory Syndrome (CSIS). Given such changes, more energy is required during
activities of daily living (ADLs) by such patients, resulting in shortness of breath (SOB)
following minimal exercises.
Due to muscle dysfunction, these patients develop physical deconditioning which is one of the
primary symptoms reported. The primary cause of this relates to the ventilatory limitations
present.
The severity of the condition and related pathophysiological changes also predict the level
of exercise tolerance, with a worse condition resulting in increased levels of muscle
atrophy, weakness affecting mostly the lower limbs, and poor oxidative capacity. In 2008, it
was noted that the majority of patients with a severe form of COPD were so frail or
dyspnoeic, making them unable to tolerate sufficient exercise training intensities required
to improve their level of physical activity. Such patients were noted to become dyspnoeic
following low-intensity physical activity, resulting in a decreased physical activity to
control their SOB, with ultimately one-third of these patients exhibiting quadriceps muscle
weakness related to immobility and decreased exercise tolerance.
Deterioration in muscle strength was the most commonly reported symptom characteristic of
limb muscle dysfunction in people with COPD. In 2014, Mathur et al. noted that the occurrence
of COPD patients experiencing early termination of exercise related to leg fatigue was
approximately 40% more common than patients rating of SOB. A further 30% of the population
sample reported equal leg fatigue and dyspnoea.
The higher the number of patients with COPD that become immobile, the more muscle mass is
lost, and this loss continues to increase in periods of hospitalisation due to an
exacerbation. Gosselink and Langer (2016) stated that immobility and inactivity both
considerably contributed to muscle atrophy via the term "mechanical silencing".
Fear and immobility during and or exactly after an AECOPD also play a huge role in quadriceps
strength. The deterioration in physical activity and muscle strength, primarily quadriceps
muscle was noted throughout the course of the disease. It is further evident during the
hospitalisation phase due to an acute onset of COPD.
Research has now changed its course of direction to find new methods and modalities which can
assist COPD patients in maintaining some form of muscle activity even during their weakest
days. Neuromuscular Electrical Nerve Stimulation (NMES) has been the most researched modality
in combination with Pulmonary Rehabilitation (PR) with a variation in parameters use and
duration of application.
NMES is a non-invasive means of muscle contraction and was introduced as a way for
rehabilitation post muscle injury, surgery and eventually in certain diseases. NMES involves
placing a conductive pad over the muscle and uses an intermittent electrical current to
trigger action potentials and activate the intramuscular nerve branches and muscle fibres to
generate a strong muscle contraction. It is a device which is self-administered, does not
require supervision and carries a low metabolic load, providing an acceptable therapy for
patients with a high symptom burden.
Therefore, after reviewing the above-mentioned gaps in literature where NMES is emerging as a
promising modality in assisting patients with an exacerbating episode of COPD.
Methodology
To answer the research question stated above, a Randomised Control Trial (RCT) type of study
design shall be adopted. An RCT is a study where participants are randomly assigned to an
experimental and control group. As the study is conducted, the only expected difference
between the control and experimental groups in a randomized controlled trial is the outcome
variable being studied. This is important to approximate a controlled experiment, decrease
bias and also improve statistical efficiency. In this research study, quadriceps strength,
and endurance are the primary outcome variables. With the CAT and changes in rectus femoris,
thickness and width through diagnostic ultrasound shall act as the secondary outcome
measures.
Data collection shall focus on measuring quadriceps strength and assessing for structural
changes, changes in the number of sit-to-stand repetitions for a duration of 1 minute and
changes in the COPD Assessment Test (CAT) score. Patients shall be asked to carry out these
tests on admission and on the same day of discharge from the hospital. A quantitative
analysis will follow to determine whether NMES affected quadriceps muscle strength and
endurance during an acute exacerbation of COPD. Concurrently, the same quantitative approach
will be used to determine the severity of the patients admitted with an AECOPD to the
hospital, alongside the level of anxiety and depression related to the chronic condition.
This research study will adopt a randomized-experimental research trial. Patients will be
randomly assigned into two groups, the control group and the experimental group through an
unpredicted randomised sequence and implementing the sequence that conceals the treatment
until the patients are formally assigned to their groups. The control group shall receive the
usual physiotherapy treatment currently offered to these patients in the ward setting by
physiotherapists responsible for their care. Participants shall be given a unique code before
the commencement of the study. All must have been previously diagnosed with COPD according to
the Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD) criteria which means
that patients were presented with a Forced Expiratory Flow in one second (FEV1) of <70% of
the predicted value and a Forced Expiratory Flow in one second to Forced Vital Capacity
(FEV1: FVC) of <0.70.
Intervention
All patients enrolled will be randomly assigned into two groups, the control group and the
experimental group. Every participant shall be given a code before the commencement of the
study. The code will only be known to the researcher and the supervisor, the latter having no
access to the computer used for data collection. The control group shall receive the usual
physiotherapy treatment in their respective wards. The patients enrolled on the experimental
group will have the usual physiotherapy treatment with the addition of NMES throughout their
hospital stay. Electrodes shall be placed on the quadriceps group of muscles, bilaterally and
concurrently.
Muscle stimulation is achieved using a portable stimulator, which can generate electrical
pulses. The electrodes must be placed over the motor point of the muscle or muscle group to
be stimulated. Amplitude, rate and waveform, which can also be referred to as the stimulus
parameters, are adjusted to facilitate quality of movement and contraction without the muscle
being fatigued throughout the treatment session (Hultman et al., 1983). NMES is described as
an easy-to-use, easy-to-read and comfortable apparatus where the parameters are adjustable to
the patient's progression, and programme recognition can be easily used by the patient.
These parameters have been chosen based on reports that concluded that a frequency of more
than 50Hz stimulates cause a tetanic fusion, thus stimulating muscle contraction. Various
other studies also supported such parameters
Ethical Considerations
Ethical approval was sought and approved by the University of Malta Research Ethics Committee
(UREC). Patients will be instructed about the study through verbal and written information
letters and consent will be requested. Informed consent will be needed from the participants
and will be allowed to quit the research study when desired. All the data that will be
collected regarding the patient will only be used for this study. All information gathered
before and after the research study will be discarded upon completion.
