Clinical trial

Effects of Functional Strength Training and Neuromuscular Electrical Stimulation During Hospitalisation for Acute Exacerbation of Chronic Obstructive Pulmonary Disease: a Randomised Controlled Trial

Name

BOF20BL20

Description

Chronic obstructive pulmonary disease (COPD) is highly prevalent and frequently punctuated by severe acute exacerbations (AECOPD), defined as a temporary worsening of symptoms which leads to hospitalisation. AECOPD result in physical inactivity, muscle weakness and decreased exercise capacity, which impacts negatively on patients' health status, and increases patients' susceptibility for new exacerbations and death. To date, light aerobic exercises, such as early mobilisation and low-intensity ambulation, have become part of standard of care during severe AECOPD. Nevertheless, additional strength training using neuromuscular electrical stimulation and functional exercises, which have been shown to prevent skeletal muscle dysfunction whilst inducing minimal stress in the ventilatory system, might be of added value to optimize patients' functional performance and symptoms during activities at discharge. Therefore, this randomized controlled trial aims to evaluate the effectiveness of additional functional strength training and neuromuscular electrical stimulation on top of standard of care during hospitalisation for an AECOPD to enhance functional performance, symptoms of dyspnoea and fatigue during activities, and readmission rate.

Trial arms

Trial start

2022-06-01

Estimated PCD

2023-12-01

Trial end

2024-05-01

Status

Recruiting

Treatment

Functional strength training

Functional strength training will include lower limb (e.g. rising from chair, heel rises) and upper limb (e.g. push-ups from the chair and against the wall) exercises for 15 min/day. Target levels of dyspnoea and/or perceived exertion will be 4 to 6 in the modified Borg scale.

Arms:

Functional strength training + NMES

NMES

For neuromuscular electrical stimulation, electrodes will be placed longitudinally on the vastus intermedius and vastus medialis and a symmetric biphasic pulse waveform, with a pulse duration of 400ms, a frequency of 50Hz, in cycles of 8s of contraction and 20s of rest, will be used for 30min/day. The highest intensity tolerated by the patient will be used and intensity will be increased every time the patient feels comfortable with increasing the intensity. The device Compex Pro Rehab (CE-0473) will be used.

Arms:

Functional strength training + NMES

Daily medical treatment (e.g., oxygen, medrol, duovent, azitromycine)

Patients will be treated with daily medication prescribed by the physician, which can include oxygen, medrol, duovent, azitromycine or other medications that physicians consider that are needed.

Arms:

Functional strength training + NMES, Standard of care

Other names:

Medication

Routine physiotherapy

Daily sessions of approximately 15 minutes consisting of airway clearance techniques and breathing exercises upon indication, mobilization, and low-intensity daily walking/cycling exercise (5 to 10 minutes) according to patients' tolerance.

Arms:

Functional strength training + NMES, Standard of care

Size

Primary endpoint

1-minute sit-to-stand test

within 48 hours of hospital admission (baseline assessment)

Change in the 1-minute sit-to-stand test

within 48 hours of hospital admission (baseline assessment), at the day of hospital discharge (post assessment, usually up to 7 days after admission), 1 month after hospital discharge (1-month follow-up)

Eligibility criteria

Inclusion Criteria: * hospitalised due to an AECOPD according to the Global Initiative for Chronic Obstructive Lung Disease criteria * included within 48h of hospital admission * able to provide informed consent * dutch speaker Exclusion Criteria: * need for mechanical ventilation or admission in the intensive care unit * unstable cardiovascular disease * hospitalization in the previous month * significant musculoskeletal or neuromuscular impairment that precludes the performance of the tests or participation in the study * signs of cognitive impairment * current neoplastic or immunological disease * implantable electronic devices (e.g., pacemaker, implantable cardioverter defibrillator \[ICD\], cardiac resynchronization therapy \[CRT\] device) * sensitivity alterations

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}

Updated at

2023-10-23

1 organization

Organization

Hasselt University