Functional Strength Training and Neuromuscular Electrical Stimulation in Severe Acute Exacerbations of COPD

NCT05480566 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2025-09-15

No results posted yet for this study

Summary

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.

Conditions

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

Interventions

OTHER

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.

DEVICE

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.

DRUG

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.

OTHER

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.

Sponsors & Collaborators

  • Hasselt University

    lead OTHER

Principal Investigators

  • Chris Burtin, PhD · Rehabilitation Research Center (REVAL), Faculty of Rehabilitation Sciences, Hasselt University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-01
Primary Completion
2023-12-01
Completion
2023-12-01

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05480566 on ClinicalTrials.gov