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

NCT05480566 | Terminated

• 1 other identifier: BOF20BL20
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Acute exacerbation of chronic obstructive pulmonary disease; Inpatient; Functional strength training; NMES

Outcome Measures

Primary Outcomes (2)

• 1-minute sit-to-stand test

  Functional performance (the primary outcome) will be measured with the 1-minute sit-to-stand test, which is a valid, reliable and responsive test to assess this outcome in patients with chronic obstructive pulmonary disease (COPD). A straight-backed armless chair of 46-48 centimeters, with a hard seat, stabilized against a wall will be used to perform the test. Participants will be asked to sit with their hands stationary on the hips, without using the hands or arms to assist movement and instructed to stand up all the way and sit down, as many times as possible, in 1 minute. The protocol described by Crook et al will be followed. Since this test presents no learning effect, only one measurement will be asked in each timepoint.

  within 48 hours of hospital admission (baseline assessment)

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

  Functional performance (the primary outcome) will be measured with the 1-minute sit-to-stand test, which is a valid, reliable and responsive test to assess this outcome in patients with chronic obstructive pulmonary disease (COPD). A straight-backed armless chair of 46-48 centimeters, with a hard seat, stabilized against a wall will be used to perform the test. Participants will be asked to sit with their hands stationary on the hips, without using the hands or arms to assist movement and instructed to stand up all the way and sit down, as many times as possible, in 1 minute. The protocol described by Crook et al will be followed. Since this test presents no learning effect, only one measurement will be asked in each timepoint.

  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)

Secondary Outcomes (7)

• Change in Isometric quadriceps strength

  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)

• Change in Handgrip strength

  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)

• Change in the modified British Medical Research Council dyspnoea questionnaire (mMRC)

  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)

• Change in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)

  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)

• Change in the London chest activities of daily living questionnaire (LCADL)

  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)

Other Outcomes (8)

• Change in Daily physical activity

  During hospitalization (i.e., from hospital admission until hospital discharge), at 1-month follow-up (i.e., 1-month after hospital discharge)

• Change in Body mass index

  within 48 hours of hospital admission (baseline assessment), 1 month after hospital discharge (1-month follow-up)

• Change in Heart rate

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

Study Arms (2)

Functional strength training + NMES

EXPERIMENTAL

The experimental group will receive the standard of care plus functional strength training and quadriceps neuromuscular electrical stimulation. 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. 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.

Other: Functional strength training; Device: NMES; Drug: Daily medical treatment (e.g., oxygen, medrol, duovent, azitromycine); Other: Routine physiotherapy

Standard of care

ACTIVE COMPARATOR

The standard of care group will receive the common treatment delivered at the hospital, i.e., routine medical treatment and 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.

Drug: Daily medical treatment (e.g., oxygen, medrol, duovent, azitromycine); Other: Routine physiotherapy

Interventions

Functional strength training OTHER

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.

Functional strength training + NMES

NMES DEVICE

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.

Functional strength training + NMES

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

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.

Also known as: Medication

Functional strength training + NMES; Standard of care

Routine physiotherapy OTHER

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.

Functional strength training + NMES; Standard of care

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hasselt University: lead

Study Sites (1)

Ziekenhuis Oost-Limburg

Genk, Belgium

Location

MeSH Terms

Interventions

Oxygen; Methylprednisolone; fenoterol, ipratropium drug combination; Dosage Forms

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Gases; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Pharmaceutical Preparations; Technology, Pharmaceutical; Investigative Techniques

Study Officials

• Chris Burtin, PhD

  Rehabilitation Research Center (REVAL), Faculty of Rehabilitation Sciences, Hasselt University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 21, 2022
• First Posted: July 29, 2022
• Study Start: June 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)