Effects of Functional Strength Training and Neuromuscular Electrical Stimulation During Hospitalisation for Acute Exacerbation of Chronic Obstructive Pulmonary Disease: a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Change in the 1-minute sit-to-stand test
研究概览
简要总结
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.
详细描述
Chronic obstructive pulmonary disease (COPD) is a progressive and life-threatening condition characterised by persistent respiratory symptoms and airflow limitation. It affects 384 million people, is one of the main causes of morbidity and the third cause of mortality worldwide, responsible for around 3 million deaths annually. Consequently, COPD results in significant and increasing health, economic and social burden. The trajectory of COPD is frequently punctuated by acute exacerbations (AECOPD), defined as episodes of acute worsening of respiratory symptoms that result in additional therapy.
Severe AECOPD lead to hospitalization and account for more than 70% of all COPD-related costs. AECOPD are associated with physical inactivity, quadriceps muscle weakness and decreased exercise capacity, which impacts negatively on patients' health status, and increases patients' susceptibility for exacerbations recurrence, hospitalisations and death. Therefore, minimising the negative sequelae of AECOPD and preventing rehospitalisation are fundamental treatment goals for individuals, families and health, economic and social systems.
People discharged from the hospital after an AECOPD benefit from participating in pulmonary rehabilitation, but uptake is generally low. By all means, however, it is important to maximize the patient's functional performance and minimize symptoms during activities by the time of discharge. During an AECOPD, patients experience increased dyspnoea. Consequently, exercise modalities with minimal ventilatory requirements are preferred. To date, light aerobic exercises, such as early mobilisation and low-intensity ambulation, have become part of the standard of care. Nevertheless, additional strength training using neuromuscular electrical stimulation (NMES) 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 at discharge.
The researchers hypothesise that adding functional strength training and NMES to the standard mobilisation practice during hospitalisation for an AECOPD will: i) preserve or enhance patients' functional performance; ii) reduce symptoms of dyspnoea and fatigue and iii) decrease the short-term readmission rate.
Therefore, this study aims to evaluate the impact of adding functional strength training and NMES to standard mobilisation practice during hospitalisation for an AECOPD on:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Standard of care
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.
干预措施: Routine physiotherapy (Other)
Functional strength training + NMES
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.
干预措施: Functional strength training (Other)
Functional strength training + NMES
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.
干预措施: NMES (Device)
Functional strength training + NMES
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.
干预措施: Daily medical treatment (e.g., oxygen, medrol, duovent, azitromycine) (Drug)
Functional strength training + NMES
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.
干预措施: Routine physiotherapy (Other)
Standard of care
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.
干预措施: Daily medical treatment (e.g., oxygen, medrol, duovent, azitromycine) (Drug)
结局指标
主要结局
Change in the 1-minute sit-to-stand test
时间窗: 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)
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.
1-minute sit-to-stand test
时间窗: within 48 hours of hospital admission (baseline assessment)
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.
次要结局
- 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))
- Number of new exacerbation-related hospitalisations(6 months after hospital discharge)
- 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))
- Change in the COPD Assessment Test (CAT)(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 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 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 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))
研究者
Chris Burtin
Assistant Professor
Hasselt University