Inspiratory Muscle Training and Neuromuscular Electrical Stimulation in Chronic Obstructive Pulmonary Disease

Universidade Federal de Santa Maria

Status: Completed

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Device: Multimodal training; Device: IMT + Pulmonary Rehabilitation; Device: Pulmonary Rehabilitation; Device: NMES + Pulmonary Rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT04387318

08527219.0.0000.5346

Details and patient eligibility

About

Chronic obstructive pulmonary disease (COPD) is a significant current public health problem, characterized by the presence of limited airflow. However, COPD has important manifestations beyond the lungs, the so-called systemic effects. These included dysfunction of peripheral and respiratory muscles. The growing amount of evidence has shown that patients with COPD also present important deficits in postural balance and consequently, increased risk of falling. As an essential part of the management of COPD, pulmonary rehabilitation (PR) alleviates dyspnea and fatigue, improves exercise tolerance and health-related quality of life, and reduces hospital admissions and mortality for COPD patients. Exercise is the key component of PR, which is composed of exercise assessment and training therapy. Currently, two modalities of therapy have been suggested as complementary to pulmonary rehabilitation: inspiratory muscular training (IMT) and neuromuscular electrical stimulation (NMES). Based on the premise that peripheral and respiratory muscle dysfunction can negatively impact postural control of patients with COPD, and given the importance of balance as a modifiable risk factor for falls, it is important to investigate whether the use of these therapeutic modalities (IMT and/or NMES) is capable of improving the short-term effects of pulmonary rehabilitation and also promoting improved balance.

Enrollment: 40 patients

Sex: All

Ages: 55 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of COPD, in stages II, III and IV, according to criteria of the Global Initiative for COPD (GOLD);
• Clinically stable, i.e., absence of infections or exacerbations in the last 3 months;
• Medical team allows patient to exercise
• Availability of attending the rehabilitation program.

Exclusion criteria

• Unstable primary pathologies (cardiovascular, renal, metabolic, psychiatric);
• Hemodynamic instability;
• Nutritional supplementation on the 4 weeks preceding the study;
• Severe hearing or visual impairment recorded on patient chart or self-referred;
• Obesity (BMI > 30 kg/m2);
• Neurological or musculoskeletal condition that severely limits mobility and postural control, thus making it impossible to carry out the assessments;
• Electronic devices, such as heart pacemakers and implantable cardioverter defibrillator;
• Skin injuries and infection where electrodes would be placed;
• Prior participation in pulmonary rehabilitation programs 3 months previous to the study;
• Vertigo;
• Active smoker and/or alcoholic;
• Neurological impairment or cerebellar lesions;
• Deficit in cognitive function;
• Severe vitamin D deficiency;
• Physically active.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 4 patient groups, including a placebo group

Multimodal training

Experimental group

Description:

IMT + NMES + Pulmonary Rehabilitation IMT will be performed using a device with linear load pressure (POWERbreathe Medic Plus ®, SP, BR). NMES will be applied using an calibrated electrical stimulator (Neurodyn High Volt, IBRAMED, São Paulo/São Paulo, Brazil). Pulmonary Rehabilitation: The physical training part of pulmonary rehabilitation will consist of aerobic and resistance exercise.

Treatment:

Device: Multimodal training

IMT + Pulmonary Rehabilitation

Experimental group

Description:

IMT will be performed using a device with linear load pressure (POWERbreathe Medic Plus ®, SP, BR). Pulmonary Rehabilitation: The physical training part of pulmonary rehabilitation will consist of aerobic and resistance exercise.

Treatment:

Device: IMT + Pulmonary Rehabilitation

NMES + Pulmonary Rehabilitation

Experimental group

Description:

NMES will be applied using an calibrated electrical stimulator (Neurodyn High Volt, IBRAMED, São Paulo/São Paulo, Brazil). Pulmonary Rehabilitation: The physical training part of pulmonary rehabilitation will consist of aerobic and resistance exercise.

Treatment:

Device: NMES + Pulmonary Rehabilitation

Pulmonary Rehabilitation

Placebo Comparator group

Description:

Pulmonary Rehabilitation: The physical training part of pulmonary rehabilitation will consist of aerobic and resistance exercise.

Treatment:

Device: Pulmonary Rehabilitation