Inspiratory Muscle Training and Neuromuscular Electrical Stimulation in Chronic Obstructive Pulmonary Disease
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      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.
    


Intervention name(s): Multimodal training; IMT + Pulmonary Rehabilitation; NMES + Pulmonary Rehabilitation; Pulmonary Rehabilitation
Intervention type(s): Device; Device; Device; Device
Intervention description(s): IMT will be performed using the POWERbreathe® Medic Plus inspiratory training device for five sets of 10 repetitions each, with a one-minute interval between each set. The initial load set will be 30% of maximal inspiratory pressure (MIP), during the first two weeks to allow for an adjustment period. The IMT wil be performed two times per week for 8 weeks.
NMES will be applied using an calibrated electrical stimulator (Neurodyn High Volt, IBRAMED, São Paulo/São Paulo, Brazil). The following parameters will be used: 50 Hz frequency, pulse duration of 400 µs, work cycle of 5 seconds ON and 15 seconds OFF (first month) adjusted for 10 seconds ON and 30 seconds OFF (second month) and maximum intensity tolerated during 2 times per week for 8 weeks.
Pulmonary Rehabilitation The pulmonary rehabilitation will consist of aerobic and resistance exercise during 8 weeks.; IMT will be performed using the POWERbreathe® Medic Plus (POWERbreathe Medic Plus ®, SP, BR) inspiratory training device for five sets of 10 repetitions each, with a one-minute interval between each set. The initial load set will be 30% of maximal inspiratory pressure (MIP), during the first two weeks to allow for an adjustment period. After that, load increases occurred as follows: 35% of MIP in week 3, 40% of MIP in week 4, 45% of MIP in week 5, 50% of MIP at week 6, 55% of MIP in week 7, and 60% of MIP in weeks 8.
Pulmonary Rehabilitation The pulmonary rehabilitation will consist of aerobic and resistance exercise during 8 weeks.; NMES will be applied using an calibrated electrical stimulator (Neurodyn High Volt, IBRAMED, São Paulo/São Paulo, Brazil). The following parameters will be used: 50 Hz frequency, pulse duration of 400 µs, work cycle of 5 seconds ON and 15 seconds OFF (first month) adjusted for 10 seconds ON and 30 seconds OFF (second month) and maximum intensity tolerated during 2 times per week for 8 weeks.
Pulmonary Rehabilitation The pulmonary rehabilitation will consist of aerobic and resistance exercise during 8 weeks.; Pulmonary Rehabilitation The pulmonary rehabilitation will consist of aerobic and resistance exercise during 8 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment