Inspiratory Muscle Training and Neuromuscular Electrical Stimulation in Chronic Obstructive Pulmonary Disease
- Conditions
- Chronic Obstructive Pulmonary Disease
- Interventions
- Device: Multimodal trainingDevice: Pulmonary RehabilitationDevice: IMT + Pulmonary RehabilitationDevice: NMES + Pulmonary Rehabilitation
- Registration Number
- NCT04387318
- Lead Sponsor
- Universidade Federal de Santa Maria
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Multimodal training Multimodal training 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. Pulmonary Rehabilitation Pulmonary Rehabilitation Pulmonary Rehabilitation: The physical training part of pulmonary rehabilitation will consist of aerobic and resistance exercise. IMT + Pulmonary Rehabilitation IMT + Pulmonary Rehabilitation 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. NMES + Pulmonary Rehabilitation NMES + Pulmonary Rehabilitation 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.
- Primary Outcome Measures
Name Time Method Static postural balance Post-intervention (change after 8 weeks of training) Static postural balance will be assessed on a portable force platform (AccuSway Plus, AMTI®, MA, USA) using the center of area of pressure and area of ellipse (AE) (cm2).
- Secondary Outcome Measures
Name Time Method Quadriceps femoris and diaphragm thickness Post-intervention (change after 8 weeks of training) Quadriceps femoris and diaphragm thickness will measured by ultrasonography
Oxidant profile Post-intervention (change after 8 weeks of training) The oxidant profile will be assessed by Total Oxidant Status - TOS (mmol Trolox Equiv/L).
Balance confidence questionnaire Post-intervention (change after 8 weeks of training) Balance confidence questionnaire will measured through Falls Efficacy Scale-International (total score points). The total score ranges from 16 to 64 points. Higher values indicate less fall-related self-efficacy (and more concern about falling).
Health-related quality of life at 8 week Post-intervention (change after 8 weeks of training) Health-related quality of life will measured by Saint George's Respiratory Questionnaire. Overall scores range from 0 (no effect on quality of life) to a maximum score of 100 (maximum perceived distress).
Antioxidant profile Post-intervention (change after 8 weeks of training) The antioxidant profile will be assessed by Total Antioxidant Capacity- CAT (mmol Trolox Equiv/L).
Static postural balance Post-intervention (change after 8 weeks of training) Static postural balance (%) will assessed through Foam-Laser dynamic posturography.
Dynamic postural balance Post-intervention (change after 8 weeks of training) Dynamic postural balance will assessed using the Timed Up and Go (seconds). A faster time indicate a better functional performance and a score of ≥12 seconds used as a cut-point.
Peripheral muscle strength Post-intervention (change after 8 weeks of training) Handgrip strength and quadriceps muscle strength will be assessed by dynamometry, respectively, Kgf and Newtons.
Muscle damage Post-intervention (change after 8 weeks of training) Muscle damage will assessed through lactate parameter (mg/dL).
Static and dynamic postural balance Post-intervention (change after 8 weeks of training) Static and dynamic postural balance will assessed using the Balance Evaluation Systems Test (score points). The total score of the test (108 points) will be calculated with a percentage score (0-100%) and higher scores indicate better balance performance.
Respiratory muscle strength and inspiratory muscle endurance Post-intervention (change after 8 weeks of training) Respiratory muscle strength (cmH2O) and inspiratory muscle endurance (cmH2O) will measured through digital pressure manometry and incremental and constant test, respectively
Submaximal level of functional capacity Post-intervention (change after 8 weeks of training) Submaximal level of functional capacity will measured by 6-minute walk test
DNA damage Post-intervention (change after 8 weeks of training) DNA damage will assessed by means of the Comet and micronucleus assay
Endothelial function Post-intervention (change after 8 weeks of training) Endothelial function will assessed through nitrite/nitrate oxide (NOx) (µmol/L)
Peripheral muscle resistance of the lower limbs Post-intervention (change after 8 weeks of training) Peripheral muscle resistance of the lower limbs will assessed through 30-second Sit-to-Stand tests (repetitions)
Trial Locations
- Locations (1)
Universidade Federal de Santa Maria
🇧🇷Santa Maria, Rio Grande Do Sul, Brazil