Clinical trial NCT04387318: Inspiratory Muscle Training and Neuromuscular Electrical Stimulation in Chronic Obstructive Pulmonary Disease
Official title: Effects of Inspiratory Muscle Training and Neuromuscular Electrical Stimulation in Patients With Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: Universidade Federal de Santa Maria
Sponsor class: OTHER
First posted: 2020-05-13
Enrollment: 40
Sex: ALL
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Static postural balance
timeFrame: Post-intervention (change after 8 weeks of training)
measure: Static postural balance
timeFrame: Post-intervention (change after 8 weeks of training)
measure: Static postural balance
timeFrame: Post-intervention (change after 8 weeks of training)
measure: Static postural balance
timeFrame: Post-intervention (change after 8 weeks of training)
Secondary outcomes:
measure: Static postural balance
timeFrame: Post-intervention (change after 8 weeks of training)
measure: Static and dynamic postural balance
timeFrame: Post-intervention (change after 8 weeks of training)
measure: Static and dynamic postural balance
timeFrame: Post-intervention (change after 8 weeks of training)
measure: Dynamic postural balance
timeFrame: Post-intervention (change after 8 weeks of training)
measure: Balance confidence questionnaire
timeFrame: Post-intervention (change after 8 weeks of training)
measure: Balance confidence questionnaire
timeFrame: Post-intervention (change after 8 weeks of training)
measure: Peripheral muscle strength
timeFrame: Post-intervention (change after 8 weeks of training)
measure: Respiratory muscle strength and inspiratory muscle endurance
timeFrame: Post-intervention (change after 8 weeks of training)
measure: Quadriceps femoris and diaphragm thickness
timeFrame: Post-intervention (change after 8 weeks of training)
measure: Submaximal level of functional capacity
timeFrame: Post-intervention (change after 8 weeks of training)
measure: Health-related quality of life at 8 week
timeFrame: Post-intervention (change after 8 weeks of training)
measure: Oxidant profile
timeFrame: Post-intervention (change after 8 weeks of training)
measure: Oxidant profile
timeFrame: Post-intervention (change after 8 weeks of training)
measure: Oxidant profile
timeFrame: Post-intervention (change after 8 weeks of training)
measure: Oxidant profile
timeFrame: Post-intervention (change after 8 weeks of training)
measure: Antioxidant profile
timeFrame: Post-intervention (change after 8 weeks of training)
measure: Antioxidant profile
timeFrame: Post-intervention (change after 8 weeks of training)
measure: Muscle damage
timeFrame: Post-intervention (change after 8 weeks of training)
measure: Muscle damage
timeFrame: Post-intervention (change after 8 weeks of training)
measure: Muscle damage
timeFrame: Post-intervention (change after 8 weeks of training)
measure: DNA damage
timeFrame: Post-intervention (change after 8 weeks of training)
measure: Endothelial function
timeFrame: Post-intervention (change after 8 weeks of training)
measure: Peripheral muscle resistance of the lower limbs
timeFrame: Post-intervention (change after 8 weeks of training)
Other outcomes:
Locations:
city: Santa Maria
country: Brazil
facility: Universidade Federal de Santa Maria
state: Rio Grande Do Sul
Study officials:
affiliation: Universidade Federal de Santa Maria
name: Isabella Albuquerque, DSc
role: STUDY_CHAIR
affiliation: Universidade Federal de Santa Maria
name: Tamires dos Santos, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidade Federal de Santa Maria
name: Aron Silveira, DSc
role: STUDY_CHAIR
References: