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Clinical Trials/NCT04387318
NCT04387318
Completed
Not Applicable

Effects of Inspiratory Muscle Training and Neuromuscular Electrical Stimulation in Patients With Chronic Obstructive Pulmonary Disease

Universidade Federal de Santa Maria1 site in 1 country40 target enrollmentOctober 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Obstructive Pulmonary Disease
Sponsor
Universidade Federal de Santa Maria
Enrollment
40
Locations
1
Primary Endpoint
Static postural balance
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2019
End Date
March 10, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Isabella Martins de Albuquerque

Principal Investigator

Universidade Federal de Santa Maria

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;
  • Active smoker and/or alcoholic;

Outcomes

Primary Outcomes

Static postural balance

Time Frame: 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 Outcomes

  • Quadriceps femoris and diaphragm thickness(Post-intervention (change after 8 weeks of training))
  • Oxidant profile(Post-intervention (change after 8 weeks of training))
  • Balance confidence questionnaire(Post-intervention (change after 8 weeks of training))
  • Health-related quality of life at 8 week(Post-intervention (change after 8 weeks of training))
  • Antioxidant profile(Post-intervention (change after 8 weeks of training))
  • Static postural balance(Post-intervention (change after 8 weeks of training))
  • Dynamic postural balance(Post-intervention (change after 8 weeks of training))
  • Peripheral muscle strength(Post-intervention (change after 8 weeks of training))
  • Muscle damage(Post-intervention (change after 8 weeks of training))
  • Static and dynamic postural balance(Post-intervention (change after 8 weeks of training))
  • Respiratory muscle strength and inspiratory muscle endurance(Post-intervention (change after 8 weeks of training))
  • Submaximal level of functional capacity(Post-intervention (change after 8 weeks of training))
  • DNA damage(Post-intervention (change after 8 weeks of training))
  • Endothelial function(Post-intervention (change after 8 weeks of training))
  • Peripheral muscle resistance of the lower limbs(Post-intervention (change after 8 weeks of training))

Study Sites (1)

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