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

NCT04387318 | Completed DMC

• 1 other identifier: 08527219.0.0000.5346
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (4)

• Static postural balance

  Static postural balance will be assessed on a portable force platform (AccuSway Plus, AMTI®, MA, USA) using the center of pressure displacement amplitude in the anteroposterior direction (COP) (cm).

  Post-intervention (change after 8 weeks of training)

• Static postural balance

  Static postural balance will be assessed on a portable force platform (AccuSway Plus, AMTI®, MA, USA) using the area of ellipse (AE) (cm2).

  Post-intervention (change after 8 weeks of training)

• Static postural balance

  Static postural balance will be assessed on a portable force platform (AccuSway Plus, AMTI®, MA, USA) using the velocity of displacement of center of pressure (COPvel) (cm/s).

  Post-intervention (change after 8 weeks of training)

• Static postural balance

  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).

  Post-intervention (change after 8 weeks of training)

Secondary Outcomes (23)

• Static postural balance

  Post-intervention (change after 8 weeks of training)

• Static and dynamic postural balance

  Post-intervention (change after 8 weeks of training)

• Static and dynamic postural balance

  Post-intervention (change after 8 weeks of training)

• Dynamic postural balance

  Post-intervention (change after 8 weeks of training)

• Balance confidence questionnaire

  Post-intervention (change after 8 weeks of training)

Study Arms (4)

Multimodal training

EXPERIMENTAL

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.

Device: Multimodal training

IMT + Pulmonary Rehabilitation

EXPERIMENTAL

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.

Device: IMT + Pulmonary Rehabilitation

NMES + Pulmonary Rehabilitation

EXPERIMENTAL

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.

Device: NMES + Pulmonary Rehabilitation

Pulmonary Rehabilitation

PLACEBO COMPARATOR

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

Device: Pulmonary Rehabilitation

Interventions

Multimodal training DEVICE

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.

Multimodal training

IMT + Pulmonary Rehabilitation DEVICE

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.

IMT + Pulmonary Rehabilitation

NMES + Pulmonary Rehabilitation DEVICE

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.

NMES + Pulmonary Rehabilitation

Pulmonary Rehabilitation DEVICE

Pulmonary Rehabilitation The pulmonary rehabilitation will consist of aerobic and resistance exercise during 8 weeks.

Pulmonary Rehabilitation

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Federal de Santa Maria: lead

Study Sites (1)

Universidade Federal de Santa Maria

Santa Maria, Rio Grande do Sul, 97105900, Brazil

Location

Related Publications (1)

• Daros Dos Santos T, Pasqualoto AS, Cardoso DM, Da Cruz IBM, Moresco RN, Ferreira da Silveira A, Martins de Albuquerque I. Effects of multimodal exercise program on postural balance in patients with chronic obstructive pulmonary disease: study protocol for a randomized controlled trial. Trials. 2023 Aug 15;24(1):532. doi: 10.1186/s13063-023-07558-9.

  PMID: 37580800 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Isabella Albuquerque, DSc

  Universidade Federal de Santa Maria

  STUDY CHAIR

• Tamires dos Santos, MSc

  Universidade Federal de Santa Maria

  PRINCIPAL INVESTIGATOR

• Aron Silveira, DSc

  Universidade Federal de Santa Maria

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 1, 2020
• First Posted: May 13, 2020
• Study Start: October 1, 2019
• Primary Completion: March 10, 2023
• Study Completion: March 10, 2023
• Last Updated: May 31, 2023

Record last verified: 2023-05

Locations

BR (1)