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

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Multimodal training
IMT + Pulmonary Rehabilitation
NMES + Pulmonary Rehabilitation
Pulmonary Rehabilitation
Sponsored by
Universidade Federal de Santa Maria
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease

Eligibility Criteria

55 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Universidade Federal de Santa Maria

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Multimodal training

IMT + Pulmonary Rehabilitation

NMES + Pulmonary Rehabilitation

Pulmonary Rehabilitation

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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).
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).
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).
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).

Secondary Outcome Measures

Static postural balance
Static postural balance (%) will assessed through Foam-Laser dynamic posturography.
Static and dynamic postural balance
Static and dynamic postural balance will assessed using the Berg Balance Scale (score points). Scores range from 0 to 56, with higher scores indicating better balance.
Static and dynamic postural balance
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.
Dynamic postural balance
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.
Balance confidence questionnaire
Balance confidence questionnaire will measured through the Activities Specific Balance Confidence Scale (total score points). The questionnaire contains 16 items scored on a range from 0% to 100% (0 indicating no confidence and 100 indicating full confidence).
Balance confidence questionnaire
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).
Peripheral muscle strength
Handgrip strength and quadriceps muscle strength will be assessed by dynamometry, respectively, Kgf and Newtons.
Respiratory muscle strength and inspiratory muscle endurance
Respiratory muscle strength (cmH2O) and inspiratory muscle endurance (cmH2O) will measured through digital pressure manometry and incremental and constant test, respectively
Quadriceps femoris and diaphragm thickness
Quadriceps femoris and diaphragm thickness will measured by ultrasonography
Submaximal level of functional capacity
Submaximal level of functional capacity will measured by 6-minute walk test
Health-related quality of life at 8 week
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).
Oxidant profile
The oxidant profile will be assessed by Dichlorofluorescein Diacetate - DCF-DA (picomoles / mL).
Oxidant profile
The oxidant profile will be assessed by Thiobarbituric Acid Reactive Substances -TBARS (nmol de MDA/mL).
Oxidant profile
The oxidant profile will be assessed by Advanced Oxidation Protein Products - AOPPs (µmol/L).
Oxidant profile
The oxidant profile will be assessed by Total Oxidant Status - TOS (mmol Trolox Equiv/L).
Antioxidant profile
The antioxidant profile will be assessed by Ferric Reducing Antioxidant Power - FRAP- (µmol/L)
Antioxidant profile
The antioxidant profile will be assessed by Total Antioxidant Capacity- CAT (mmol Trolox Equiv/L).
Muscle damage
Muscle damage will assessed through creatine phosphokinase (total CPK) (U/L).
Muscle damage
Muscle damage will assessed through lactate dehydrogenase (LDH) (U/L).
Muscle damage
Muscle damage will assessed through lactate parameter (mg/dL).
DNA damage
DNA damage will assessed by means of the Comet and micronucleus assay
Endothelial function
Endothelial function will assessed through nitrite/nitrate oxide (NOx) (µmol/L)
Peripheral muscle resistance of the lower limbs
Peripheral muscle resistance of the lower limbs will assessed through 30-second Sit-to-Stand tests (repetitions)

Full Information

First Posted
May 1, 2020
Last Updated
May 28, 2023
Sponsor
Universidade Federal de Santa Maria
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1. Study Identification

Unique Protocol Identification Number
NCT04387318
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
March 10, 2023 (Actual)
Study Completion Date
March 10, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal de Santa Maria

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Multimodal training
Arm Type
Experimental
Arm Description
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.
Arm Title
IMT + Pulmonary Rehabilitation
Arm Type
Experimental
Arm Description
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.
Arm Title
NMES + Pulmonary Rehabilitation
Arm Type
Experimental
Arm Description
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.
Arm Title
Pulmonary Rehabilitation
Arm Type
Placebo Comparator
Arm Description
Pulmonary Rehabilitation: The physical training part of pulmonary rehabilitation will consist of aerobic and resistance exercise.
Intervention Type
Device
Intervention Name(s)
Multimodal training
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
IMT + Pulmonary Rehabilitation
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
NMES + Pulmonary Rehabilitation
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Pulmonary Rehabilitation
Intervention Description
Pulmonary Rehabilitation The pulmonary rehabilitation will consist of aerobic and resistance exercise during 8 weeks.
Primary Outcome Measure Information:
Title
Static postural balance
Description
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).
Time Frame
Post-intervention (change after 8 weeks of training)
Title
Static postural balance
Description
Static postural balance will be assessed on a portable force platform (AccuSway Plus, AMTI®, MA, USA) using the area of ellipse (AE) (cm2).
Time Frame
Post-intervention (change after 8 weeks of training)
Title
Static postural balance
Description
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).
Time Frame
Post-intervention (change after 8 weeks of training)
Title
Static postural balance
Description
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).
Time Frame
Post-intervention (change after 8 weeks of training)
Secondary Outcome Measure Information:
Title
Static postural balance
Description
Static postural balance (%) will assessed through Foam-Laser dynamic posturography.
Time Frame
Post-intervention (change after 8 weeks of training)
Title
Static and dynamic postural balance
Description
Static and dynamic postural balance will assessed using the Berg Balance Scale (score points). Scores range from 0 to 56, with higher scores indicating better balance.
Time Frame
Post-intervention (change after 8 weeks of training)
Title
Static and dynamic postural balance
Description
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.
Time Frame
Post-intervention (change after 8 weeks of training)
Title
Dynamic postural balance
Description
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.
Time Frame
Post-intervention (change after 8 weeks of training)
Title
Balance confidence questionnaire
Description
Balance confidence questionnaire will measured through the Activities Specific Balance Confidence Scale (total score points). The questionnaire contains 16 items scored on a range from 0% to 100% (0 indicating no confidence and 100 indicating full confidence).
Time Frame
Post-intervention (change after 8 weeks of training)
Title
Balance confidence questionnaire
Description
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).
Time Frame
Post-intervention (change after 8 weeks of training)
Title
Peripheral muscle strength
Description
Handgrip strength and quadriceps muscle strength will be assessed by dynamometry, respectively, Kgf and Newtons.
Time Frame
Post-intervention (change after 8 weeks of training)
Title
Respiratory muscle strength and inspiratory muscle endurance
Description
Respiratory muscle strength (cmH2O) and inspiratory muscle endurance (cmH2O) will measured through digital pressure manometry and incremental and constant test, respectively
Time Frame
Post-intervention (change after 8 weeks of training)
Title
Quadriceps femoris and diaphragm thickness
Description
Quadriceps femoris and diaphragm thickness will measured by ultrasonography
Time Frame
Post-intervention (change after 8 weeks of training)
Title
Submaximal level of functional capacity
Description
Submaximal level of functional capacity will measured by 6-minute walk test
Time Frame
Post-intervention (change after 8 weeks of training)
Title
Health-related quality of life at 8 week
Description
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).
Time Frame
Post-intervention (change after 8 weeks of training)
Title
Oxidant profile
Description
The oxidant profile will be assessed by Dichlorofluorescein Diacetate - DCF-DA (picomoles / mL).
Time Frame
Post-intervention (change after 8 weeks of training)
Title
Oxidant profile
Description
The oxidant profile will be assessed by Thiobarbituric Acid Reactive Substances -TBARS (nmol de MDA/mL).
Time Frame
Post-intervention (change after 8 weeks of training)
Title
Oxidant profile
Description
The oxidant profile will be assessed by Advanced Oxidation Protein Products - AOPPs (µmol/L).
Time Frame
Post-intervention (change after 8 weeks of training)
Title
Oxidant profile
Description
The oxidant profile will be assessed by Total Oxidant Status - TOS (mmol Trolox Equiv/L).
Time Frame
Post-intervention (change after 8 weeks of training)
Title
Antioxidant profile
Description
The antioxidant profile will be assessed by Ferric Reducing Antioxidant Power - FRAP- (µmol/L)
Time Frame
Post-intervention (change after 8 weeks of training)
Title
Antioxidant profile
Description
The antioxidant profile will be assessed by Total Antioxidant Capacity- CAT (mmol Trolox Equiv/L).
Time Frame
Post-intervention (change after 8 weeks of training)
Title
Muscle damage
Description
Muscle damage will assessed through creatine phosphokinase (total CPK) (U/L).
Time Frame
Post-intervention (change after 8 weeks of training)
Title
Muscle damage
Description
Muscle damage will assessed through lactate dehydrogenase (LDH) (U/L).
Time Frame
Post-intervention (change after 8 weeks of training)
Title
Muscle damage
Description
Muscle damage will assessed through lactate parameter (mg/dL).
Time Frame
Post-intervention (change after 8 weeks of training)
Title
DNA damage
Description
DNA damage will assessed by means of the Comet and micronucleus assay
Time Frame
Post-intervention (change after 8 weeks of training)
Title
Endothelial function
Description
Endothelial function will assessed through nitrite/nitrate oxide (NOx) (µmol/L)
Time Frame
Post-intervention (change after 8 weeks of training)
Title
Peripheral muscle resistance of the lower limbs
Description
Peripheral muscle resistance of the lower limbs will assessed through 30-second Sit-to-Stand tests (repetitions)
Time Frame
Post-intervention (change after 8 weeks of training)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isabella Albuquerque, DSc
Organizational Affiliation
Universidade Federal de Santa Maria
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Tamires dos Santos, MSc
Organizational Affiliation
Universidade Federal de Santa Maria
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Aron Silveira, DSc
Organizational Affiliation
Universidade Federal de Santa Maria
Official's Role
Study Chair
Facility Information:
Facility Name
Universidade Federal de Santa Maria
City
Santa Maria
State/Province
Rio Grande Do Sul
ZIP/Postal Code
97105900
Country
Brazil

12. IPD Sharing Statement

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

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