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The Effect of Inspiratory Muscle Warm-Up in Patients With COPD

Primary Purpose

Chronic Obstructive Pulmonary Disease, COPD

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Inspiratory Muscle Warm-up (IMW)
Inspiratory Muscle Training (IMT)
Respiratory exercises and aerobic exercise program
Sponsored by
Dokuz Eylul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring inspiratory muscle warm-up, inspiratory muscle training, lung functions, respiratory functions, respiratory muscle strength, exercise capacity, dyspnea

Eligibility Criteria

45 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosing COPD in accordance with Global initiative for chronic obstructive pulmonary disease (GOLD) guideline criteria
  • Having a Maximal inspiratory pressure (MIP) less than 60 cmH2O
  • Aged between 45 and 70 years
  • Independent mobilization
  • Volunteering to research
  • Stable clinical condition (same medication routine without taking any antibiotics for the last 3 weeks and/or no acute exacerbation in the last 3 months)

Exclusion Criteria:

  • Not quitting smoking
  • A previous pneumonectomy or lobectomy operation.
  • Pneumonia in the last 3 months.
  • Any pulmonary infection during the study.
  • Requirement for supplemental oxygen therapy
  • Orthopaedic or neurological conditions effecting the ability to exercise

Sites / Locations

  • Dokuz Eylul University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

IMW Group

Standart IMT Group

Arm Description

Patients who performed inspiratory muscle warm-up (IMW) before inspiratory muscle training (IMT)

Patients who performed standard inspiratory muscle training (IMT) without inspiratory muscle warm-up (IMW) protocol

Outcomes

Primary Outcome Measures

Respiratory functions
Respiratory functions were evaluated by pulmonary function tests. Pulmonary function tests were performed in accordance with the American Thoracic Society (ATS) / European Respiratory Society (ERS) criteria, in a sitting position with a computer-compatible spirometer (Sensor Medics Vmax 22 machine, SensorMedics Inc., Anaheim, CA). Percentages of forced expiratory volume in one second (FEV1), forced vital capacity (FVC) and FEV1 / FVC ratio values relative to the predicted value were recorded in pulmonary function tests.
Inspiratory muscle strength
Inspiratory muscle strength (MIP) was measured using a hand-held mouth pressure device (Micro RMP; Micro Medical, Rochester, UK). Three to five acceptable and reproducible maximal manoeuvres (i.e., differences between values <10%) were performed and the highest value was recorded.
Expiratory muscle strength
Expiratory muscle strength (MEP) was measured using a hand-held mouth pressure device (Micro RMP; Micro Medical, Rochester, UK). Three to five acceptable and reproducible maximal manoeuvres (i.e., differences between values <10%) were performed and the highest value was recorded.
Dyspnea assessment
The modified Medical Research Council (mMRC) Dyspnea Scale was used to evaluate the severity of dyspnea. Commonly used in the assessment of dyspnea in COPD, mMRC has a five-level scoring system ranging from 0 to 4. A high score indicates an increased sense of dyspnea.
Exercise capacity assessment
The 6-Minute Walking Test distance (6MWD) was used to assess exercise capacity.

Secondary Outcome Measures

Health-Related Quality of Life (HRQOL) using the 36-item Short Form Survey (SF-36)
The SF-36 is a general quality of life survey which includes 36 items and enables the measurement of eight sections; physical functioning, social role functioning, physical role functioning, emotional role functioning, mental health, vitality, bodily pain and general health perceptions. Each category is scored from 0 to 100. Lower scores indicating worse HRQOL.
Health-Related Quality of Life assessment using the St. George's Respiratory Questionnaire (SGRQ)
The SGRQ is a specific questionnaire for respiratory diseases. It is a self-administered questionnaire by patients which questioned 50 items with 76 weighted responses divided into three areas: symptoms (8 items), activities (16 items), effects of the disease (26 items). The three parts of the questionnaire are scored separately and the total score is calculated. Scores range from 0-100. Higher scores indicating worse HRQOL.

Full Information

First Posted
November 30, 2020
Last Updated
December 31, 2020
Sponsor
Dokuz Eylul University
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1. Study Identification

Unique Protocol Identification Number
NCT04655534
Brief Title
The Effect of Inspiratory Muscle Warm-Up in Patients With COPD
Official Title
The Effect of Inspiratory Muscle Warm-Up Prior to Inspiratory Muscle Training in Addition to Exercise Training in Patients With COPD
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
February 1, 2020 (Actual)
Study Completion Date
December 28, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dokuz Eylul University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
In this study, it is aimed to investigate the effect of inspiratory muscle warm-up (IMW) performed before inspiratory muscle training (IMT) in addition to general exercise training on respiratory functions, respiratory muscle strength, exercise capacity, perceived dyspnea intensity and health-related quality of life in patients with COPD.
Detailed Description
Chronic obstructive pulmonary disease (COPD) is a disease that leads to increased morbidity and mortality with severe pulmonary complications. The Global Burden of Disease studies have estimated that COPD is the third leading cause of death worldwide. The effects of COPD are not only limited to the lungs but also affects other organs and systems, causing loss of strength in the respiratory and peripheral muscles, which leading to a decreased capacity for exercise. Respiratory muscles are the skeletal muscles that can be trained based on the principles of exercise just like peripheral muscles. It is known that while doing exercise training in peripheral muscles, more muscle performance can be achieved by warming up those muscles before the loading phase. In this study, it is aimed to investigate the effect of inspiratory muscle warm-up (IMW) performed before inspiratory muscle training (IMT) in addition to general exercise training on respiratory functions, respiratory muscle strength, exercise capacity, perceived dyspnea intensity and health-related quality of life in patients with COPD. Participants were randomly divided into two groups as the study group (IMW Group) and the control group (Standard IMT Group). The Standard IMT Group performed only IMT, while the IMW Group performed an IMW protocol for warming the inspiratory muscles before each IMT session. The IMT and IMW were applied using a threshold pressure loading device. The IMT applied as 30 breath repetitions at 60% of the maximal inspiratory pressure (MIP). The intensity of MIP adjusts by two weekly MIP measurements. The protocol of IMW consists of 2 sets of 30 breaths at 40% of MIP, with 1 min rest between sets, using a threshold inspiratory muscle trainer. Then the respiratory exercises and aerobic exercise program performed in both groups in each session. Aerobic exercise program; After 5 min of general body warming, applied 20 min with a load of 4-6 according to the modified Borg scale on the treadmill, finished with 5 min whole body cool-down. All program applied to 3 days a week for 8 weeks under the supervision of a physiotherapist and other days of the week without a supervisor. Demographic features questioned and recorded in the data recording form through a mutual interview in patients who meet the inclusion criteria. All patients evaluated before treatment and after treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease, COPD
Keywords
inspiratory muscle warm-up, inspiratory muscle training, lung functions, respiratory functions, respiratory muscle strength, exercise capacity, dyspnea

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This study was designed as a prospective and experimental study. Participants were randomly divided into two groups as the study group (IMW Group) and the control group (Standard IMT Group). The Standard IMT Group performed only inspiratory muscle training (IMT), while the IMW Group performed an inspiratory muscle warm-up (IMW) protocol for warming the inspiratory muscles before each IMT session. The IMT and IMW applied using a threshold pressure loading device.
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IMW Group
Arm Type
Experimental
Arm Description
Patients who performed inspiratory muscle warm-up (IMW) before inspiratory muscle training (IMT)
Arm Title
Standart IMT Group
Arm Type
Experimental
Arm Description
Patients who performed standard inspiratory muscle training (IMT) without inspiratory muscle warm-up (IMW) protocol
Intervention Type
Other
Intervention Name(s)
Inspiratory Muscle Warm-up (IMW)
Intervention Description
The IMW protocol applied before each inspiratory muscle training (IMT) session by using a threshold inspiratory muscle trainer. The IMW protocol consists of 2 sets of 30 breaths in 40% of the maximal inspiratory pressure (MIP), with 1 min rest between sets. The intensity of MIP adjusted by two weekly MIP measurements.
Intervention Type
Other
Intervention Name(s)
Inspiratory Muscle Training (IMT)
Intervention Description
The IMT applied twice a day as 30 breath repetitions at 60% of the maximal inspiratory pressure (MIP). The intensity of MIP adjusted by two weekly MIP measurements.
Intervention Type
Other
Intervention Name(s)
Respiratory exercises and aerobic exercise program
Intervention Description
Then the respiratory exercises and aerobic exercise program performed in both groups in each session. Aerobic exercise program; After 5 min of general body warming, applied 20 min with a load of 4-6 according to the modified Borg scale on the treadmill, finished with 5 min whole body cool-down. All program applied to 3 days a week for 8 weeks under the supervision of a physiotherapist and other days of the week without a supervisor.
Primary Outcome Measure Information:
Title
Respiratory functions
Description
Respiratory functions were evaluated by pulmonary function tests. Pulmonary function tests were performed in accordance with the American Thoracic Society (ATS) / European Respiratory Society (ERS) criteria, in a sitting position with a computer-compatible spirometer (Sensor Medics Vmax 22 machine, SensorMedics Inc., Anaheim, CA). Percentages of forced expiratory volume in one second (FEV1), forced vital capacity (FVC) and FEV1 / FVC ratio values relative to the predicted value were recorded in pulmonary function tests.
Time Frame
8 weeks
Title
Inspiratory muscle strength
Description
Inspiratory muscle strength (MIP) was measured using a hand-held mouth pressure device (Micro RMP; Micro Medical, Rochester, UK). Three to five acceptable and reproducible maximal manoeuvres (i.e., differences between values <10%) were performed and the highest value was recorded.
Time Frame
8 weeks
Title
Expiratory muscle strength
Description
Expiratory muscle strength (MEP) was measured using a hand-held mouth pressure device (Micro RMP; Micro Medical, Rochester, UK). Three to five acceptable and reproducible maximal manoeuvres (i.e., differences between values <10%) were performed and the highest value was recorded.
Time Frame
8 weeks
Title
Dyspnea assessment
Description
The modified Medical Research Council (mMRC) Dyspnea Scale was used to evaluate the severity of dyspnea. Commonly used in the assessment of dyspnea in COPD, mMRC has a five-level scoring system ranging from 0 to 4. A high score indicates an increased sense of dyspnea.
Time Frame
8 weeks
Title
Exercise capacity assessment
Description
The 6-Minute Walking Test distance (6MWD) was used to assess exercise capacity.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Health-Related Quality of Life (HRQOL) using the 36-item Short Form Survey (SF-36)
Description
The SF-36 is a general quality of life survey which includes 36 items and enables the measurement of eight sections; physical functioning, social role functioning, physical role functioning, emotional role functioning, mental health, vitality, bodily pain and general health perceptions. Each category is scored from 0 to 100. Lower scores indicating worse HRQOL.
Time Frame
8 weeks
Title
Health-Related Quality of Life assessment using the St. George's Respiratory Questionnaire (SGRQ)
Description
The SGRQ is a specific questionnaire for respiratory diseases. It is a self-administered questionnaire by patients which questioned 50 items with 76 weighted responses divided into three areas: symptoms (8 items), activities (16 items), effects of the disease (26 items). The three parts of the questionnaire are scored separately and the total score is calculated. Scores range from 0-100. Higher scores indicating worse HRQOL.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosing COPD in accordance with Global initiative for chronic obstructive pulmonary disease (GOLD) guideline criteria Having a Maximal inspiratory pressure (MIP) less than 60 cmH2O Aged between 45 and 70 years Independent mobilization Volunteering to research Stable clinical condition (same medication routine without taking any antibiotics for the last 3 weeks and/or no acute exacerbation in the last 3 months) Exclusion Criteria: Not quitting smoking A previous pneumonectomy or lobectomy operation. Pneumonia in the last 3 months. Any pulmonary infection during the study. Requirement for supplemental oxygen therapy Orthopaedic or neurological conditions effecting the ability to exercise
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sevgi Ozalevli, PT, Prof
Organizational Affiliation
Dokuz Eylul University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ridvan Aktan, PT, PhD
Organizational Affiliation
Dokuz Eylul University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dokuz Eylul University
City
İzmir
State/Province
Balçova
ZIP/Postal Code
35330
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28385046
Citation
Bisca GW, Camillo CA, Cavalheri V, Pitta F, Osadnik CR. Peripheral muscle training in patients with chronic obstructive pulmonary disease: novel approaches and recent advances. Expert Rev Respir Med. 2017 May;11(5):413-423. doi: 10.1080/17476348.2017.1317598. Epub 2017 Apr 17.
Results Reference
background
PubMed Identifier
11445767
Citation
Volianitis S, McConnell AK, Koutedakis Y, Jones DA. Specific respiratory warm-up improves rowing performance and exertional dyspnea. Med Sci Sports Exerc. 2001 Jul;33(7):1189-93. doi: 10.1097/00005768-200107000-00017.
Results Reference
background
PubMed Identifier
17234806
Citation
Ross EZ, Nowicky AV, McConnell AK. Influence of acute inspiratory loading upon diaphragm motor-evoked potentials in healthy humans. J Appl Physiol (1985). 2007 May;102(5):1883-90. doi: 10.1152/japplphysiol.00694.2006. Epub 2007 Jan 18.
Results Reference
background
PubMed Identifier
26903486
Citation
Ozdal M. Acute effects of inspiratory muscle warm-up on pulmonary function in healthy subjects. Respir Physiol Neurobiol. 2016 Jun 15;227:23-6. doi: 10.1016/j.resp.2016.02.006. Epub 2016 Feb 21.
Results Reference
background
PubMed Identifier
11223726
Citation
Volianitis S, McConnell AK, Jones DA. Assessment of maximum inspiratory pressure. Prior submaximal respiratory muscle activity ('warm-up') enhances maximum inspiratory activity and attenuates the learning effect of repeated measurement. Respiration. 2001;68(1):22-7. doi: 10.1159/000050458.
Results Reference
background
PubMed Identifier
21347970
Citation
Lomax M, Grant I, Corbett J. Inspiratory muscle warm-up and inspiratory muscle training: separate and combined effects on intermittent running to exhaustion. J Sports Sci. 2011 Mar;29(6):563-9. doi: 10.1080/02640414.2010.543911.
Results Reference
background

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The Effect of Inspiratory Muscle Warm-Up in Patients With COPD

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