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

NCT04655534 | Completed

• 1 other identifier: RidvanAKTAN_2018.KB.SAG.026
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease; COPD

Keywords

inspiratory muscle warm-up; inspiratory muscle training; lung functions; respiratory functions; respiratory muscle strength; exercise capacity; dyspnea

Outcome Measures

Primary Outcomes (5)

• 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.

  8 weeks

• 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.

  8 weeks

• 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.

  8 weeks

• 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.

  8 weeks

• Exercise capacity assessment

  The 6-Minute Walking Test distance (6MWD) was used to assess exercise capacity.

  8 weeks

Secondary Outcomes (2)

• Health-Related Quality of Life (HRQOL) using the 36-item Short Form Survey (SF-36)

  8 weeks

• Health-Related Quality of Life assessment using the St. George's Respiratory Questionnaire (SGRQ)

  8 weeks

Study Arms (2)

IMW Group

EXPERIMENTAL

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

Other: Inspiratory Muscle Warm-up (IMW); Other: Inspiratory Muscle Training (IMT); Other: Respiratory exercises and aerobic exercise program

Standart IMT Group

EXPERIMENTAL

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

Other: Inspiratory Muscle Training (IMT); Other: Respiratory exercises and aerobic exercise program

Interventions

Inspiratory Muscle Warm-up (IMW) OTHER

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.

IMW Group

Inspiratory Muscle Training (IMT) OTHER

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.

IMW Group; Standart IMT Group

Respiratory exercises and aerobic exercise program OTHER

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.

IMW Group; Standart IMT Group

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Dokuz Eylul University: lead

Study Sites (1)

Dokuz Eylul University

Izmir, Balçova, 35330, Turkey (Türkiye)

Location

Related Publications (6)

• 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.

  PMID: 28385046 BACKGROUND

• 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.

  PMID: 11445767 BACKGROUND

• 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.

  PMID: 17234806 BACKGROUND

• 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.

  PMID: 26903486 BACKGROUND

• 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.

  PMID: 11223726 BACKGROUND

• 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.

  PMID: 21347970 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Dyspnea

Condition Hierarchy (Ancestors)

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

Study Officials

• Sevgi Ozalevli, PT, Prof

  Dokuz Eylul University

  STUDY DIRECTOR

• Ridvan Aktan, PT, PhD

  Dokuz Eylul University

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: 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.

Study Record Dates

• First Submitted: November 30, 2020
• First Posted: December 7, 2020
• Study Start: June 1, 2019
• Primary Completion: February 1, 2020
• Study Completion: December 28, 2020
• Last Updated: January 5, 2021

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)