Clinical trial NCT04655534: 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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
COPD
Keywords: inspiratory muscle warm-up
inspiratory muscle training
lung functions
respiratory functions
respiratory muscle strength
exercise capacity
dyspnea
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
First posted: 2020-12-07
Enrollment: 30
Sex: ALL
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Respiratory functions
timeFrame: 8 weeks
measure: Inspiratory muscle strength
timeFrame: 8 weeks
measure: Expiratory muscle strength
timeFrame: 8 weeks
measure: Dyspnea assessment
timeFrame: 8 weeks
measure: Exercise capacity assessment
timeFrame: 8 weeks
Secondary outcomes:
measure: Health-Related Quality of Life (HRQOL) using the 36-item Short Form Survey (SF-36)
timeFrame: 8 weeks
measure: Health-Related Quality of Life assessment using the St. George's Respiratory Questionnaire (SGRQ)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Dokuz Eylul University
state: Balçova
Study officials:
affiliation: Dokuz Eylul University
name: Sevgi Ozalevli, PT, Prof
role: STUDY_DIRECTOR
affiliation: Dokuz Eylul University
name: Ridvan Aktan, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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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.
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.
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.
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.