Effect of Inspiratory Muscle Training During Pulmonary Rehabilitation on Balance in COPD Patients

Study Overview
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Brief Summary
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Chronic obstructive pulmonary disease (COPD) is a respiratory disease that results in progressive airflow limitation and respiratory distress. Physiopathological features of COPD suggest that people who suffer from this disease have many risk factors for falls that have been identified in older individuals. The benefit of inspiratory muscle training (IMT) combined with a pulmonary rehabilitation programme (PRP) is uncertain. The investigators aimed to demonstrate that,in chronic obstructive pulmonary disease (COPD) patients, IMT performed during a PRP is associated with an improvement of Balance.

Detailed Description
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Chronic obstructive pulmonary disease COPD is a preventable and treatable disease(GOLD, 2017). According to the WHO, COPD would be the third leading cause of death by 2030 (WHO, 2017). This disease is characterized by airflow limitation that is not fully reversible. The airflow limitation is usually progressive and associated with an abnormal inflammatory response of the lung to noxious particles or gases(GOLD, 2017). However, emerging data showed that COPD patients demonstrate important deficits in balance and control which associated to a high risk of fall ( Butcher et al, 2004 ; Smith et al, 2009 ; Beauchamp et al, 2009 ; Beauchamp et al, 2010). Inspiratory muscle training (IMT) has been shown to be an effective modality for COPD patients for improving the maximal inspiratory muscle strength, the dyspnea and health-related quality of life (GI COPD, 2016). However, the effect of inspiratory muscle training on balance is not studying. The purpose of this study is to evaluate the effect of the inspiratory muscles training on balance in COPD patients.

Official Title
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Effect of Inspiratory Muscle Training on Balance During PR in Chronic Obstructive Pulmonary Disease Patients (COPD)

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Other: Pulmonary rehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Were COPD diagnosed by pulmonary function testing clinically stable abscence of other obstructive diseases signed written consert. Exclusion Criteria: Were previous pneumonectomy or lobectomy in the past 6 months spontaneous risk of pneumothorax or rib fracture incapacity to follow a standard rehabilitation programme (locomotor deficits, acute cardiac failure and acute exacerbation of COPD at the beginning of the programme) the absence of written informed consent.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IMT group<br>Inspiratory muscle training + aerobic exercice | Other: Pulmonary rehabilitation<br>* The experimental group receives inspiratory muscle training and aerobic exercise. The Active Comparator group received only aerobic exercise.<br>|
| Active Comparator: Control group<br>aerobic exercice | Other: Pulmonary rehabilitation<br>* The experimental group receives inspiratory muscle training and aerobic exercise. The Active Comparator group received only aerobic exercise.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inspiratory muscle strengh | The inspiratory muscle strengh were measured by pre and post maximal inspiratory preasure | Baseline, 2 months follow up | 
| ACTIVITIES-SPECIFIC BALANCE CONFIDENCE test (ABC) | The ABC scale requires patients to indicate their confidence in performing 16 activities without losing their balance or becoming unsteady on an 11-point scale (0%-100%).Higher scores indicates higher balance confidence and lower scores indicates poor balance confidence | Baseline, 2 months follow up | 
| Berg Balance Scale (BBS) | The patients were evaluated by The test BBS. The score obtained from 0 to 56.Higher scores indicate better balance. | Baseline, 2 months follow up | 
| Single Leg Stance (SLS) | Patients selected the leg on which they they preferred to stand for the test. They were instructed to keep their legs from touching and to maintain a unipedal stance for as long as possible | Baseline, 2 months follow up | 
| Timed Up and Go (TUG) | The test requires the patient to rise from a standard armchair, walk 3 m at a comfortable pace, walk back to the chair, and sit down | Baseline, 2 months follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The six minutes walk test (6MWT) | The test provides estimate endurance and funcional performance of patients | Baseline, 2 months follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, IMT, ABC, BBS, TUG, SLS