Effect of Inspiratory Muscle Training on Balance in Chronic Obstructive Pulmonary Disease Patients

Overview

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.

Full Title of Study: “Effect of Inspiratory Muscle Training on Balance in Chronic Obstructive Pulmonary Disease Patients (COPD)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Single (Care Provider)
  • Study Primary Completion Date: November 15, 2019

Detailed Description

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.

Interventions

  • Other: Pulmonary rehabilitation
    • The experimental group receives inspiratory muscle training and aerobic exercise. The Active Comparator group received only aerobic exercise.

Arms, Groups and Cohorts

  • Experimental: IMT group
    • Inspiratory muscle training + aerobic exercice
  • Active Comparator: Control group
    • aerobic exercice

Clinical Trial Outcome Measures

Primary Measures

  • Inspiratory muscle strengh
    • Time Frame: Baseline, 2 months follow up
    • The inspiratory muscle strengh were measured by pre and post maximal inspiratory preasure
  • ACTIVITIES-SPECIFIC BALANCE CONFIDENCE test (ABC)
    • Time Frame: Baseline, 2 months follow up
    • 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
  • Berg Balance Scale (BBS)
    • Time Frame: Baseline, 2 months follow up
    • The patients were evaluated by The test BBS. The score obtained from 0 to 56.Higher scores indicate better balance.
  • Single Leg Stance (SLS)
    • Time Frame: Baseline, 2 months follow up
    • 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
  • Timed Up and Go (TUG)
    • Time Frame: Baseline, 2 months follow up
    • 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

Participating in This Clinical Trial

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.

Gender Eligibility: Male

Minimum Age: 45 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Faculty of Medicine, Sousse
  • Provider of Information About this Clinical Study
    • Principal Investigator: Bilel Tounsi, PhD student – Faculty of Medicine, Sousse

References

Cri┼čan AF, Oancea C, Timar B, Fira-Mladinescu O, Tudorache V. Balance impairment in patients with COPD. PLoS One. 2015 Mar 13;10(3):e0120573. doi: 10.1371/journal.pone.0120573. eCollection 2015.

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