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Clinical Trials/NCT04084405
NCT04084405
Completed
Not Applicable

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

Faculty of Medicine, Sousse1 site in 1 country35 target enrollmentJanuary 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Obstructive Pulmonary Disease
Sponsor
Faculty of Medicine, Sousse
Enrollment
35
Locations
1
Primary Endpoint
Timed Up and Go (TUG)
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2019
End Date
November 15, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Sponsor
Faculty of Medicine, Sousse
Responsible Party
Principal Investigator
Principal Investigator

Bilel Tounsi

PhD student

Faculty of Medicine, Sousse

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

  • The six minutes walk test (6MWT)(Baseline, 2 months follow up)

Study Sites (1)

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