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Completed

NCT Number: NCT04084405

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

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.

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Key information

Conditions

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

Age range

45 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Bilel TOUNSI

Sousse, 4002, Tunisia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pulmonary Rehabilitation

Other

The experimental group receives inspiratory muscle training and aerobic exercise. The Active Comparator group received only aerobic exercise.

Primary outcomes

  1. Inspiratory muscle strengh

    Time frame: Baseline, 2 months follow up

    The inspiratory muscle strengh were measured by pre and post maximal inspiratory preasure

  2. 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

  3. 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.

  4. 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

  5. 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

Secondary outcomes

  1. The six minutes walk test (6MWT)

    Time frame: Baseline, 2 months follow up

    The test provides estimate endurance and funcional performance of patients

Sponsors and collaborators

Lead sponsor

Faculty of Medicine, Sousse

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Sep 10, 2019
Registry last updated
Feb 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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