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

NCT ID: NCT04084405

Last Updated: 2020-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2019-11-15

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.

Conditions

Chronic Obstructive Pulmonary Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

IMT group

Inspiratory muscle training + aerobic exercice

Group Type: EXPERIMENTAL

Pulmonary rehabilitation

Intervention Type: OTHER

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

Control group

aerobic exercice

Group Type: ACTIVE_COMPARATOR

Pulmonary rehabilitation

Intervention Type: OTHER

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

Interventions

Pulmonary rehabilitation

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Faculty of Medicine, Sousse

OTHER

Sponsor Role: lead

Responsible Party

Bilel Tounsi

PhD student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Bilel TOUNSI

Sousse, , Tunisia

Countries

Tunisia

References

Crisan 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.

Reference Type: BACKGROUND

PMID: 25768731 (View on PubMed)

Tounsi B, Acheche A, Lelard T, Tabka Z, Trabelsi Y, Ahmaidi S. Effects of specific inspiratory muscle training combined with whole-body endurance training program on balance in COPD patients: Randomized controlled trial. PLoS One. 2021 Sep 23;16(9):e0257595. doi: 10.1371/journal.pone.0257595. eCollection 2021.

Reference Type: DERIVED

PMID: 34555068 (View on PubMed)

Other Identifiers

COPD-Balance

Identifier Type: -

Identifier Source: org_study_id