Clinical trial NCT04084405: Effect of Inspiratory Muscle Training During Pulmonary Rehabilitation on Balance in COPD Patients
Official title: Effect of Inspiratory Muscle Training on Balance During PR in Chronic Obstructive Pulmonary Disease Patients (COPD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
IMT
ABC
BBS
TUG
SLS
Lead sponsor: Faculty of Medicine, Sousse
Sponsor class: OTHER
First posted: 2019-09-10
Enrollment: 35
Sex: MALE
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Inspiratory muscle strengh
timeFrame: Baseline, 2 months follow up
measure: ACTIVITIES-SPECIFIC BALANCE CONFIDENCE test (ABC)
timeFrame: Baseline, 2 months follow up
measure: Berg Balance Scale (BBS)
timeFrame: Baseline, 2 months follow up
measure: Single Leg Stance (SLS)
timeFrame: Baseline, 2 months follow up
measure: Timed Up and Go (TUG)
timeFrame: Baseline, 2 months follow up
Secondary outcomes:
measure: The six minutes walk test (6MWT)
timeFrame: Baseline, 2 months follow up
Other outcomes:
Locations:
city: Sousse
country: Tunisia
facility: Bilel TOUNSI
Study officials:
References:
citation: 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.
citation: 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.