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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04084405
• Other study ID #: COPD-Balance
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: November 15, 2019

Study information

• Verified date: January 2020
• Source: Faculty of Medicine, Sousse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: November 15, 2019
• Est. primary completion date: November 15, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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

Locations

Country	Name	City	State
Tunisia	Bilel TOUNSI	Sousse

Sponsors (1)

Lead Sponsor	Collaborator
Faculty of Medicine, Sousse

Country where clinical trial is conducted

Tunisia, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inspiratory muscle strengh	The inspiratory muscle strengh were measured by pre and post maximal inspiratory preasure	Baseline, 2 months follow up
Primary	ACTIVITIES-SPECIFIC BALANCE CONFIDENCE test (ABC)	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	Baseline, 2 months follow up
Primary	Berg Balance Scale (BBS)	The patients were evaluated by The test BBS. The score obtained from 0 to 56.Higher scores indicate better balance.	Baseline, 2 months follow up
Primary	Single Leg Stance (SLS)	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	Baseline, 2 months follow up
Primary	Timed Up and Go (TUG)	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	Baseline, 2 months follow up
Secondary	The six minutes walk test (6MWT)	The test provides estimate endurance and funcional performance of patients	Baseline, 2 months follow up