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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04117399
Other study ID # COPD-POSTURE
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date February 1, 2019
Est. completion date November 15, 2019

Study information

Verified date October 2019
Source Faculty of Medicine, Sousse
Contact n/a
Is FDA regulated No
Health authority
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. Risk of falls is multi-factorial and impaired balance has been shown to contribute.

The investigators aimed to demonstrate that, IMT performed during a PRP may improve Postural control in COPD patients.


Description:

Chronic obstructive pulmonary disease COPD is a preventable and treatable disease. According to the WHO, COPD would be the third leading cause of death by 2030. 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. However, emerging data showed that COPD patients demonstrate important deficits in balance and control which associated to a high risk of fall.

Individuals with COPD, especially those with inspiratory muscle weakness, increased their reliance on ankle muscle proprioceptive signals and decreased their reliance on back muscle proprioceptive signals during balance control, resulting in a decreased postural stability compared to healthy controls. These proprioceptive changes may be due to an impaired postural contribution of the inspiratory muscles to trunk stability.

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. However, the effect of inspiratory muscle training on postural control is not studying. The purpose of this study is to evaluate the effect of the inspiratory muscles training on posture in COPD patients.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 34
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)

- Lower limb injury

- Neurological injury or disease

- The absence of written informed consent

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Pulmonary rehabilitation
The experimental group receives inspiratory muscle training and aerobic exercise. The Active Comparator group received only aerobic exercise 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 (2)

Janssens L, Brumagne S, McConnell AK, Claeys K, Pijnenburg M, Burtin C, Janssens W, Decramer M, Troosters T. Proprioceptive changes impair balance control in individuals with chronic obstructive pulmonary disease. PLoS One. 2013;8(3):e57949. doi: 10.1371/journal.pone.0057949. Epub 2013 Mar 1. — View Citation

Smith MD, Chang AT, Seale HE, Walsh JR, Hodges PW. Balance is impaired in people with chronic obstructive pulmonary disease. Gait Posture. 2010 Apr;31(4):456-60. doi: 10.1016/j.gaitpost.2010.01.022. Epub 2010 Mar 4. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Balance outcomes Balance were measured by stabilometry to evaluate postural control in COPD patients. Two principals variabels were evaluated: the center of pressure in the mediolateral direction (CoP ML) ; the center of presure in anteroposterior direction (CoP AP). Basline, After 2 months
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