Effect of Inspiratory Muscle Training on Posture in Chronic Obstructive Pulmonary Disease Patients
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Unknown status
Phase
Not Applicable
Locations
Tunisia
Study Type
Interventional
Intervention
Pulmonary rehabilitation
Sponsored by
About this trial
This is an interventional supportive care trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD, IMT, CoP ML, CoP AP, Posture
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)
- Lower limb injury
- Neurological injury or disease
- The absence of written informed consent
Sites / Locations
- Bilel TOUNSI
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
IMT group
Control group
Arm Description
Inspiratory muscle training + aerobic exercice
aerobic exercice
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT04117399
First Posted
September 28, 2019
Last Updated
October 3, 2019
Sponsor
Faculty of Medicine, Sousse
1. Study Identification
Unique Protocol Identification Number
NCT04117399
Brief Title
Effect of Inspiratory Muscle Training on Posture in Chronic Obstructive Pulmonary Disease Patients
Official Title
Effect of Inspiratory Muscle Training on Posture in Chronic Obstructive Pulmonary Disease Patients (COPD)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
November 15, 2019 (Anticipated)
Study Completion Date
November 15, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Faculty of Medicine, Sousse
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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. 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
COPD, IMT, CoP ML, CoP AP, Posture
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IMT group
Arm Type
Experimental
Arm Description
Inspiratory muscle training + aerobic exercice
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
aerobic exercice
Intervention Type
Other
Intervention Name(s)
Pulmonary rehabilitation
Intervention Description
The experimental group receives inspiratory muscle training and aerobic exercise. The Active Comparator group received only aerobic exercise group received only aerobic exercise.
Primary Outcome Measure Information:
Title
Balance outcomes
Description
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).
Time Frame
Basline, After 2 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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)
Lower limb injury
Neurological injury or disease
The absence of written informed consent
Facility Information:
Facility Name
Bilel TOUNSI
City
Sousse
ZIP/Postal Code
4002
Country
Tunisia
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
20206529
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.
Results Reference
background
PubMed Identifier
23469255
Citation
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.
Results Reference
background
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Effect of Inspiratory Muscle Training on Posture in Chronic Obstructive Pulmonary Disease Patients
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