Chronic Obstructive Pulmonary DiseaseNCT04117399
Effect of Inspiratory Muscle Training on Posture in Chronic Obstructive Pulmonary Disease Patients
A study testing Pulmonary rehabilitation in people with Chronic Obstructive Pulmonary Disease, run by Faculty of Medicine, Sousse at 1 site in Tunisia.
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. Read more about this study
- Who is it for?
- Ages 45 to 75 years, men only
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Pulmonary rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTunisia
- Study dates
- 1 Feb 2019to 15 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Were COPD diagnosed by pulmonary function testing
- Clinically stable
- Abscence of other obstructive diseases
- Signed written consert
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Inspiratory Muscle Training on Posture in Chronic Obstructive Pulmonary Disease Patients (COPD)
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.
Read the 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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Pulmonary rehabilitation
- Keywords
- COPD, IMT, CoP ML, CoP AP, Posture
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary rehabilitationOther
The experimental group receives inspiratory muscle training and aerobic exercise. The Active Comparator group received only aerobic exercise group received only aerobic exercise.
| Study group | Role | What they receive |
|---|---|---|
| IMT group | Experimental | Inspiratory muscle training + aerobic exercice Receives: Other: Pulmonary rehabilitation |
| Control group | Active comparator | aerobic exercice Receives: Other: Pulmonary rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Basline, After 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2019
- Study start1 Feb 2019
- Primary completion15 Nov 2019 (estimated)
- Study completion15 Nov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faculty of Medicine, Sousse
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bilel Tounsi, Faculty of Medicine, Sousse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04117399
- Sponsor's protocol ID
- COPD-POSTURE
- Status last verified
- Oct 2019
- First submitted
- 28 Sep 2019
- Last updated
- 7 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 20206529Janssens 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.
PubMed 23469255
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Inspiratory Muscle Training on Posture in Chronic Obstructive Pulmonary Disease Patients (COPD)
- ClinicalTrials.gov ID
- NCT04117399
- Acronym / sponsor ID
- COPD-POSTURE
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, IMT, CoP ML, CoP AP, Posture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Faculty of Medicine, SousseUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 15 Nov 2019 (estimated)
- Study completion
- 15 Nov 2019 (estimated)
- First posted
- 7 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IMT group | Experimental | Other: Pulmonary rehabilitationInspiratory muscle training + aerobic exercice |
| Control group | Active comparator | Other: Pulmonary rehabilitationaerobic exercice |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Were COPD diagnosed by pulmonary function testing
- Clinically stable
- Abscence of other obstructive diseases
- Signed written consert
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulmonary rehabilitationThe experimental group receives inspiratory muscle training and aerobic exercise. The Active Comparator group received only aerobic exercise group received only aerobic exercise. | Other | Control group, IMT group |
Primary outcome
Balance outcomes
Time frame: Basline, After 2 months
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2019.
- Background: PubMed 20206529Smith 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.
- Background: PubMed 23469255Janssens 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulmonary rehabilitation in people with Chronic Obstructive Pulmonary Disease, run by Faculty of Medicine, Sousse at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Balance outcomes (time frame: Basline, After 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04117399, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2019; AzTrials last refreshed its copy on 6 Nov 2026.