Chronic Obstructive Pulmonary DiseaseNCT04084405
Effect of Inspiratory Muscle Training During Pulmonary Rehabilitation on Balance in COPD 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
- 35 participants
- Where
- 1 siteTunisia
- Study dates
- 1 Jan 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)
- 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 Balance During PR 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.
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.
Read the 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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Pulmonary rehabilitation
- Keywords
- COPD, IMT, ABC, BBS, TUG, SLS
- 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.
| 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.
Inspiratory muscle strengh
The inspiratory muscle strengh were measured by pre and post maximal inspiratory preasure
Measured: Baseline, 2 months follow up
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
Measured: Baseline, 2 months follow up
Berg Balance Scale (BBS)
The patients were evaluated by The test BBS. The score obtained from 0 to 56.Higher scores indicate better balance.
Measured: Baseline, 2 months follow up
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
Measured: Baseline, 2 months follow up
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
Measured: Baseline, 2 months follow up
Secondary outcomes (1)
The six minutes walk test (6MWT)
The test provides estimate endurance and funcional performance of patients
Measured: Baseline, 2 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2019
- Study start1 Jan 2019
- Primary completion15 Nov 2019
- Study completion15 Nov 2019
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
- 35 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
- NCT04084405
- Sponsor's protocol ID
- COPD-Balance
- Status last verified
- Jan 2020
- First submitted
- 5 Sep 2019
- Last updated
- 5 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25768731Tounsi 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.
PubMed 34555068
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Inspiratory Muscle Training on Balance During PR in Chronic Obstructive Pulmonary Disease Patients (COPD)
- ClinicalTrials.gov ID
- NCT04084405
- Acronym / sponsor ID
- COPD-Balance
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, IMT, ABC, BBS, TUG, SLS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Faculty of Medicine, SousseUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 15 Nov 2019 (actual)
- Study completion
- 15 Nov 2019 (actual)
- First posted
- 10 Sep 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.
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.
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 (4 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)
- the absence of written informed consent.
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. | Other | Control group, IMT group |
Primary outcome
Inspiratory muscle strengh
Time frame: Baseline, 2 months follow up
The inspiratory muscle strengh were measured by pre and post maximal inspiratory preasure
ACTIVITIES-SPECIFIC BALANCE CONFIDENCE test (ABC)
Time frame: Baseline, 2 months follow up
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
Berg Balance Scale (BBS)
Time frame: Baseline, 2 months follow up
The patients were evaluated by The test BBS. The score obtained from 0 to 56.Higher scores indicate better balance.
Single Leg Stance (SLS)
Time frame: Baseline, 2 months follow up
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
Timed Up and Go (TUG)
Time frame: Baseline, 2 months follow up
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
1 secondary outcome
The six minutes walk test (6MWT)
Time frame: Baseline, 2 months follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
- Background: PubMed 25768731Crisan 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.
- Derived from this study: PubMed 34555068Tounsi 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.
- 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 4 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: finished, as of the sponsor's last update on 5 Feb 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Inspiratory muscle strengh (time frame: Baseline, 2 months follow up). The study lists 5 primary outcomes in all. 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 NCT04084405, 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 5 Feb 2020.