Chronic Obstructive Pulmonary DiseaseNCT02257463
Effect of Inspiratory Muscle Training on Exercise Performance and Quality of Life in Patients With Chronic Obstructive Pulmonary Disease
A study testing theophylline, long acting bronchodilators (LABD) or combined LABD and inhaled steroids according to GOLD recommendations, peripheral muscles exercise training and inspiratory muscle training in people with Chronic Obstructive Pulmonary Disease, run by Mansoura University.
Trial summary
The aim is to study effectiveness of inspiratory muscle training as a part of exercise training in patients with Chronic Obstructive Pulmonary Disease (COPD) and if it adds to general exercise training program in regard to respiratory muscle strength, dyspnea, exercise performance and quality of life. Read more about this study
- Who is it for?
- Ages 45 to 65 years, men only
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- theophylline, long acting bronchodilators (LABD) or combined LABD and inhaled steroids according to GOLD recommendations, peripheral muscles exercise training and inspiratory muscle training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Oct 2011to Apr 2014
- 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 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Exsmokers
- Low PImax compared to reference values [lower limits of normal: 80 cmH2O for patients less than or equal 54 years old; 71 cmH2O for patients' age between 55-64 years; and 65 cmH2O for patients 65 years old ].
- Stable patients without history of exacerbation or hospitalization four weeks before starting the study.
Who cannot join
- Lack of motivation and compliance.
- Patients with significant reversibility following bronchodilation defined as an increase in FEV1 of more than 12% and 200 ml from the pre-bronchodilator value
- Unstable cardiac disease [severe heart failure, dangerous dysrhythmias, recent myocardial infarction or unstable angina (within 4 weeks)].
- Uncontrolled hypertension
- Recent pneumothorax (within 6 weeks)
- Recent abdominal or thoracic surgery (within 6 weeks)
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- Known progressive neuromuscular disorders
- Recent gastrointestinal bleeding (within 4 weeks)
- Current smokers
- Active cancer
- Patients with advanced liver diseases, or renal impairment.
- Known connective tissue diseases
- Significant endocrinal abnormalities
About this study
The aim is to study effectiveness of inspiratory muscle training as a part of exercise training in patients with Chronic Obstructive Pulmonary Disease (COPD) and if it adds to general exercise training program in regard to respiratory muscle strength, dyspnea, exercise performance and quality of life.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- theophylline, long acting bronchodilators (LABD) or combined LABD and inhaled steroids according to GOLD recommendations, peripheral muscles exercise training, inspiratory muscle training
- Keywords
- COPD, inspiratory muscle training, dyspnea, Quality of Life
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
theophylline, long acting bronchodilators (LABD) or combined LABD and inhaled steroids according to GOLD recommendationsDrug
Also called uniphyllin, foradil, spiriva, miflonide
peripheral muscles exercise trainingOther
inspiratory muscle trainingDevice
Also called Threshold® Inspiratory Muscle Trainer, Healthscan, New Jersey, NJ, USA
Patients started breathing at a resistance that required generation of 30% of their PImax for one week. The load was then increased incrementally, 5-10%, to reach generation of 60% of their PImax at the end of the first month. Specific IMT was then continued at 60% of their PImax adjusted weekly to the new PImax achieved.
| Study group | Role | What they receive |
|---|---|---|
| Study group (group A) | Active comparator | pharmacologic treatment: theophylline "uniphyllin", long acting bronchodilators "foradil/spiriva" or combined LABD and inhaled steroids "miflonide" according to GOLD recommendations peripheral muscles exercise training: (upper limb and lower limb strength and endurance training) inspiratory muscle training: (at intensity that progressively increased from 30% to 60% of patients' maximal inspiratory pressure) Receives: Drug: theophylline, long acting bronchodilators (LABD) or combined LABD and inhaled steroids according to GOLD recommendations; Other: peripheral muscles exercise training; Device: inspiratory muscle training |
| control positive group (group B) | Active comparator | pharmacologic treatment: theophylline "uniphyllin", long acting bronchodilators "foradil/spiriva" or combined LABD and inhaled steroids "miflonide" according to GOLD recommendations peripheral muscles exercise training: (upper limb and lower limb strength and endurance training) Receives: Drug: theophylline, long acting bronchodilators (LABD) or combined LABD and inhaled steroids according to GOLD recommendations; Other: peripheral muscles exercise training |
| control negative group (group C) | Active comparator | pharmacologic treatment: theophylline "uniphyllin", long acting bronchodilators "foradil/spiriva" or combined LABD and inhaled steroids "miflonide" according to GOLD recommendations Receives: Drug: theophylline, long acting bronchodilators (LABD) or combined LABD and inhaled steroids according to GOLD recommendations |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in respiratory muscle strength
maximal inspiratory pressure, maximal expiratory pressure
Measured: after 4 weeks and after 8 weeks of study
changes in perception of dyspnea
modified Medical Research Council and modified Borg category scale
Measured: after 4 weeks and after 8 weeks of study
changes in exercise performance
6-min walk test
Measured: after 4 weeks and after 8 weeks of study
changes in quality of life
BODE index, St. George's Respiratory Questionnaire for COPD patients (SGRQ-C)
Measured: after 4 weeks and after 8 weeks of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2014 (estimated)
- Study startOct 2011
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Aboelkhair Abdallah, Mansoura University
- Investigators
- Ahmed S Elmorsi, MD, Study chair, Mansoura UniversityMohamad E Eldesoky, MD, Study director, Mansoura UniversityMona AA Mohsen, MD, Study director, Mansoura UniversityNesrien M Shalaby, MD, Study director, Mansoura UniversityDina A Abdallah, MSc, Principal investigator, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02257463
- Sponsor's protocol ID
- MD/4
- Status last verified
- Oct 2014
- First submitted
- 26 Sep 2014
- Last updated
- 8 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Inspiratory Muscle Training on Exercise Performance and Quality of Life in Patients With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT02257463
- Acronym / sponsor ID
- MD/4
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, inspiratory muscle training, dyspnea, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 6 Oct 2014 (estimated)
- 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.
The aim is to study effectiveness of inspiratory muscle training as a part of exercise training in patients with Chronic Obstructive Pulmonary Disease (COPD) and if it adds to general exercise training program in regard to respiratory muscle strength, dyspnea, exercise performance and quality of life.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Study group (group A) | Active comparator | Drug: theophylline, long acting bronchodilators (LABD) or combined LABD and inhaled steroids according to GOLD recommendations, Other: peripheral muscles exercise training, Device: inspiratory muscle trainingpharmacologic treatment: theophylline "uniphyllin", long acting bronchodilators "foradil/spiriva" or combined LABD and inhaled steroids "miflonide" according to GOLD recommendations peripheral muscles exercise training: (upper limb and lower limb strength and endurance training) inspiratory muscle training: (at intensity that progressively increased from 30% to 60% of patients' maximal inspiratory pressure) |
| control positive group (group B) | Active comparator | Drug: theophylline, long acting bronchodilators (LABD) or combined LABD and inhaled steroids according to GOLD recommendations, Other: peripheral muscles exercise trainingpharmacologic treatment: theophylline "uniphyllin", long acting bronchodilators "foradil/spiriva" or combined LABD and inhaled steroids "miflonide" according to GOLD recommendations peripheral muscles exercise training: (upper limb and lower limb strength and endurance training) |
| control negative group (group C) | Active comparator | Drug: theophylline, long acting bronchodilators (LABD) or combined LABD and inhaled steroids according to GOLD recommendationspharmacologic treatment: theophylline "uniphyllin", long acting bronchodilators "foradil/spiriva" or combined LABD and inhaled steroids "miflonide" according to GOLD recommendations |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Exsmokers
- Low PImax compared to reference values [lower limits of normal: 80 cmH2O for patients less than or equal 54 years old; 71 cmH2O for patients' age between 55-64 years; and 65 cmH2O for patients 65 years old ].
- Stable patients without history of exacerbation or hospitalization four weeks before starting the study.
Key exclusion criteria (13 listed)
- Lack of motivation and compliance.
- Patients with significant reversibility following bronchodilation defined as an increase in FEV1 of more than 12% and 200 ml from the pre-bronchodilator value
- Unstable cardiac disease [severe heart failure, dangerous dysrhythmias, recent myocardial infarction or unstable angina (within 4 weeks)].
- Uncontrolled hypertension
- Recent pneumothorax (within 6 weeks)
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 |
|---|---|---|
| theophylline, long acting bronchodilators (LABD) or combined LABD and inhaled steroids according to GOLD recommendationsAlso: uniphyllin, foradil, spiriva, miflonide | Drug | Study group (group A), control negative group (group C), control positive group (group B) |
| peripheral muscles exercise training | Other | Study group (group A), control positive group (group B) |
| inspiratory muscle trainingAlso: Threshold® Inspiratory Muscle Trainer, Healthscan, New Jersey, NJ, USAPatients started breathing at a resistance that required generation of 30% of their PImax for one week. The load was then increased incrementally, 5-10%, to reach generation of 60% of their PImax at the end of the first month. Specific IMT was then continued at 60% of their PImax adjusted weekly to the new PImax achieved. | Device | Study group (group A) |
Primary outcome
changes in respiratory muscle strength
Time frame: after 4 weeks and after 8 weeks of study
maximal inspiratory pressure, maximal expiratory pressure
changes in perception of dyspnea
Time frame: after 4 weeks and after 8 weeks of study
modified Medical Research Council and modified Borg category scale
changes in exercise performance
Time frame: after 4 weeks and after 8 weeks of study
6-min walk test
changes in quality of life
Time frame: after 4 weeks and after 8 weeks of study
BODE index, St. George's Respiratory Questionnaire for COPD patients (SGRQ-C)
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 8 Apr 2015.
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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.
Ahmed S Elmorsi, MD study chair
Mansoura University
Mohamad E Eldesoky, MD study director
Mansoura University
Mona AA Mohsen, MD study director
Mansoura University
Questions about this trial
What is this clinical trial studying?
A study testing theophylline, long acting bronchodilators (LABD) or combined LABD and inhaled steroids according to GOLD recommendations, peripheral muscles exercise training and inspiratory muscle training in people with Chronic Obstructive Pulmonary Disease, run by Mansoura University.
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 3 inclusion and 13 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 8 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
changes in respiratory muscle strength (time frame: after 4 weeks and after 8 weeks of study). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Apr 2015.