Chronic Obstructive Pulmonary DiseaseNCT04929990
The Effect of Respiratory Muscle Training for Patients With COPD and Mild Cognitive Impairment
A study testing Respiratory muscle training in people with Chronic Obstructive Pulmonary Disease and Mild Cognitive Impairment, run by Taichung Veterans General Hospital at 1 site in Taiwan.
Trial summary
Patients with COPD and MCI received either inspiratory muscle training or inspiratory plus expiratory muscle training and compared the therapeutic effects Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Mild Cognitive Impairment
- What is being tested?
- Respiratory muscle training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTaiwan
- Study dates
- 7 Aug 2018to 2 Jun 2021
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 1. Having definite diagnosis of COPD, namely the value of the FEV1 divided by forced vital capacity (FVC) 10 to 15 minutes after beta-2 agonist inhalation being less than 0.7.
- 2. The score of Mini-Mental State Examination (MMSE) being between 23 and 27
Who cannot join
- 1. Being not able to follow instructions on respiratory muscle training or complete the questionnaires of our study due to cognitive impairment.
- 2. Having difficulty to complete the cardiopulmonary exercise testing or the six minute walking test (6MWT) due to high risk cardiopulmonary diseases or other orthopedic conditions.
- 3. Having the diagnosis of lung cancer or history of receiving thoracoabdominal surgery
- 4. Having Body Mass Index more than 30
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Therapeutic Effect of Inspiratory and Expiratory Muscle Strengthening Training on Patients With COPD and Mild Cognitive Impairment
Patients with COPD and MCI received either inspiratory muscle training or inspiratory plus expiratory muscle training and compared the therapeutic effects
Read the detailed description
Patients with COPD and MCI were recruited, and were randomly assigned to the experimental group and the control group. The experimental group consisted of EMT and IMT for a total of 8 weeks, while the control group received IMT only. Outcomes measured and compared in this cohort were diaphragmatic thickness fraction and excursion examined by ultrasound, the dyspnea score of modified Medical Research Council (mMRC), the cognitive score of Mini-Mental State Examination (MMSE), and the score of COPD Assessment Test (CAT). In addition, the pulmonary function test, the cardiopulmonary exercise test, and the physiology performance of six minute walking test were also obtained. We also analyzed the difference of each parameters before and after training in each patient.
- Being tested
- Respiratory muscle training
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respiratory muscle trainingBehavioural
Inspiratory and expiratory muscle training were performed using a breathing trainer (Dofin DT11/14, Galemed Co. Ltd, Taiwan) for 30 minutes a day with a total of eight weeks. Before the training, the MIP and maximal expiratory pressure (MEP) were documented by the best performance of three trials with a digital pressure gauge (GB60, Jitto International Co. Ltd, Taiwan)
| Study group | Role | What they receive |
|---|---|---|
| Inpiratory and expiratory muscle training | Experimental | The initial intensity of training was set on 30% of the MIP and MEP for inspiratory and expiratory muscle training, respectively. The intensity was adjusted to add 5% of resistance each week Receives: Behavioral: Respiratory muscle training |
| Inspiratory muscle training | Active comparator | The initial resistance of the breathing trainer was also set on 30% of MIP, and the following adjustments were also in accordance to the protocol of the experimental group Receives: Behavioral: Respiratory muscle training |
What is being measured
The primary outcome is the main question the study is designed to answer.
MMSE
Mini-Mental State Examination
Measured: 8 weeks
Secondary outcomes (14)
Diaphragmatic thickness fraction
Diaphragmatic thickness fraction on ultrasonography
Measured: 8 weeks
chronic obstructive pulmonary disease assessment test (CAT)
questionnaire of dyspnea
Measured: 8 weeks
diffusing capacity of the lung for carbon monoxide (DLCO)
diffusing capacity of the lung for carbon monoxide (DLCO) in pulmonary function test
Measured: 8 weeks
dead space fraction (Vd/Vt)
dead space fraction (Vd/Vt) in cardiopulmonary function test
Measured: 8 weeks
the distance walked in 6 minutes
the distance walked in 6 minutes
Measured: 8 weeks
Diaphragmatic excursion
Diaphragmatic excursion on ultrasonography
Measured: 8 weeks
forced vital capacity
forced vital capacity tested in pulmonary function test
Measured: 8 weeks
forced expiratory volume in 1 second
forced expiratory volume in 1 second in pulmonary function test
Measured: 8 weeks
forced expiratory volume in 1 second divided by forced vital capacity
forced expiratory volume in 1 second divided by forced vital capacity in pulmonary function test
Measured: 8 weeks
DLCO divided by alveolar volume (VA)
DLCO divided by alveolar volume (VA) in pulmonary function test
Measured: 8 weeks
modified Medical Research Council (mMRC)
questionnaire of dyspnea
Measured: 8 weeks
minute ventilation to carbon dioxide output (VE/VCO2) slope
minute ventilation to carbon dioxide output (VE/VCO2) slope in cardiopulmonary function test
Measured: 8 weeks
the change of oxygen saturation in 6 minutes walking test
the change of oxygen saturation in 6 minutes walking test
Measured: 8 weeks
the change of Borg scale in 6 minutes walking test
the change of Borg scale in 6 minutes walking test
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start7 Aug 2018
- Primary completion6 Apr 2021
- Study completion2 Jun 2021
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 Taichung Veterans General HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yuan-Yang Cheng, Study director, Taichung Veterans General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04929990
- Sponsor's protocol ID
- CF18259A
- Status last verified
- Jun 2021
- First submitted
- 3 Jun 2021
- Last updated
- 18 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Therapeutic Effect of Inspiratory and Expiratory Muscle Strengthening Training on Patients With COPD and Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT04929990
- Acronym / sponsor ID
- CF18259A
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Study start
- 7 Aug 2018 (actual)
- Primary completion
- 6 Apr 2021 (actual)
- Study completion
- 2 Jun 2021 (actual)
- First posted
- 18 Jun 2021 (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.
Patients with COPD and MCI received either inspiratory muscle training or inspiratory plus expiratory muscle training and compared the therapeutic effects
Detailed description
Patients with COPD and MCI were recruited, and were randomly assigned to the experimental group and the control group. The experimental group consisted of EMT and IMT for a total of 8 weeks, while the control group received IMT only. Outcomes measured and compared in this cohort were diaphragmatic thickness fraction and excursion examined by ultrasound, the dyspnea score of modified Medical Research Council (mMRC), the cognitive score of Mini-Mental State Examination (MMSE), and the score of COPD Assessment Test (CAT). In addition, the pulmonary function test, the cardiopulmonary exercise test, and the physiology performance of six minute walking test were also obtained. We also analyzed the difference of each parameters before and after training in each patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inpiratory and expiratory muscle training | Experimental | Behavioral: Respiratory muscle trainingThe initial intensity of training was set on 30% of the MIP and MEP for inspiratory and expiratory muscle training, respectively. The intensity was adjusted to add 5% of resistance each week |
| Inspiratory muscle training | Active comparator | Behavioral: Respiratory muscle trainingThe initial resistance of the breathing trainer was also set on 30% of MIP, and the following adjustments were also in accordance to the protocol of the experimental group |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 1. Having definite diagnosis of COPD, namely the value of the FEV1 divided by forced vital capacity (FVC) 10 to 15 minutes after beta-2 agonist inhalation being less than 0.7.
- 2. The score of Mini-Mental State Examination (MMSE) being between 23 and 27
Key exclusion criteria (4 listed)
- 1. Being not able to follow instructions on respiratory muscle training or complete the questionnaires of our study due to cognitive impairment.
- 2. Having difficulty to complete the cardiopulmonary exercise testing or the six minute walking test (6MWT) due to high risk cardiopulmonary diseases or other orthopedic conditions.
- 3. Having the diagnosis of lung cancer or history of receiving thoracoabdominal surgery
- 4. Having Body Mass Index more than 30
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 |
|---|---|---|
| Respiratory muscle trainingInspiratory and expiratory muscle training were performed using a breathing trainer (Dofin DT11/14, Galemed Co. Ltd, Taiwan) for 30 minutes a day with a total of eight weeks. Before the training, the MIP and maximal expiratory pressure (MEP) were documented by the best performance of three trials with a digital pressure gauge (GB60, Jitto International Co. Ltd, Taiwan) | Behavioural | Inpiratory and expiratory muscle training, Inspiratory muscle training |
Primary outcome
MMSE
Time frame: 8 weeks
Mini-Mental State Examination
14 secondary outcomes
Diaphragmatic thickness fraction
Time frame: 8 weeks
chronic obstructive pulmonary disease assessment test (CAT)
Time frame: 8 weeks
diffusing capacity of the lung for carbon monoxide (DLCO)
Time frame: 8 weeks
dead space fraction (Vd/Vt)
Time frame: 8 weeks
the distance walked in 6 minutes
Time frame: 8 weeks
Diaphragmatic excursion
Time frame: 8 weeks
forced vital capacity
Time frame: 8 weeks
forced expiratory volume in 1 second
Time frame: 8 weeks
forced expiratory volume in 1 second divided by forced vital capacity
Time frame: 8 weeks
DLCO divided by alveolar volume (VA)
Time frame: 8 weeks
modified Medical Research Council (mMRC)
Time frame: 8 weeks
minute ventilation to carbon dioxide output (VE/VCO2) slope
Time frame: 8 weeks
the change of oxygen saturation in 6 minutes walking test
Time frame: 8 weeks
the change of Borg scale in 6 minutes walking test
Time frame: 8 weeks
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 18 Jun 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.
Yuan-Yang Cheng study director
Taichung Veterans General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Respiratory muscle training in people with Chronic Obstructive Pulmonary Disease and Mild Cognitive Impairment, run by Taichung Veterans General Hospital at 1 site in Taiwan.
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 2 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 18 Jun 2021. 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 Taiwan. 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?
MMSE (time frame: 8 weeks). 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 18 Jun 2021.