Chronic Obstructive Pulmonary DiseaseIMTGETNCT02392715
Inspiratory Muscle Training Combined With General Exercise Training in COPD
A study testing Inspiratory muscle training with Threshold by respironics in people with Chronic Obstructive Pulmonary Disease, run by Hôpital Riviera-Chablais, Vaud-Valais.
Trial summary
Chronic Obstructive Pulmonary Disease (COPD) is a frequent disease, with increasing prevalence. Pulmonary rehabilitation through general exercise training (GET) is a corner stone of COPD care. Inspiratory muscle training (IMT) as a stand-alone therapy decreases dyspnea and improves exercise capacity. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Inspiratory muscle training with Threshold by respironics
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Apr 2015to Dec 2016
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COPD demonstrated by spirometry using Gold Criteria
- Patient referred by a pneumologist to the ambulatory pulmonary rehabilitation program at the Riviera-Chablais Hospital, Monthey
- Patient with maximal inspiratory pressure < 60 cmH20
- Patient older than 40 years
Who cannot join
- Orthopaedic or neurological troubles that could slant the 6 minute walking test
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Inspiratory Muscle Training Combined With General Exercise Training, Compared to General Exercise Training Alone in Patients With COPD: Randomized Controlled Trial
Chronic Obstructive Pulmonary Disease (COPD) is a frequent disease, with increasing prevalence. Pulmonary rehabilitation through general exercise training (GET) is a corner stone of COPD care. Inspiratory muscle training (IMT) as a stand-alone therapy decreases dyspnea and improves exercise capacity. Whether IMT combined with GET adds a supplementary benefit in the rehabilitation of COPD patients is however uncertain.
Read the detailed description
Prospective, parallel-group, randomized controlled trial
80 COPD patients will be randomized into two groups. One group will receive general exercise training combined with inspiratory muscle training, 3 times a week, for a total of 36 sessions. The other group will receive general exercise training combined with shame inspiratory muscle training, 3 times a week, for a total of 36 sessions.
We will assess the difference of improvement in exercise capacity between the 2 groups with the 6 minute walking test. We will also assess the difference of improvement in quality of life with St-George's respiratory questionnaire. Finally the difference of improvement in maximal inspiratory pressure will be determined.
Patients and investigators assessing the outcomes will be blinded to group allocation.
Written informed consent will be obtained from each subject. The data will be treated anonymously.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Inspiratory muscle training with Threshold by respironics, Sham Inspiratory muscle training
- Keywords
- Inspiratory muscle training, General exercise training, pulmonary rehabilitation, chronic obstructive pulmonary disease
- 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.
Inspiratory muscle training with Threshold by respironicsDevice
Inspiratory muscle training
15 minutes, 3x/weeks, 36 sessions
Intensity: 15% of PiMax during the first week. Then increment of 5% each session until 60% of PiMax after the first month. The PiMax will be reassessed after 12 and 24 sessions in order to readjust the 60% of PiMax.
Sham Inspiratory muscle trainingDevice
with Threshold by respironics
15 minutes, 3x/weeks, 36 sessions
Intensity: 5 centimeters of water (cmH20)
| Study group | Role | What they receive |
|---|---|---|
| Intervention cohort | Experimental | 36 sessions of 60 - 75 minutes with a frequency of 3x/week
30' endurance training, 15' strength training, 15' inspiratory muscle training with Threshold by Respironics
Inspiratory muscle training intensity: 15% of maximal inspiratory pressure (PiMax) during the first week. Then increment of 5% each session until 60% of PiMax after the first month. The PiMax will be reassessed after 12 and 24 sessions in order to readjust the 60% of PiMax. Receives: Device: Inspiratory muscle training with Threshold by respironics |
| Control cohort | Sham comparator | 36 sessions of 60 - 75 minutes with a frequency of 3x/week
30' endurance training, 15' strength training, 15' sham inspiratory muscle training with Threshold by Respironics
Sham inspiratory muscle training intensity : 5 centimeters of water (cmH20) Receives: Device: Sham Inspiratory muscle training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise capacity (six minute walking test)
exercise capacity will be assessed by a six minute walking test
Measured: 12 weeks
Secondary outcomes (2)
Quality of Life (St-George's Respiratory questionnaire)
Quality of Life will be assessed by St-George's Respiratory questionnaire
Measured: 12 weeks
Maximal inspiratory pressure (MicroRPM by MicroMedical)
Inspiratory maximal pressure will be assessed by the MicroRPM by MicroMedical
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2015 (estimated)
- Study startApr 2015
- Primary completionOct 2016 (estimated)
- Study completionDec 2016 (estimated)
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.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hôpital Riviera-Chablais, Vaud-Valais
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stéphanie Vaudan, Hôpital Riviera-Chablais, Vaud-Valais
- Investigators
- Stéphanie Vaudan, BSc, Principal investigator, stephanie.vaudan@hopitalrivierachablais.ch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02392715
- Sponsor's protocol ID
- 003/15
- Acronym
- IMTGET
- Status last verified
- Mar 2015
- First submitted
- 13 Mar 2015
- Last updated
- 30 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inspiratory Muscle Training Combined With General Exercise Training, Compared to General Exercise Training Alone in Patients With COPD: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02392715
- Acronym / sponsor ID
- IMTGET / 003/15
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Inspiratory muscle training, General exercise training, pulmonary rehabilitation, chronic obstructive pulmonary disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Hôpital Riviera-Chablais, Vaud-ValaisUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 19 Mar 2015 (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.
Chronic Obstructive Pulmonary Disease (COPD) is a frequent disease, with increasing prevalence. Pulmonary rehabilitation through general exercise training (GET) is a corner stone of COPD care. Inspiratory muscle training (IMT) as a stand-alone therapy decreases dyspnea and improves exercise capacity. Whether IMT combined with GET adds a supplementary benefit in the rehabilitation of COPD patients is however uncertain.
Detailed description
Prospective, parallel-group, randomized controlled trial
80 COPD patients will be randomized into two groups. One group will receive general exercise training combined with inspiratory muscle training, 3 times a week, for a total of 36 sessions. The other group will receive general exercise training combined with shame inspiratory muscle training, 3 times a week, for a total of 36 sessions.
We will assess the difference of improvement in exercise capacity between the 2 groups with the 6 minute walking test. We will also assess the difference of improvement in quality of life with St-George's respiratory questionnaire. Finally the difference of improvement in maximal inspiratory pressure will be determined.
Patients and investigators assessing the outcomes will be blinded to group allocation.
Written informed consent will be obtained from each subject. The data will be treated anonymously.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention cohort | Experimental | Device: Inspiratory muscle training with Threshold by respironics36 sessions of 60 - 75 minutes with a frequency of 3x/week 30' endurance training, 15' strength training, 15' inspiratory muscle training with Threshold by Respironics Inspiratory muscle training intensity: 15% of maximal inspiratory pressure (PiMax) during the first week. Then increment of 5% each session until 60% of PiMax after the first month. The PiMax will be reassessed after 12 and 24 sessions in order to readjust the 60% of PiMax. |
| Control cohort | Sham comparator | Device: Sham Inspiratory muscle training36 sessions of 60 - 75 minutes with a frequency of 3x/week 30' endurance training, 15' strength training, 15' sham inspiratory muscle training with Threshold by Respironics Sham inspiratory muscle training intensity : 5 centimeters of water (cmH20) |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- COPD demonstrated by spirometry using Gold Criteria
- Patient referred by a pneumologist to the ambulatory pulmonary rehabilitation program at the Riviera-Chablais Hospital, Monthey
- Patient with maximal inspiratory pressure < 60 cmH20
- Patient older than 40 years
Key exclusion criteria (1 listed)
- Orthopaedic or neurological troubles that could slant the 6 minute walking test
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 |
|---|---|---|
| Inspiratory muscle training with Threshold by respironicsInspiratory muscle training 15 minutes, 3x/weeks, 36 sessions Intensity: 15% of PiMax during the first week. Then increment of 5% each session until 60% of PiMax after the first month. The PiMax will be reassessed after 12 and 24 sessions in order to readjust the 60% of PiMax. | Device | Intervention cohort |
| Sham Inspiratory muscle trainingwith Threshold by respironics 15 minutes, 3x/weeks, 36 sessions Intensity: 5 centimeters of water (cmH20) | Device | Control cohort |
Primary outcome
Exercise capacity (six minute walking test)
Time frame: 12 weeks
exercise capacity will be assessed by a six minute walking test
2 secondary outcomes
Quality of Life (St-George's Respiratory questionnaire)
Time frame: 12 weeks
Maximal inspiratory pressure (MicroRPM by MicroMedical)
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 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.
Stéphanie Vaudan, BSc principal investigator
stephanie.vaudan@hopitalrivierachablais.ch
Questions about this trial
What is this clinical trial studying?
A study testing Inspiratory muscle training with Threshold by respironics in people with Chronic Obstructive Pulmonary Disease, run by Hôpital Riviera-Chablais, Vaud-Valais.
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 1 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 30 Mar 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. Some participants in this study may receive a placebo. 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?
Contact Stéphanie Vaudan, BSc (+41 24 473 18 99, stephanie.vaudan@hopitalrivierachablais.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise capacity (six minute walking test) (time frame: 12 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 30 Mar 2015.