Inspiratory Muscle TrainingNCT03080662
Impact of Inspiratory Muscle Training on Daily Physical Activity (INAF)
A study testing ORYGEN DUAL Valve in people with Inspiratory Muscle Training, run by Parc de Salut Mar at 1 site in Spain.
Trial summary
The impact of the reduction of daily physical activity (DPA) in patients with COPD (chronic obstructive pulmonary disease) is a highly studied area, due to its impact on the quality of life and the clinical evolution of the disease . Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Inspiratory Muscle Training
- What is being tested?
- ORYGEN DUAL Valve
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 22 Jan 2015to 15 Mar 2018
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be eligible for the respiratory rehabilitation programme participants must have stable COPD (at least 4 weeks), inspiratory muscle weakness (PImax <70%) and pulmonary hyperinflation (TLC > 120%). Patient that have signed inform consent.
Who cannot join
- Hospitalization within the previous 14 days
- Current participation in rehabilitation program,
- Locomotor or neurological condition or disability limiting the ability to perform exercise,
- Lung transplantation or lung volume reduction surgery foreseen within 1 month after discharge.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Del Mar
Barcelona, Barcelona, 08003
Diego Agustin Rodriguez, PhD, 0034932483548, DARodriguez@parcdesalutmar.cat
About this study
The impact of the reduction of daily physical activity (DPA) in patients with COPD (chronic obstructive pulmonary disease) is a highly studied area, due to its impact on the quality of life and the clinical evolution of the disease . This fact has multifactorial components: its function is naturally diminished with time, and its effects on the loss of physical condition (decondition). However, dynamic hyperinflation and respiratory muscular dysfunction, especially in patients with more symptomatology, have been identified as those that have the most relevant factors that impact on daily physical activity Due to the detrimental effects of the pulmonary hyperinflation, the diaphragm is flatter and shorter, being in a position of mechanical disadvantage. This contributes to a reduced effort capacity and increase in the dyspnea of patients during daily activities.
Resistance training improves their exercise capacity and reduces dyspnea, however it does not improve inspiratory muscle strength. It is for this reason, that specific training of the inspiratory muscles, offers special interest in patients with decreased inspiratory muscle strength and pulmonary hyperinflation.
- Conditions
- Inspiratory Muscle Training
- Being tested
- ORYGEN DUAL Sham Valve, ORYGEN DUAL Valve
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ORYGEN DUAL Sham ValveDevice
Training of the inspiratory muscles during 5 weeks
ORYGEN DUAL ValveDevice
Training of the inspiratory muscles during 5 weeks
| Study group | Role | What they receive |
|---|---|---|
| Sham valve (Placebo) | Sham comparator | Sham Inspiratory valve (without resistance) Receives: Device: ORYGEN DUAL Sham Valve |
| Intervention | Experimental | Inspiratory valve with increase resistance Receives: Device: ORYGEN DUAL Valve |
What is being measured
The primary outcome is the main question the study is designed to answer.
improvement of daily physical activity
Change From Baseline at least 10% moderate to vigorous daily physical activity measured by accelerometer
Measured: Baseline and 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2017
- Study start22 Jan 2015
- Primary completion15 Dec 2017 (estimated)
- Study completion15 Mar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inspiratory Muscle TrainingStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Parc de Salut Mar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diego Agustín Rodríguez, Parc de Salut Mar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03080662
- Sponsor's protocol ID
- INAF
- Status last verified
- Mar 2017
- First submitted
- 7 Mar 2017
- Last updated
- 15 Mar 2017
- Results posted
- No
- Data monitoring committee
- 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 15 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Inspiratory Muscle Training on Daily Physical Activity (INAF)
- ClinicalTrials.gov ID
- NCT03080662
- Acronym / sponsor ID
- INAF
- Conditions
- Inspiratory Muscle Training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Parc de Salut MarUniversity, hospital or other
- Study start
- 22 Jan 2015 (actual)
- Primary completion
- 15 Dec 2017 (estimated)
- Study completion
- 15 Mar 2018 (estimated)
- First posted
- 15 Mar 2017 (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.
The impact of the reduction of daily physical activity (DPA) in patients with COPD (chronic obstructive pulmonary disease) is a highly studied area, due to its impact on the quality of life and the clinical evolution of the disease . This fact has multifactorial components: its function is naturally diminished with time, and its effects on the loss of physical condition (decondition). However, dynamic hyperinflation and respiratory muscular dysfunction, especially in patients with more symptomatology, have been identified as those that have the most relevant factors that impact on daily physical activity Due to the detrimental effects of the pulmonary hyperinflation, the diaphragm is flatter and shorter, being in a position of mechanical disadvantage. This contributes to a reduced effort capacity and increase in the dyspnea of patients during daily activities.
Resistance training improves their exercise capacity and reduces dyspnea, however it does not improve inspiratory muscle strength. It is for this reason, that specific training of the inspiratory muscles, offers special interest in patients with decreased inspiratory muscle strength and pulmonary hyperinflation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham valve (Placebo) | Sham comparator | Device: ORYGEN DUAL Sham ValveSham Inspiratory valve (without resistance) |
| Intervention | Experimental | Device: ORYGEN DUAL ValveInspiratory valve with increase resistance |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- To be eligible for the respiratory rehabilitation programme participants must have stable COPD (at least 4 weeks), inspiratory muscle weakness (PImax <70%) and pulmonary hyperinflation (TLC > 120%). Patient that have signed inform consent.
Key exclusion criteria (4 listed)
- Hospitalization within the previous 14 days
- Current participation in rehabilitation program,
- Locomotor or neurological condition or disability limiting the ability to perform exercise,
- Lung transplantation or lung volume reduction surgery foreseen within 1 month after discharge.
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 |
|---|---|---|
| ORYGEN DUAL Sham ValveTraining of the inspiratory muscles during 5 weeks | Device | Sham valve (Placebo) |
| ORYGEN DUAL ValveTraining of the inspiratory muscles during 5 weeks | Device | Intervention |
Primary outcome
improvement of daily physical activity
Time frame: Baseline and 5 weeks
Change From Baseline at least 10% moderate to vigorous daily physical activity measured by accelerometer
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2017.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ORYGEN DUAL Valve in people with Inspiratory Muscle Training, run by Parc de Salut Mar at 1 site in Spain.
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 1 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: status not confirmed, as of the sponsor's last update on 15 Mar 2017. 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 Spain. 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. 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 Diego Agustin Rodriguez, PhD (0034932483548, DARodriguez@parcdesalutmar.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
improvement of daily physical activity (time frame: Baseline and 5 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 15 Mar 2017.