Chronic Respiratory InsufficiencyNCT01458314
Non Invasive Mechanical Ventilation in Chronic Respiratory Insufficiency Patients During Rehabilitation
A study testing Daily NIV during rehabilitation and Rehabilitation without NIV in people with Chronic Respiratory Insufficiency, run by Fondazione Salvatore Maugeri at 1 site in Italy.
Trial summary
Patients with Chronic Obstructive Pulmonary Disease (COPD) and chronic respiratory insufficiency (CRI) have severe dyspnoea during exercise at low load. Physiological studies performed in these patients during a unique session of training have shown a positive effect on exercise tolerance if non-invasive mechanical… Read more about this study
- Who is it for?
- Ages 40 to 79 years
- Conditions the study is for
- Chronic Respiratory Insufficiency
- What is being tested?
- Daily NIV during rehabilitation and Rehabilitation without NIV
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2011to Oct 2015
- 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 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A total of 50 patients aging 40-79 years will be enrolled ( 8 out of 50 will be from FSM in Lumezzane)
- Patients with chronic respiratory insufficiency (CRI) in treatment with nocturnal NIV from at least six months;
- Clinical stability (absence of disease re-exacerbations from at least 4 weeks before the study).
Who cannot join
- Cardiac diseases: unstable and/or exercise angina, congestive heart failure cardiac, uncontrolled cardiac arrhythmias, sinus tachycardia at rest (HR >120 bpm), hypertension at rest and/or during effort not adequately checked by therapy
- Orthopaedic and/or neuromuscular illnesses.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Additional Effect of Non Invasive Mechanical Ventilation During a Rehabilitative Program With Cycloergometer in Patients With Chronic Respiratory Insufficiency Using Nocturnal Home Ventilation
Patients with Chronic Obstructive Pulmonary Disease (COPD) and chronic respiratory insufficiency (CRI) have severe dyspnoea during exercise at low load. Physiological studies performed in these patients during a unique session of training have shown a positive effect on exercise tolerance if non-invasive mechanical ventilation (NIV) was added during incremental effort test or endurance. Menadue and coworkers (2009) have shown in CRI patients with hypercapnia, secondary to COPD or cifoscoliosis, that combination of NIV during arm effort test improved ability to perform the exercise. Similar result was not reached using NIV during walking. Further studies have underlined a positive effect of the ventilation therapy during exercise within specific programs of pulmonary rehabilitation (Corner 2009). Moreover, the addition of NIV to an exercise training (ET) program in COPD patients may produce greater benefits in exercise tolerance and quality of life than exercise training alone (Garrod 2000).
A great improvement in health-related quality of life, functional status and gas exchange in COPD patients with chronic hypercapnic respiratory failure with nocturnal NIV compared with patients in pulmonary rehabilitation alone has been also shown by Duieverman (2008). However, in the same study Duieverman did not show any significant difference between groups in terms of tolerance to effort test.
Aim of the study is to evaluate if application of daily NIV during physical training may increase the benefits of rehabilitation in CRI patients with nocturnal NIV compared with patients with nocturnal NIV performing training under spontaneous breathing.
Read the detailed description
INTERVENTION
Group 1 (NIV during training + nocturnal NIV): This group of patients will use the usual NIV during night and will perform a rehabilitative program of at least 20 sessions of training at cycloergometer under NIV.
NO INTERVENTION
Group 2 (training in Spontaneous Breathing [SB] + nocturnal NIV): This group of patients will use the usual NIV during night and will be trained in a rehabilitative daily program without NIV. This group will be considered the "control" group.
Sessions: 30 minutes/session, 2 times/day, 4-5 times a week for a total of 20-25 session in 3 weeks.
Intensity: each patient will start at 50% of each individual's maximum work capacity (cycloergometer) increasing up to the maximum tolerated, according to Maltais's protocol.
NIV SETTING:
Training: Facial mask with usual setting (Inspiratory Positive Airway Pressure [IPAP] 10-15; Expiratory Positive Airway Pressure [EPAP] 4-6 cmH20) with a possible adjustment in agreement with the comfort.
The adjustment of ventilation during training will be only within the first 3 sessions according to the following protocol:
COPD patients: increase up to 3 cmH2Os of EPAP and decrease up to 3 cmH2Os of IPAP.
Restricted patients: increase up to 3 cmH2Os of IPAP.
Nocturnal ventilation: mask and usual setting
The primary outcome of the study is evaluation of effort tolerance measured by 6 minutes Walking Test (6-min Walking Test). The hypothesis is to verify a percentage of variation between the two groups equal to 10% after the rehabilitative program. To get a study power of 80% and an alpha error <5% 25 patients for group had to be enrolled.
- Conditions
- Chronic Respiratory Insufficiency
- Being tested
- Daily NIV during rehabilitation, Rehabilitation without NIV
- Keywords
- Physical exercise, Rehabilitation, NIV
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daily NIV during rehabilitationOther
Also called Group 1, Intervention
Addition of non invasive mechanical ventilation (NIV) during daily rehabilitation in patients using nocturnal NIV
Rehabilitation without NIVOther
Also called Group 2, No intervention
Training in patients without NIV adoption
| Study group | Role | What they receive |
|---|---|---|
| Rehabilitation without NIV | Active comparator | A usual rehabilitative training will be performed in patients using nocturnal NIV, without adoption of daily NIV Receives: Other: Rehabilitation without NIV |
| Daily NIV during rehabilitation | Experimental | Daily NIV will be adopted during the rehabilitation program in patients already using nocturnal NIV Receives: Other: Daily NIV during rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effort tolerance measured by 6-minutes Walking test
Changes from baseline in 6-minutes Walking test
Measured: After 3 weeks
Secondary outcomes (6)
Maximal Inspiratory Pressure/Maximal Expiratory Pressure
Measured: After 3 weeks
Quality of life MRF 28
Measured: After 3 weeks
Gas analysis
Measured: After 3 weeks
Effort tolerance evaluated by 6-minutes walking test
Changes in 6-minutes walking test evaluated at the end of the program
Measured: After 3 weeks
Endurance at cycloergometer test
Measured: After 3 weeks
Effort tolerance measured by 6-minutes Walking test
Changes in 6-minutes Walking test evaluated 3 months after the end of the protocol
Measured: Follow up at 3 months after the end of the protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2011 (estimated)
- Study startMar 2011
- Primary completionJun 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Respiratory InsufficiencyStudies 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
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Salvatore Maugeri
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda Ospedaliero, Universitaria Pisana, Ataturk Training and Research Hospital
- Responsible party
- Principal investigator, Michele Vitacca, Fondazione Salvatore Maugeri
- Investigators
- Michele Vitacca, MD, Principal investigator, Fondazione Salvatore Maugeri
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01458314
- Sponsor's protocol ID
- CTS/10/01
- Status last verified
- Nov 2015
- First submitted
- 12 Oct 2011
- Last updated
- 13 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Vitacca M, Kaymaz D, Lanini B, Vagheggini G, Ergun P, Gigliotti F, Ambrosino N, Paneroni M. Non-invasive ventilation during cycle exercise training in patients with chronic respiratory failure on long-term ventilatory support: A randomized controlled trial. Respirology. 2018 Feb;23(2):182-189. doi: 10.1111/resp.13181. Epub 2017 Sep 22.
PubMed 28940820
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Additional Effect of Non Invasive Mechanical Ventilation During a Rehabilitative Program With Cycloergometer in Patients With Chronic Respiratory Insufficiency Using Nocturnal Home Ventilation
- ClinicalTrials.gov ID
- NCT01458314
- Acronym / sponsor ID
- CTS/10/01
- Conditions
- Chronic Respiratory Insufficiency
- Keywords
- Physical exercise, Rehabilitation, NIV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Fondazione Salvatore MaugeriUniversity, hospital or other
- Collaborators
- Azienda Ospedaliero, Universitaria Pisana, Ataturk Training and Research Hospital
- Study start
- Mar 2011
- Primary completion
- Jun 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 24 Oct 2011 (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.
Patients with Chronic Obstructive Pulmonary Disease (COPD) and chronic respiratory insufficiency (CRI) have severe dyspnoea during exercise at low load. Physiological studies performed in these patients during a unique session of training have shown a positive effect on exercise tolerance if non-invasive mechanical ventilation (NIV) was added during incremental effort test or endurance. Menadue and coworkers (2009) have shown in CRI patients with hypercapnia, secondary to COPD or cifoscoliosis, that combination of NIV during arm effort test improved ability to perform the exercise. Similar result was not reached using NIV during walking. Further studies have underlined a positive effect of the ventilation therapy during exercise within specific programs of pulmonary rehabilitation (Corner 2009). Moreover, the addition of NIV to an exercise training (ET) program in COPD patients may produce greater benefits in exercise tolerance and quality of life than exercise training alone (Garrod 2000).
A great improvement in health-related quality of life, functional status and gas exchange in COPD patients with chronic hypercapnic respiratory failure with nocturnal NIV compared with patients in pulmonary rehabilitation alone has been also shown by Duieverman (2008). However, in the same study Duieverman did not show any significant difference between groups in terms of tolerance to effort test.
Aim of the study is to evaluate if application of daily NIV during physical training may increase the benefits of rehabilitation in CRI patients with nocturnal NIV compared with patients with nocturnal NIV performing training under spontaneous breathing.
Detailed description
INTERVENTION
Group 1 (NIV during training + nocturnal NIV): This group of patients will use the usual NIV during night and will perform a rehabilitative program of at least 20 sessions of training at cycloergometer under NIV.
NO INTERVENTION
Group 2 (training in Spontaneous Breathing [SB] + nocturnal NIV): This group of patients will use the usual NIV during night and will be trained in a rehabilitative daily program without NIV. This group will be considered the "control" group.
Sessions: 30 minutes/session, 2 times/day, 4-5 times a week for a total of 20-25 session in 3 weeks.
Intensity: each patient will start at 50% of each individual's maximum work capacity (cycloergometer) increasing up to the maximum tolerated, according to Maltais's protocol.
NIV SETTING:
Training: Facial mask with usual setting (Inspiratory Positive Airway Pressure [IPAP] 10-15; Expiratory Positive Airway Pressure [EPAP] 4-6 cmH20) with a possible adjustment in agreement with the comfort.
The adjustment of ventilation during training will be only within the first 3 sessions according to the following protocol:
COPD patients: increase up to 3 cmH2Os of EPAP and decrease up to 3 cmH2Os of IPAP.
Restricted patients: increase up to 3 cmH2Os of IPAP.
Nocturnal ventilation: mask and usual setting
The primary outcome of the study is evaluation of effort tolerance measured by 6 minutes Walking Test (6-min Walking Test). The hypothesis is to verify a percentage of variation between the two groups equal to 10% after the rehabilitative program. To get a study power of 80% and an alpha error <5% 25 patients for group had to be enrolled.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rehabilitation without NIV | Active comparator | Other: Rehabilitation without NIVA usual rehabilitative training will be performed in patients using nocturnal NIV, without adoption of daily NIV |
| Daily NIV during rehabilitation | Experimental | Other: Daily NIV during rehabilitationDaily NIV will be adopted during the rehabilitation program in patients already using nocturnal NIV |
Who may qualify
- Ages
- 40 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- A total of 50 patients aging 40-79 years will be enrolled ( 8 out of 50 will be from FSM in Lumezzane)
- Patients with chronic respiratory insufficiency (CRI) in treatment with nocturnal NIV from at least six months;
- Clinical stability (absence of disease re-exacerbations from at least 4 weeks before the study).
Key exclusion criteria (2 listed)
- Cardiac diseases: unstable and/or exercise angina, congestive heart failure cardiac, uncontrolled cardiac arrhythmias, sinus tachycardia at rest (HR >120 bpm), hypertension at rest and/or during effort not adequately checked by therapy
- Orthopaedic and/or neuromuscular illnesses.
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 |
|---|---|---|
| Daily NIV during rehabilitationAlso: Group 1, InterventionAddition of non invasive mechanical ventilation (NIV) during daily rehabilitation in patients using nocturnal NIV | Other | Daily NIV during rehabilitation |
| Rehabilitation without NIVAlso: Group 2, No interventionTraining in patients without NIV adoption | Other | Rehabilitation without NIV |
Primary outcome
Effort tolerance measured by 6-minutes Walking test
Time frame: After 3 weeks
Changes from baseline in 6-minutes Walking test
6 secondary outcomes
Maximal Inspiratory Pressure/Maximal Expiratory Pressure
Time frame: After 3 weeks
Quality of life MRF 28
Time frame: After 3 weeks
Gas analysis
Time frame: After 3 weeks
Effort tolerance evaluated by 6-minutes walking test
Time frame: After 3 weeks
Endurance at cycloergometer test
Time frame: After 3 weeks
Effort tolerance measured by 6-minutes Walking test
Time frame: Follow up at 3 months after the end of the protocol
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 13 Nov 2015.
- Derived from this study: PubMed 28940820Vitacca M, Kaymaz D, Lanini B, Vagheggini G, Ergun P, Gigliotti F, Ambrosino N, Paneroni M. Non-invasive ventilation during cycle exercise training in patients with chronic respiratory failure on long-term ventilatory support: A randomized controlled trial. Respirology. 2018 Feb;23(2):182-189. doi: 10.1111/resp.13181. Epub 2017 Sep 22.
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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.
Michele Vitacca, MD principal investigator
Fondazione Salvatore Maugeri
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Daily NIV during rehabilitation and Rehabilitation without NIV in people with Chronic Respiratory Insufficiency, run by Fondazione Salvatore Maugeri at 1 site in Italy.
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 2 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 13 Nov 2015. 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 Italy. 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?
Effort tolerance measured by 6-minutes Walking test (time frame: After 3 weeks). 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 NCT01458314, which also lists 1 linked publication.
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 13 Nov 2015.