Non Invasive Mechanical Ventilation in Chronic Respiratory Insufficiency Patients During Rehabilitation
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Purpose
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 the 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 after 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 2008) there was no significant difference between groups in the tolerance to the effort test.
Aim of the study is to evaluate if daily NIV during physical training augments the benefits of rehabilitation in CRI patients with nocturnal NIV compared with patients with nocturnal NIV performing training alone.
| Condition | Intervention |
|---|---|
|
Chronic Respiratory Insufficiency |
Other: NIV during rehabilitation Other: Rehabilitation without NIV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
- Effort tolerance measured by 6-minutes Walking test [ Time Frame: After 3 weeks ] [ Designated as safety issue: Yes ]Changes from baseline in 6-minutes Walking test
- Maximal Inspiratory Pressure/Maximal Expiratory Pressure [ Time Frame: After 3 weeks ] [ Designated as safety issue: Yes ]
- Quality of life MRF 28 [ Time Frame: After 3 weeks ] [ Designated as safety issue: Yes ]
- Gas analysis [ Time Frame: After 3 weeks ] [ Designated as safety issue: Yes ]
- Effort tolerance evaluated by 6-minutes walking test [ Time Frame: After 3 weeks ] [ Designated as safety issue: Yes ]Changes in 6-minutes walking test evaluated at the end of the program
- Endurance at cycloergometer test [ Time Frame: After 3 weeks ] [ Designated as safety issue: Yes ]
- Effort tolerance measured by 6-minutes Walking test [ Time Frame: Follow up at 3 months after the end of the protocol ] [ Designated as safety issue: Yes ]Changes in 6-minutes Walking test evaluated 3 months after the end of the protocol
| Estimated Enrollment: | 50 |
| Study Start Date: | March 2011 |
| Estimated Study Completion Date: | March 2013 |
| Estimated Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Rehabilitation without NIV
Rehabilitative training in patients without NIV
|
Other: Rehabilitation without NIV
Training in patients without NIV
Other Names:
|
| Experimental: Rehabilitation with NIV |
Other: NIV during rehabilitation
Addition of non invasive mechanical ventilation (NIV) during rehabilitation in patients with nocturnal NIV with respect to patients with nocturnal ventilation performing daily exercises without NIV
Other Names:
|
Detailed Description:
INTERVENTION
Group 1 (NIV during training + nocturnal NIV): This group 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 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 the 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 the 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% we need to enrol 25 patient for group.
Eligibility| Ages Eligible for Study: | 40 Years to 79 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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.
Contacts and Locations| Italy | |
| Fondazione Salvatore Maugeri | Recruiting |
| Lumezzane, Brescia, Italy, 25066 | |
| Contact: Katia Foglio, MD 0039+30+8253 ext 177 katia.foglio@fsm.it | |
| Sub-Investigator: Enrico M Clini, Prof | |
| Sub-Investigator: Nicolino Ambrosino, MD | |
| Sub-Investigator: Dycle Yilmaz, MD | |
| Principal Investigator: | Katia Foglio, MD | Fondazione Salvatore Maugeri |
More Information
No publications provided
| Responsible Party: | Katia Foglio, Principal investigator, Fondazione Salvatore Maugeri |
| ClinicalTrials.gov Identifier: | NCT01458314 History of Changes |
| Other Study ID Numbers: | CTS/10/01 |
| Study First Received: | October 12, 2011 |
| Last Updated: | October 21, 2011 |
| Health Authority: | Italy: Ethics Committee |
Keywords provided by Fondazione Salvatore Maugeri:
|
Physical exercise Rehabilitation NIV |
Additional relevant MeSH terms:
|
Respiratory Insufficiency Respiration Disorders Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on June 18, 2013