Non Invasive Mechanical Ventilation in Chronic Respiratory Insufficiency Patients During Rehabilitation
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
1 other identifier
interventional
35
1 country
1
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2011
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 12, 2011
CompletedFirst Posted
Study publicly available on registry
October 24, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedNovember 13, 2015
November 1, 2015
4.3 years
October 12, 2011
November 12, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Effort tolerance measured by 6-minutes Walking test
Changes from baseline in 6-minutes Walking test
After 3 weeks
Secondary Outcomes (6)
Maximal Inspiratory Pressure/Maximal Expiratory Pressure
After 3 weeks
Quality of life MRF 28
After 3 weeks
Gas analysis
After 3 weeks
Effort tolerance evaluated by 6-minutes walking test
After 3 weeks
Endurance at cycloergometer test
After 3 weeks
- +1 more secondary outcomes
Study Arms (2)
Rehabilitation without NIV
ACTIVE COMPARATORA usual rehabilitative training will be performed in patients using nocturnal NIV, without adoption of daily NIV
Daily NIV during rehabilitation
EXPERIMENTALDaily NIV will be adopted during the rehabilitation program in patients already using nocturnal NIV
Interventions
Addition of non invasive mechanical ventilation (NIV) during daily rehabilitation in patients using nocturnal NIV
Training in patients without NIV adoption
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fondazione Salvatore Maugerilead
- Azienda Ospedaliero, Universitaria Pisanacollaborator
- Ataturk Training and Research Hospitalcollaborator
Study Sites (1)
Fondazione Salvatore Maugeri
Lumezzane, Brescia, 25065, Italy
Related Publications (1)
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.
PMID: 28940820DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michele Vitacca, MD
Fondazione Salvatore Maugeri
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
October 12, 2011
First Posted
October 24, 2011
Study Start
March 1, 2011
Primary Completion
June 1, 2015
Study Completion
October 1, 2015
Last Updated
November 13, 2015
Record last verified: 2015-11