Effects of Home-based Pulmonary Rehabilitation in Patients With Severe or Very Severe Chronic Obstructive Pulmonary Disease (COPD)
NCT ID: NCT01198288
Last Updated: 2012-01-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
182 participants
INTERVENTIONAL
2010-09-30
2012-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Standard Care
Drugs for COPD (as prescribed), oxygen therapy if needed\*, check-up by the general practitioner and/or respirologist as usual.
Educational leaflet regarding optimization of oxygen therapy and drugs; Benefits of physical activity and proposal of a programme of exercise training; Energy conservation techniques; Nutritional counselling; Activity of daily Living (ADL) diary; Prevention and management of acute exacerbation
Monthly phone call with the aim of verifying:
* the patients' clinical conditions;
* the patient's adherence to the pharmacological treatments prescribed
* the patient's compliance in filling out the clinical diary and the ADL diary
Standard Care
As describe in the standard care arm
domiciliary rehabilitation
Same as the standard care group plus 10 (ten) home-based visits supervised by a specifically trained respiratory therapist (education+exercise training) Autonomous home-based programme: The patients will be given instructions and training in order to continue the exercise training programme on the days the respiratory therapist is not visiting them.
Counselling addressed at the outdoor activities.
domiciliary rehabilitation
a respiratory rehabilitation programme at the patient home
Interventions
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domiciliary rehabilitation
a respiratory rehabilitation programme at the patient home
Standard Care
As describe in the standard care arm
Eligibility Criteria
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Inclusion Criteria
* Very severe COPD (FEV1/FVC \< 70% and FEV1 \< 30% pred.)
With the following characteristics:
* no signs of lung restriction (TLC≥80%)
* clinically stable for at least the last four weeks
* MRC ≥ 2
* no participation to PR programmes in the last year
FEV1= Forced expiratory volume in the 1st second FVC= Forced vital capacity TLC= Total Lung Capacity PaO2= Partial pressure of arterial oxygen
Exclusion Criteria
* Cognitive impairment that could limit the patient's participation to the activities of education and exercise, as assessed by the Mini Mental State (MMS) test \<26;
* Malignancies
ALL
No
Sponsors
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Associazione Riabilitatori Insufficienza Respiratoria
OTHER
Responsible Party
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Marta Lazzeri
Dr
Locations
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Unità di pneunologia, Ospedale di Busto Arsizio
Busto Arsizio, Varese, Italy
Countries
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Central Contacts
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Other Identifiers
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01
Identifier Type: -
Identifier Source: org_study_id