Back to resultsEffects of Home-based Pulmonary Rehabilitation in Patients With Severe or Very Severe Chronic Obstructive Pulmonary Disease (COPD)
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Unknown status
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
domiciliary rehabilitation
Standard Care
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD, Respiratory Physiotherapy
Eligibility Criteria
Inclusion Criteria:
- Severe COPD (FEV1/FVC < 70% and FEV1 < 50% pred.) associated to hypoxaemic chronic respiratory insufficiency (PaO2 < 60mmHg) or
- 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:
- - Muscular-skeletal impairment that could limit the patient's participation to the exercise programme;
- 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
Sites / Locations
- Unità di pneunologia, Ospedale di Busto ArsizioRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Standard Care
domiciliary rehabilitation
Arm Description
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
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.
Outcomes
Primary Outcome Measures
meters as per walking test performance
Secondary Outcome Measures
Quality of life
Bode index
This index is a combination of walking test result, Body Mass Index and respiratory measurement
dyspnea
relapses
services utilization
visits to the GP or Pneumologist that were not planned, hospital visits (emergency room )
meters as per walking test performance
Quality of life
Bode index
This index is a combination of walking test result, Body Mass Index and respiratory measurement
dyspnea
relapses
services utilization
visits to the GP or Pneumologist that were not planned, hospital visits (emergency room )
meters as per walking test performance
Quality of life
Bode index
This index is a combination of walking test result, Body Mass Index and respiratory measurement
dyspnea
relapses
services utilization
visits to the GP or Pneumologist that were not planned, hospital visits (emergency room )
Full Information
NCT ID
NCT01198288
First Posted
September 7, 2010
Last Updated
January 30, 2012
Sponsor
Associazione Riabilitatori Insufficienza Respiratoria
1. Study Identification
Unique Protocol Identification Number
NCT01198288
Brief Title
Effects of Home-based Pulmonary Rehabilitation in Patients With Severe or Very Severe Chronic Obstructive Pulmonary Disease (COPD)
Official Title
Randomised Controlled Trial on the Effects of Home-based Pulmonary Rehabilitation in Patients With Severe or Very Severe COPD
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Unknown status
Study Start Date
September 2010 (undefined)
Primary Completion Date
September 2012 (Anticipated)
Study Completion Date
September 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Associazione Riabilitatori Insufficienza Respiratoria
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will investigate if adding a domiciliary respiratory physiotherapy treatment to standard care in patients with chronic obstructive pulmonary disease (COPD) can improve physical function (walking test) and quality of life.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
COPD, Respiratory Physiotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
182 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard Care
Arm Type
Active Comparator
Arm Description
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
Arm Title
domiciliary rehabilitation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
domiciliary rehabilitation
Intervention Description
a respiratory rehabilitation programme at the patient home
Intervention Type
Other
Intervention Name(s)
Standard Care
Intervention Description
As describe in the standard care arm
Primary Outcome Measure Information:
Title
meters as per walking test performance
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Quality of life
Time Frame
8 weeks
Title
Bode index
Description
This index is a combination of walking test result, Body Mass Index and respiratory measurement
Time Frame
8 weeks
Title
dyspnea
Time Frame
8 weeks
Title
relapses
Time Frame
8 weeks
Title
services utilization
Description
visits to the GP or Pneumologist that were not planned, hospital visits (emergency room )
Time Frame
8 weeks
Title
meters as per walking test performance
Time Frame
6 months
Title
Quality of life
Time Frame
6 months
Title
Bode index
Description
This index is a combination of walking test result, Body Mass Index and respiratory measurement
Time Frame
6 months
Title
dyspnea
Time Frame
6 months
Title
relapses
Time Frame
6 months
Title
services utilization
Description
visits to the GP or Pneumologist that were not planned, hospital visits (emergency room )
Time Frame
6 months
Title
meters as per walking test performance
Time Frame
12 months
Title
Quality of life
Time Frame
12 months
Title
Bode index
Description
This index is a combination of walking test result, Body Mass Index and respiratory measurement
Time Frame
12 months
Title
dyspnea
Time Frame
12 months
Title
relapses
Time Frame
12 months
Title
services utilization
Description
visits to the GP or Pneumologist that were not planned, hospital visits (emergency room )
Time Frame
12 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Severe COPD (FEV1/FVC < 70% and FEV1 < 50% pred.) associated to hypoxaemic chronic respiratory insufficiency (PaO2 < 60mmHg) or
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:
- Muscular-skeletal impairment that could limit the patient's participation to the exercise programme;
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marta Lazzeri
Email
presidenza@arirassociazione.org
Facility Information:
Facility Name
Unità di pneunologia, Ospedale di Busto Arsizio
City
Busto Arsizio
State/Province
Varese
Country
Italy
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
Effects of Home-based Pulmonary Rehabilitation in Patients With Severe or Very Severe Chronic Obstructive Pulmonary Disease (COPD)
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