Chronic Obstructive Pulmonary DiseasePhase 3NCT01198288
Effects of Home-based Pulmonary Rehabilitation in Patients With Severe or Very Severe Chronic Obstructive Pulmonary Disease (COPD)
A Phase 3 study testing domiciliary rehabilitation in people with Chronic Obstructive Pulmonary Disease, run by Associazione Riabilitatori Insufficienza Respiratoria at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- domiciliary rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2010to Sep 2012
- Phase
- Phase 3
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- - 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
Trial locations and contacts
1 site in 1 country.
Marta Lazzeri contact
Italy1 site, 1 recruiting
- Recruiting
Unità di pneunologia, Ospedale di Busto Arsizio
Busto Arsizio, Varese
About this study
Official title: Randomised Controlled Trial on the Effects of Home-based Pulmonary Rehabilitation in Patients With Severe or Very Severe COPD
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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- domiciliary rehabilitation, Standard Care
- Keywords
- COPD, Respiratory Physiotherapy
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
domiciliary rehabilitationOther
a respiratory rehabilitation programme at the patient home
Standard CareOther
As describe in the standard care arm
| Study group | Role | What they receive |
|---|---|---|
| Standard Care | Active comparator | 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 Receives: Other: Standard Care |
| domiciliary rehabilitation | Experimental | 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. Receives: Other: domiciliary rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
meters as per walking test performance
Measured: 8 weeks
Secondary outcomes (17)
Quality of life
Measured: 8 weeks
Bode index
This index is a combination of walking test result, Body Mass Index and respiratory measurement
Measured: 8 weeks
dyspnea
Measured: 8 weeks
relapses
Measured: 8 weeks
services utilization
visits to the GP or Pneumologist that were not planned, hospital visits (emergency room )
Measured: 8 weeks
meters as per walking test performance
Measured: 6 months
Quality of life
Measured: 6 months
Bode index
This index is a combination of walking test result, Body Mass Index and respiratory measurement
Measured: 6 months
dyspnea
Measured: 6 months
relapses
Measured: 6 months
services utilization
visits to the GP or Pneumologist that were not planned, hospital visits (emergency room )
Measured: 6 months
meters as per walking test performance
Measured: 12 months
Quality of life
Measured: 12 months
Bode index
This index is a combination of walking test result, Body Mass Index and respiratory measurement
Measured: 12 months
dyspnea
Measured: 12 months
relapses
Measured: 12 months
services utilization
visits to the GP or Pneumologist that were not planned, hospital visits (emergency room )
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionSep 2012 (estimated)
- Study completionSep 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 182 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Associazione Riabilitatori Insufficienza Respiratoria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marta Lazzeri, Associazione Riabilitatori Insufficienza Respiratoria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01198288
- Sponsor's protocol ID
- 01
- Status last verified
- Jan 2012
- First submitted
- 7 Sep 2010
- Last updated
- 31 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Trial on the Effects of Home-based Pulmonary Rehabilitation in Patients With Severe or Very Severe COPD
- ClinicalTrials.gov ID
- NCT01198288
- Acronym / sponsor ID
- 01
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, Respiratory Physiotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 182 participants (estimated)
- Lead sponsor
- Associazione Riabilitatori Insufficienza RespiratoriaUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Sep 2012 (estimated)
- Study completion
- Sep 2012 (estimated)
- First posted
- 10 Sep 2010 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Care | Active comparator | Other: Standard CareDrugs 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 |
| domiciliary rehabilitation | Experimental | Other: domiciliary rehabilitationSame 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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.)
- no signs of lung restriction (TLC≥80%)
- clinically stable for at least the last four weeks
- MRC ≥ 2
Key exclusion criteria (3 listed)
- - 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
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 |
|---|---|---|
| domiciliary rehabilitationa respiratory rehabilitation programme at the patient home | Other | domiciliary rehabilitation |
| Standard CareAs describe in the standard care arm | Other | Standard Care |
Primary outcome
meters as per walking test performance
Time frame: 8 weeks
17 secondary outcomes
Quality of life
Time frame: 8 weeks
Bode index
Time frame: 8 weeks
dyspnea
Time frame: 8 weeks
relapses
Time frame: 8 weeks
services utilization
Time frame: 8 weeks
meters as per walking test performance
Time frame: 6 months
Quality of life
Time frame: 6 months
Bode index
Time frame: 6 months
dyspnea
Time frame: 6 months
relapses
Time frame: 6 months
services utilization
Time frame: 6 months
meters as per walking test performance
Time frame: 12 months
Quality of life
Time frame: 12 months
Bode index
Time frame: 12 months
dyspnea
Time frame: 12 months
relapses
Time frame: 12 months
services utilization
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2012.
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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.
Marta Lazzeri contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing domiciliary rehabilitation in people with Chronic Obstructive Pulmonary Disease, run by Associazione Riabilitatori Insufficienza Respiratoria 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 8 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 31 Jan 2012. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marta Lazzeri (presidenza@arirassociazione.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
meters as per walking test performance (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Jan 2012.