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Effects of Home-based Pulmonary Rehabilitation in Patients With Severe or Very Severe Chronic Obstructive Pulmonary Disease (COPD)

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ClinicalTrials.gov Identifier: NCT01198288
Recruitment Status : Unknown
Verified January 2012 by Marta Lazzeri, Associazione Riabilitatori Insufficienza Respiratoria.
Recruitment status was:  Recruiting
First Posted : September 10, 2010
Last Update Posted : January 31, 2012
Sponsor:
Information provided by (Responsible Party):
Marta Lazzeri, Associazione Riabilitatori Insufficienza Respiratoria

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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Other: domiciliary rehabilitation Other: Standard Care Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 182 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomised Controlled Trial on the Effects of Home-based Pulmonary Rehabilitation in Patients With Severe or Very Severe COPD
Study Start Date : September 2010
Estimated Primary Completion Date : September 2012
Estimated Study Completion Date : September 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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
Other: Standard Care
As describe in the standard care arm

Experimental: 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.

Other: domiciliary rehabilitation
a respiratory rehabilitation programme at the patient home




Primary Outcome Measures :
  1. meters as per walking test performance [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Quality of life [ Time Frame: 8 weeks ]
  2. Bode index [ Time Frame: 8 weeks ]
    This index is a combination of walking test result, Body Mass Index and respiratory measurement

  3. dyspnea [ Time Frame: 8 weeks ]
  4. relapses [ Time Frame: 8 weeks ]
  5. services utilization [ Time Frame: 8 weeks ]
    visits to the GP or Pneumologist that were not planned, hospital visits (emergency room )

  6. meters as per walking test performance [ Time Frame: 6 months ]
  7. Quality of life [ Time Frame: 6 months ]
  8. Bode index [ Time Frame: 6 months ]
    This index is a combination of walking test result, Body Mass Index and respiratory measurement

  9. dyspnea [ Time Frame: 6 months ]
  10. relapses [ Time Frame: 6 months ]
  11. services utilization [ Time Frame: 6 months ]
    visits to the GP or Pneumologist that were not planned, hospital visits (emergency room )

  12. meters as per walking test performance [ Time Frame: 12 months ]
  13. Quality of life [ Time Frame: 12 months ]
  14. Bode index [ Time Frame: 12 months ]
    This index is a combination of walking test result, Body Mass Index and respiratory measurement

  15. dyspnea [ Time Frame: 12 months ]
  16. relapses [ Time Frame: 12 months ]
  17. services utilization [ Time Frame: 12 months ]
    visits to the GP or Pneumologist that were not planned, hospital visits (emergency room )



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01198288


Contacts
Contact: Marta Lazzeri presidenza@arirassociazione.org

Locations
Italy
Unità di pneunologia, Ospedale di Busto Arsizio Recruiting
Busto Arsizio, Varese, Italy
Sponsors and Collaborators
Associazione Riabilitatori Insufficienza Respiratoria

Responsible Party: Marta Lazzeri, Dr, Associazione Riabilitatori Insufficienza Respiratoria
ClinicalTrials.gov Identifier: NCT01198288     History of Changes
Other Study ID Numbers: 01
First Posted: September 10, 2010    Key Record Dates
Last Update Posted: January 31, 2012
Last Verified: January 2012

Keywords provided by Marta Lazzeri, Associazione Riabilitatori Insufficienza Respiratoria:
COPD
Respiratory Physiotherapy

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases