4-10 Week Observational Study Comparing 3 Management Strategies for Obstructive Chronic BronchoPneumopathy (OCBP) in Common Clinical Practice (OBALPA)

The management of patients with Obstructive Chronic BronchoPneumopathy (OCBP) is based on a progression of therapeutic options and on a sensitization to physical activity.

For these patients selected on OCBP stage 2, the treatment options include Long Acting Beta-Agonist Bronchodilator (LABA) or Long Acting Muscarinic Antagonist Anticholinergic (LAMA) or both (LAMA+LABA).

The purpose of this study is to observe in common clinical practice the benefit of physical activity on quality of life, dyspnoea and walking distance for these patients under treatment (LABA and/or LAMA) and to determine whether these 3 medical strategies (LABA/LAMA/LABA+LAMA) benefit from physical activity.

Study Overview

• Status: Unknown
• Conditions: Obstructive Chronic BronchoPneumopathy (OCBP)

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69004
    • Recruiting
    • Hospices Civils de Lyon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with Obstructive Chronic BronchoPneumopathy (OCBP) stage ≥ 2

Description

Inclusion Criteria:

• Patients with Obstructive Chronic BronchoPneumopathy stage ≥ 2.
• Patients under treatment with LABA or LAMA or LABA+LAMA since at least 1 month.
• VEMS/CVF<70%
• VEMS<80%
• Patients without regular physical activity and without physical activity program since 1 year.

Exclusion Criteria:

• Patients under treatment with LABA + inhaled Corticoids.
• Contraindication to physical activity.
• Patients with previous history of respiratory exacerbations.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in quality of life after 4 to 10 weeks of physical activity program	Evaluation of quality of life by specific questionnaires (VQ11, RICCI Test) and by specific parameters such as: spirometry, dyspnea, Body Mass Index (BMI), 6 minute Stepper Test (TS6), Body mass index, airflow Obstruction, Dyspnea and Exercise tolerance (BODE), O2 maximal Volume (VO2max) or Electrocardiogram (ECG).	Visit 1 before physical activity program and Visit 2 after 4 to 10 weeks of physical activity program

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medical Research Council dyspnea scale (grade degree 0 to 4)activity	Grade Degree of breathlessness related to activities (o to 4) : 0 : Not troubled by breathlessness except on strenuous exercise; : Short of breath when hurrying or walking up a slight hill; : Walks slower than contemporaries on level ground because of breathlessness, or has to stop for breath when walking at own pace; : Stops for breath after walking about 100m or after a few minutes on level ground; : Too breathless to leave the house, or breathless when dressing or undressing	Grade degree of dyspnea will be evaluated one time before and after the physical activity program an expected average of 10 weeks.
6 Minute Walking Test (6MWT) (unit : meter)	The original purpose of the six minute walk was to test exercise tolerance in chronic respiratory disease and heart failure. The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes.	6MWT will be realized one time before and after the physical activity program an expected average of 10 weeks.
Actimetry by accelerometer (unit : number of body movement)	Actimetry by accelerometer to assess physical activity. Technically, an accelerometer consists of a device with a piezoelectric sensor that registers physical activity via body movement (acceleration) produced during a limited period of time.	Accelerometer will be installed one time before and after the physical activity program an expected average of 10 weeks.

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Collaborators: Novartis
• Investigators: Principal Investigator: Gilles Devouassoux, MD, Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Anticipated): December 1, 2016
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: May 27, 2013
• First Submitted That Met QC Criteria: June 19, 2013
• First Posted (Estimate): June 24, 2013

Study Record Updates

• Last Update Posted (Estimate): May 10, 2016
• Last Update Submitted That Met QC Criteria: May 9, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: 2012-746