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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 May 2016 |
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Main ID: |
NCT02437994 |
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Date of registration:
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21/04/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Pulmonary Rehabilitation Program and PROactive Tool
PROactive |
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Scientific title:
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Impact of a Pulmonary Rehabilitation Program on the PROactive Tool |
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Date of first enrolment:
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October 2013 |
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Target sample size:
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115 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02437994 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
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Phase:
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N/A
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Countries of recruitment
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Greece
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Contacts
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Name:
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CHARALAMBOS ROUSSOS, PhD, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Thorax Research Foundation |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
Clinically stable patients with COPD will be recruited from the academic centers'
Outpatient Clinic on the following entry criteria:
1. a post-bronchodilator forced expiratory volume in one second (FEV1) <70% predicted
without significant reversibility (<12% change of the initial FEV1 value or <200 ml)
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2. optimal medical therapy according to Global Initiative for Chronic Obstructive Lung
Disease (GOLD) (6).
Exclusion Criteria:
1. Orthopedic, neurological, and other musculoskeletal complaints that could impair
normal movement patterns,
2. respiratory diseases other than COPD (e.g. asthma),
3. hospital admission or COPD exacerbations within the previous 4 weeks
4. patients not on optimal pharmacotherapy.
Age minimum:
40 Years
Age maximum:
70 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Chronic Obstructive Pulmonary Disease
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Intervention(s)
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Behavioral: Pulmonary Rehabilitation
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Primary Outcome(s)
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Proactive tool (clinical visit version)
[Time Frame: 7 days]
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Secondary Outcome(s)
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Daily Physical activity as measured by a validated for COPD patients triaxial accelerometers
[Time Frame: 7 days]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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