- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01854008
Urban Walking Circuits
May 12, 2013 updated by: Eulogio Pleguezuelos, Hospital de Mataró
Improving Physical Activity in Patients With Severe Chronic Obstructive Pulmonary Disease With Urban Walking Circuits
The aim of this study was to assess the effectiveness of the implementation of walking urban circuits in increasing the level of physical activity and exercise capacity in severe chronic obstructive pulmonary disease (COPD) patients after being enrolled in a pulmonary rehabilitation program.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
82
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Barcelona
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Mataro, Barcelona, Spain, 08304
- Eulogio Pleguezuelos
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- severe COPD (post-bronchodilator Forced expiratory volume in one second (FEV1)/ Forced vital capacity (FVC) <0.7 and FEV1 <50%) and stable disease defined as no exacerbation, hospital admission or change in treatment in the previous three months.
Exclusion Criteria:
- The exclusion criteria were: other significant respiratory disease (bronchiectasis, lung fibrosis, asthma, etc.), active smoking, severe cardiovascular, neurological, musculoskeletal and/or metabolic pathology that could interfere with the results, alcoholism (>80g/day) or severe malnutrition (BMI<19kg/m2).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: rehabilitation program more the urban circuit
One group, the urban circuit group (UCG), received a triptych that included urban walking circuits,the remaining patients formed the non circuit group (NCG).These circuits can be obtained on the website http://www.mataro.cat/web/portal/ca/salut/salut_publica/itineraris/index
|
included in a standard rehabilitation program + the urban circuit.
A total of 32 urban walking circuits were developed jointly with the town hall of Mataró(124,000 in habitants)and were included in a triptych called "A PEU, FEM SALUT!
Itineraris urbans per Mataró" http://www.mataro.cat/web/portal/ca/salut/salut_publica/itineraris/index
|
Experimental: rehabilitation program non circuit group .
One group, the urban circuit group (UCG), received a triptych that included urban walking circuits,the remaining patients formed the non circuit group (NCG)
|
Only rehabilitation program and general recommendations on physical activity and lifestyle .
No urbans circuits.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
walked in meters in the six minute walking test (6MWT)
Time Frame: Unlike walking meters of baseline and one year
|
The 6MWT was standardized following international recommendations.
Oxygen saturation and heart rate were recorded throughout the test using a pulsioximeter (Digit ® Finger Oximeter, Smiths Medical PM, USA).
Dyspnea was evaluated using the modified Borg scale at the beginning and end of the test
|
Unlike walking meters of baseline and one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2008
Primary Completion (Actual)
June 1, 2011
Study Completion (Actual)
June 1, 2011
Study Registration Dates
First Submitted
May 12, 2013
First Submitted That Met QC Criteria
May 12, 2013
First Posted (Estimate)
May 15, 2013
Study Record Updates
Last Update Posted (Estimate)
May 15, 2013
Last Update Submitted That Met QC Criteria
May 12, 2013
Last Verified
May 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- WALURB-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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