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Urban Walking Circuits

Primary Purpose

Severe Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
rehabilitation more the urban circuit
rehabilitation program but not given urbane circuits
Sponsored by
Hospital de Mataró
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Severe Chronic Obstructive Pulmonary Disease focused on measuring Exercise, Physical activity, Rehabilitation, COPD.

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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).

Sites / Locations

  • Eulogio Pleguezuelos

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

rehabilitation program more the urban circuit

rehabilitation program non circuit group .

Arm Description

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

One group, the urban circuit group (UCG), received a triptych that included urban walking circuits,the remaining patients formed the non circuit group (NCG)

Outcomes

Primary Outcome Measures

walked in meters in the six minute walking test (6MWT)
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

Secondary Outcome Measures

Full Information

First Posted
May 12, 2013
Last Updated
May 12, 2013
Sponsor
Hospital de Mataró
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1. Study Identification

Unique Protocol Identification Number
NCT01854008
Brief Title
Urban Walking Circuits
Official Title
Improving Physical Activity in Patients With Severe Chronic Obstructive Pulmonary Disease With Urban Walking Circuits
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital de Mataró

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Chronic Obstructive Pulmonary Disease
Keywords
Exercise, Physical activity, Rehabilitation, COPD.

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
82 (Actual)

8. Arms, Groups, and Interventions

Arm Title
rehabilitation program more the urban circuit
Arm Type
Experimental
Arm Description
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
Arm Title
rehabilitation program non circuit group .
Arm Type
Experimental
Arm Description
One group, the urban circuit group (UCG), received a triptych that included urban walking circuits,the remaining patients formed the non circuit group (NCG)
Intervention Type
Other
Intervention Name(s)
rehabilitation more the urban circuit
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
rehabilitation program but not given urbane circuits
Intervention Description
Only rehabilitation program and general recommendations on physical activity and lifestyle . No urbans circuits.
Primary Outcome Measure Information:
Title
walked in meters in the six minute walking test (6MWT)
Description
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
Time Frame
Unlike walking meters of baseline and one year

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Facility Information:
Facility Name
Eulogio Pleguezuelos
City
Mataro
State/Province
Barcelona
ZIP/Postal Code
08304
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
23890958
Citation
Pleguezuelos E, Perez ME, Guirao L, Samitier B, Ortega P, Vila X, Solans M, Riera A, Moreno E, Meri A, Miravitlles M. Improving physical activity in patients with COPD with urban walking circuits. Respir Med. 2013 Dec;107(12):1948-56. doi: 10.1016/j.rmed.2013.07.008. Epub 2013 Jul 23.
Results Reference
derived
Links:
URL
http://www.csdm.cat
Description
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