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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01854008
Other study ID # WALURB-01
Secondary ID
Status Completed
Phase N/A
First received May 12, 2013
Last updated May 12, 2013
Start date April 2008
Est. completion date June 2011

Study information

Verified date May 2013
Source Hospital de Mataró
Contact n/a
Is FDA regulated No
Health authority Spain: Ethics Committee
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 82
Est. completion date June 2011
Est. primary completion date June 2011
Accepts healthy volunteers No
Gender Male
Age group 50 Years to 85 Years
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
rehabilitation more the urban circuit
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
rehabilitation program but not given urbane circuits
Only rehabilitation program and general recommendations on physical activity and lifestyle . No urbans circuits.

Locations

Country Name City State
Spain Eulogio Pleguezuelos Mataro Barcelona

Sponsors (1)

Lead Sponsor Collaborator
Hospital de Mataró

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Unlike walking meters of baseline and one year No
See also
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Not yet recruiting NCT06252805 - Severe Prospective Observational COPD Catalonia
Completed NCT05199987 - Breathing Control Exercises in Patients With Chronic Obstructive Pulmonary Disease. N/A
Completed NCT05222295 - The Effectiveness Pulmonary Telerehabilitation and Cognitive Telerehabilitation in COPD Patients N/A
Completed NCT02103374 - Evaluation of Benefit of Nebulized Bronchodilators at Home in Severe Chronic Obstructive Pulmonary Disease and Very Severe Steady State Phase 4

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