NCT01854008

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

May 12, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 15, 2013

Completed
Last Updated

May 15, 2013

Status Verified

May 1, 2013

Enrollment Period

3.2 years

First QC Date

May 12, 2013

Last Update Submit

May 12, 2013

Conditions

Keywords

Exercise, Physical activity, Rehabilitation, COPD.

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

rehabilitation program more the urban circuit

EXPERIMENTAL

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

Other: rehabilitation more the urban circuit

rehabilitation program non circuit group .

EXPERIMENTAL

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

Other: rehabilitation program but not given urbane circuits

Interventions

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 more the urban circuit

Only rehabilitation program and general recommendations on physical activity and lifestyle . No urbans circuits.

rehabilitation program non circuit group .

Eligibility Criteria

Age50 Years - 85 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eulogio Pleguezuelos

Mataró, Barcelona, 08304, Spain

Location

Related Publications (1)

  • 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.

Related Links

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveMotor Activity

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

May 12, 2013

First Posted

May 15, 2013

Study Start

April 1, 2008

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

May 15, 2013

Record last verified: 2013-05

Locations