Severe Chronic Obstructive Pulmonary DiseaseNCT01854008
Urban Walking Circuits
A study testing rehabilitation more the urban circuit and rehabilitation program but not given urbane circuits in people with Severe Chronic Obstructive Pulmonary Disease, run by Hospital de Mataró at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 50 to 85 years, men only
- Conditions the study is for
- Severe Chronic Obstructive Pulmonary Disease
- What is being tested?
- rehabilitation more the urban circuit and rehabilitation program but not given urbane circuits
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteSpain
- Study dates
- Apr 2008to Jun 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- rehabilitation more the urban circuit, rehabilitation program but not given urbane circuits
- Keywords
- Exercise, Physical activity, Rehabilitation, COPD.
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rehabilitation more the urban circuitOther
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 circuitsOther
Only rehabilitation program and general recommendations on physical activity and lifestyle . No urbans circuits.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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) Receives: Other: rehabilitation program but not given urbane circuits |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Unlike walking meters of baseline and one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2013 (estimated)
- Study startApr 2008
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Severe Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Mataró
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eulogio Pleguezuelos, Hospital de Mataró
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01854008
- Sponsor's protocol ID
- WALURB-01
- Status last verified
- May 2013
- First submitted
- 12 May 2013
- Last updated
- 15 May 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23890958
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Physical Activity in Patients With Severe Chronic Obstructive Pulmonary Disease With Urban Walking Circuits
- ClinicalTrials.gov ID
- NCT01854008
- Acronym / sponsor ID
- WALURB-01
- Keywords
- Exercise, Physical activity, Rehabilitation, COPD.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Hospital de MataróUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 15 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rehabilitation program more the urban circuit | Experimental | Other: rehabilitation more the urban circuitOne 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 |
| rehabilitation program non circuit group . | Experimental | Other: rehabilitation program but not given urbane circuitsOne group, the urban circuit group (UCG), received a triptych that included urban walking circuits,the remaining patients formed the non circuit group (NCG) |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rehabilitation more the urban circuitincluded 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 | Other | rehabilitation program more the urban circuit |
| rehabilitation program but not given urbane circuitsOnly rehabilitation program and general recommendations on physical activity and lifestyle . No urbans circuits. | Other | rehabilitation program non circuit group . |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2013.
- Derived from this study: PubMed 23890958Pleguezuelos 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 InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rehabilitation more the urban circuit and rehabilitation program but not given urbane circuits in people with Severe Chronic Obstructive Pulmonary Disease, run by Hospital de Mataró at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
walked in meters in the six minute walking test (6MWT) (time frame: Unlike walking meters of baseline and one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01854008, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2013.