Is the Short Physical Performance Battery a Useful Outcome Measure in Chronic Obstructive Pulmonary Disease
This study is currently recruiting participants.
Verified January 2012 by Royal Brompton & Harefield NHS Foundation Trust
Sponsor:
Royal Brompton & Harefield NHS Foundation Trust
Collaborator:
Medical Research Council
Information provided by (Responsible Party):
Royal Brompton & Harefield NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01515709
First received: January 10, 2012
Last updated: January 18, 2012
Last verified: January 2012
| Tracking Information | |||||||||
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| First Received Date ICMJE | January 10, 2012 | ||||||||
| Last Updated Date | January 18, 2012 | ||||||||
| Start Date ICMJE | April 2011 | ||||||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Mortality rate [ Time Frame: 36 months ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01515709 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Is the Short Physical Performance Battery a Useful Outcome Measure in Chronic Obstructive Pulmonary Disease | ||||||||
| Official Title ICMJE | Is the Short Physical Performance Battery a Useful Outcome Measure in Patients With Chronic Obstructive Pulmonary Disease ? | ||||||||
| Brief Summary | Patients with Chronic Obstructive Lung Disease (COPD) often develop muscle problems, particularly in their legs which makes them more limited in what they can do. The Short Physical Performance Battery (SPPB) is a simple test of standing balance, usual walking speed and ability to stand from a chair. The SPPB may be a useful measure to predict leg function. This study aims to evaluate whether the SPPB is comparable with current exercise tests used in COPD patients, and whether it is useful in predicting disability, death and health resource usage over time. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Any patient with a diagnosis of COPD. |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) | Chronic Obstructive Pulmonary Disease
Patients with a diagnosis of COPD |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 400 | ||||||||
| Estimated Completion Date | December 2015 | ||||||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | Not Provided | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United Kingdom | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01515709 | ||||||||
| Other Study ID Numbers ICMJE | 2011LF001H | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Royal Brompton & Harefield NHS Foundation Trust | ||||||||
| Study Sponsor ICMJE | Royal Brompton & Harefield NHS Foundation Trust | ||||||||
| Collaborators ICMJE | Medical Research Council | ||||||||
| Investigators ICMJE |
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| Information Provided By | Royal Brompton & Harefield NHS Foundation Trust | ||||||||
| Verification Date | January 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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