Trial record 10 of 3740 for:
"Lung Diseases, Obstructive"
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
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Purpose
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.
| Condition |
|---|
|
Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Pulmonary Emphysema Bronchitis, Chronic Lung Diseases Disease Progression |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Is the Short Physical Performance Battery a Useful Outcome Measure in Patients With Chronic Obstructive Pulmonary Disease ? |
Resource links provided by NLM:
MedlinePlus related topics:
COPD (Chronic Obstructive Pulmonary Disease)
Chronic Bronchitis
Emphysema
U.S. FDA Resources
Further study details as provided by Royal Brompton & Harefield NHS Foundation Trust:
Primary Outcome Measures:
- Mortality rate [ Time Frame: 36 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Hospitalisation rate [ Time Frame: 36 months ] [ Designated as safety issue: No ]
- Healthcare resource usage [ Time Frame: 36 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 400 |
| Study Start Date: | April 2011 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Chronic Obstructive Pulmonary Disease
Patients with a diagnosis of COPD
|
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Any patient with a diagnosis of COPD.
Criteria
Inclusion Criteria:
- Diagnosis of COPD
Exclusion Criteria:
- Any patient in whom mobility and lower limb function have been significantly affected by a neuromuscular cause (eg. motor neurone disease), severe peripheral vascular disease or amputation
- Any patient whom is deemed unsafe to exercise
- Patients unable to complete the SPPB, walking tests and leg strength assessments.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01515709
Contacts
| Contact: Samantha SC Kon, BSc MRCP | 01895 823 737 ext 5021 | lungresearch@rbht.nhs.uk |
| Contact: Jane L Canavan, PhD | 01895 823 737 ext 5021 | lungresearch@rbht.nhs.uk |
Locations
| United Kingdom | |
| Harefield Hospital | Recruiting |
| Harefield, United Kingdom, UB9 6JH | |
| Contact: Samantha SC Kon, BSc MRCP 01895 823 737 ext 5021 lungresearch@rbht.nhs.uk | |
| Contact: Jane L Canavan, PhD 01895 823 737 ext 5021 lungresearch@rbht.nhs.uk | |
Sponsors and Collaborators
Royal Brompton & Harefield NHS Foundation Trust
Medical Research Council
Investigators
| Principal Investigator: | William DC Man, MRCP PhD | NIHR Respiratory Biomedical Research Unit, Royal Brompton & Harefield NHS Foundation Trust |
More Information
Publications:
| Responsible Party: | Royal Brompton & Harefield NHS Foundation Trust |
| ClinicalTrials.gov Identifier: | NCT01515709 History of Changes |
| Other Study ID Numbers: | 2011LF001H |
| Study First Received: | January 10, 2012 |
| Last Updated: | January 18, 2012 |
| Health Authority: | United Kingdom: Research Ethics Committee United Kingdom: National Institute for Health Research United Kingdom: National Health Service |
Keywords provided by Royal Brompton & Harefield NHS Foundation Trust:
|
Cohort Studies Longitudinal Studies |
Additional relevant MeSH terms:
|
Lung Diseases, Obstructive Bronchitis Bronchitis, Chronic Chronic Disease Emphysema Pulmonary Emphysema Lung Diseases Respiration Disorders |
Pulmonary Disease, Chronic Obstructive Disease Progression Bronchial Diseases Respiratory Tract Diseases Respiratory Tract Infections Disease Attributes Pathologic Processes |
ClinicalTrials.gov processed this record on June 13, 2013