Pulmonary Disease, Chronic ObstructiveNCT01515709
Is the Short Physical Performance Battery a Useful Outcome Measure in Chronic Obstructive Pulmonary Disease
An observational study of Pulmonary Disease, Chronic Obstructive and Lung Diseases, Obstructive, run by Royal Brompton & Harefield NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive, Lung Diseases, Obstructive, Pulmonary Emphysema
- How many people
- 445 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2011to Sep 2018
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Any patient with a diagnosis of COPD.
Who may be able to join
- Diagnosis of COPD
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is the Short Physical Performance Battery a Useful Outcome Measure in Patients With Chronic Obstructive Pulmonary Disease ?
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.
- Conditions
- Pulmonary Disease, Chronic Obstructive, Lung Diseases, Obstructive, Pulmonary Emphysema, Bronchitis, Chronic, Lung Diseases, Disease Progression
- Keywords
- Cohort Studies, Longitudinal Studies
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Lung Diseases, Obstructive, Pulmonary Emphysema, Bronchitis, Chronic, Lung Diseases, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Chronic Obstructive Pulmonary Disease | Patients with a diagnosis of COPD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality rate
Measured: 36 months
Secondary outcomes (2)
Hospitalisation rate
Measured: 36 months
Healthcare resource usage
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2012 (estimated)
- Study startApr 2011
- Primary completionSep 2013
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 445 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Council
- Responsible party
- Sponsor
- Investigators
- William DC Man, MRCP PhD, Principal investigator, NIHR Respiratory Biomedical Research Unit, Royal Brompton & Harefield NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01515709
- Sponsor's protocol ID
- 2011LF001H
- Status last verified
- Oct 2018
- First submitted
- 10 Jan 2012
- Last updated
- 3 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Guralnik JM, Ferrucci L, Simonsick EM, Salive ME, Wallace RB. Lower-extremity function in persons over the age of 70 years as a predictor of subsequent disability. N Engl J Med. 1995 Mar 2;332(9):556-61. doi: 10.1056/NEJM199503023320902.
PubMed 7838189Guralnik JM, Simonsick EM, Ferrucci L, Glynn RJ, Berkman LF, Blazer DG, Scherr PA, Wallace RB. A short physical performance battery assessing lower extremity function: association with self-reported disability and prediction of mortality and nursing home admission. J Gerontol. 1994 Mar;49(2):M85-94. doi: 10.1093/geronj/49.2.m85.
PubMed 8126356Nolan CM, Kon SSC, Patel S, Jones SE, Barker RE, Polkey MI, Maddocks M, Man WD. Gait speed and pedestrian crossings in COPD. Thorax. 2018 Feb;73(2):191-192. doi: 10.1136/thoraxjnl-2017-210173. Epub 2017 May 5.
PubMed 28476882
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is the Short Physical Performance Battery a Useful Outcome Measure in Patients With Chronic Obstructive Pulmonary Disease ?
- ClinicalTrials.gov ID
- NCT01515709
- Acronym / sponsor ID
- 2011LF001H
- Conditions
- Pulmonary Disease, Chronic Obstructive, Lung Diseases, Obstructive, Pulmonary Emphysema, Bronchitis, Chronic, Lung Diseases, Disease Progression
- Keywords
- Cohort Studies, Longitudinal Studies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 445 participants (actual)
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Medical Research Council
- Study start
- Apr 2011 (actual)
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 24 Jan 2012 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic Obstructive Pulmonary Disease | – | –Patients with a diagnosis of COPD |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Any patient with a diagnosis of COPD.
Key inclusion criteria (1 listed)
- Diagnosis of COPD
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mortality rate
Time frame: 36 months
2 secondary outcomes
Hospitalisation rate
Time frame: 36 months
Healthcare resource usage
Time frame: 36 months
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 3 Oct 2018.
- Background: PubMed 7838189Guralnik JM, Ferrucci L, Simonsick EM, Salive ME, Wallace RB. Lower-extremity function in persons over the age of 70 years as a predictor of subsequent disability. N Engl J Med. 1995 Mar 2;332(9):556-61. doi: 10.1056/NEJM199503023320902.
- Background: PubMed 8126356Guralnik JM, Simonsick EM, Ferrucci L, Glynn RJ, Berkman LF, Blazer DG, Scherr PA, Wallace RB. A short physical performance battery assessing lower extremity function: association with self-reported disability and prediction of mortality and nursing home admission. J Gerontol. 1994 Mar;49(2):M85-94. doi: 10.1093/geronj/49.2.m85.
- Derived from this study: PubMed 28476882Nolan CM, Kon SSC, Patel S, Jones SE, Barker RE, Polkey MI, Maddocks M, Man WD. Gait speed and pedestrian crossings in COPD. Thorax. 2018 Feb;73(2):191-192. doi: 10.1136/thoraxjnl-2017-210173. Epub 2017 May 5.
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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.
William DC Man, MRCP PhD principal investigator
NIHR Respiratory Biomedical Research Unit, Royal Brompton & Harefield NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Disease, Chronic Obstructive and Lung Diseases, Obstructive, run by Royal Brompton & Harefield NHS Foundation Trust at 1 site in United Kingdom.
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 3 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 3 Oct 2018. 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 United Kingdom. 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?
Mortality rate (time frame: 36 months). 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 NCT01515709, which also lists 3 linked publications.
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 3 Oct 2018.