Pulmonary Disease, Chronic ObstructiveNCT01507415
Do the SPPB and 4-metre Gait Speed Predict Hospital Readmission in Patients Hospitalised for Acute Exacerbation if COPD?
An observational study of Pulmonary Disease, Chronic Obstructive and Respiratory Tract Diseases, run by Royal Brompton & Harefield NHS Foundation Trust at 2 sites in United Kingdom.
Trial summary
This study aims to evaluate simple tests of physical function in hospitalised patients with chronic obstructive pulmonary disease (COPD) and to assess whether they can predict future hospital readmission. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive, Respiratory Tract Diseases, Lung Diseases
- How many people
- 226 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Nov 2011to Feb 2014
- 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 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Any patient hospitalised with an acute exacerbation of COPD. Cohorts will be recruited from local District General Hospitals with Acute Admissions Units and Accident \& Emergency Departments.
Who may be able to join
- Hospital admission with an exacerbation of COPD
- Must have capacity to consent
- Able to walk
Who cannot join
- Co-morbibities that limit walking ability
- Co-morbidities that make walking unsafe
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Hillingdon Hospital
Uxbridge, UB8 3NN
Watford General Hospital
Watford, WD18 0HB
About this study
This study aims to evaluate simple tests of physical function in hospitalised patients with chronic obstructive pulmonary disease (COPD) and to assess whether they can predict future hospital readmission. The Short Physical Performance Battery (SPPB) is a simple test of standing balance, usual walking speed (4-metre gait speed) and ability to stand from a chair, which reflects global physical functioning and frailty.
We hypothesise that the SPPB or 4-metre gait speed can predict future hospital readmissions.
- Conditions
- Pulmonary Disease, Chronic Obstructive, Respiratory Tract Diseases, Lung Diseases, Lung Diseases, Obstructive, Bronchitis, Chronic, Pulmonary Emphysema
- Keywords
- Cohort Studies, Longitudinal Studies, Patient Readmission, Hospitalization, Disability Evaluation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Respiratory Tract Diseases, Lung Diseases, Lung Diseases, Obstructive, Bronchitis, Chronic, Pulmonary Emphysema, 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 |
|---|---|---|
| Exacerbation | Patients with Chronic Obstructive Pulmonary Disease (COPD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital readmission rate
Measured: 3 months
Secondary outcomes (3)
Hospital readmission rate
Measured: 12 months
Time to first hospital readmission
Measured: 12 months
Hospital Bed days
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2012 (estimated)
- Study startNov 2011
- Primary completionFeb 2013
- Study completionFeb 2014
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
- 226 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Council, The Hillingdon Hospitals NHS Foundation Trust, West Hertfordshire Hospitals NHS Trust
- 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
- NCT01507415
- Sponsor's protocol ID
- 2011LF015H
- Status last verified
- Nov 2014
- First submitted
- 6 Jan 2012
- Last updated
- 5 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Volpato S, Cavalieri M, Sioulis F, Guerra G, Maraldi C, Zuliani G, Fellin R, Guralnik JM. Predictive value of the Short Physical Performance Battery following hospitalization in older patients. J Gerontol A Biol Sci Med Sci. 2011 Jan;66(1):89-96. doi: 10.1093/gerona/glq167. Epub 2010 Sep 22.
PubMed 20861145Nolan 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 28476882Kon SS, Jones SE, Schofield SJ, Banya W, Dickson MJ, Canavan JL, Nolan CM, Haselden BM, Polkey MI, Cullinan P, Man WD. Gait speed and readmission following hospitalisation for acute exacerbations of COPD: a prospective study. Thorax. 2015 Dec;70(12):1131-7. doi: 10.1136/thoraxjnl-2015-207046. Epub 2015 Aug 17.
PubMed 26283709
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do the SPPB and 4-metre Gait Speed Predict Hospital Readmission in Patients Hospitalised for Acute Exacerbation if COPD?
- ClinicalTrials.gov ID
- NCT01507415
- Acronym / sponsor ID
- 2011LF015H
- Conditions
- Pulmonary Disease, Chronic Obstructive, Respiratory Tract Diseases, Lung Diseases, Lung Diseases, Obstructive, Bronchitis, Chronic, Pulmonary Emphysema
- Keywords
- Cohort Studies, Longitudinal Studies, Patient Readmission, Hospitalization, Disability Evaluation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 226 participants (actual)
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Medical Research Council, The Hillingdon Hospitals NHS Foundation Trust, West Hertfordshire Hospitals NHS Trust
- Study start
- Nov 2011
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 10 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.
This study aims to evaluate simple tests of physical function in hospitalised patients with chronic obstructive pulmonary disease (COPD) and to assess whether they can predict future hospital readmission. The Short Physical Performance Battery (SPPB) is a simple test of standing balance, usual walking speed (4-metre gait speed) and ability to stand from a chair, which reflects global physical functioning and frailty.
We hypothesise that the SPPB or 4-metre gait speed can predict future hospital readmissions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exacerbation | – | –Patients with Chronic Obstructive Pulmonary Disease (COPD) |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any patient hospitalised with an acute exacerbation of COPD. Cohorts will be recruited from local District General Hospitals with Acute Admissions Units and Accident \& Emergency Departments.
Key inclusion criteria (3 listed)
- Hospital admission with an exacerbation of COPD
- Must have capacity to consent
- Able to walk
Key exclusion criteria (2 listed)
- Co-morbibities that limit walking ability
- Co-morbidities that make walking unsafe
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
Hospital readmission rate
Time frame: 3 months
3 secondary outcomes
Hospital readmission rate
Time frame: 12 months
Time to first hospital readmission
Time frame: 12 months
Hospital Bed days
Time frame: 12 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 5 Nov 2014.
- Background: PubMed 20861145Volpato S, Cavalieri M, Sioulis F, Guerra G, Maraldi C, Zuliani G, Fellin R, Guralnik JM. Predictive value of the Short Physical Performance Battery following hospitalization in older patients. J Gerontol A Biol Sci Med Sci. 2011 Jan;66(1):89-96. doi: 10.1093/gerona/glq167. Epub 2010 Sep 22.
- 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.
- Derived from this study: PubMed 26283709Kon SS, Jones SE, Schofield SJ, Banya W, Dickson MJ, Canavan JL, Nolan CM, Haselden BM, Polkey MI, Cullinan P, Man WD. Gait speed and readmission following hospitalisation for acute exacerbations of COPD: a prospective study. Thorax. 2015 Dec;70(12):1131-7. doi: 10.1136/thoraxjnl-2015-207046. Epub 2015 Aug 17.
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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
2 sites 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 Respiratory Tract Diseases, run by Royal Brompton & Harefield NHS Foundation Trust at 2 sites 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 3 inclusion and 2 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 5 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Hospital readmission rate (time frame: 3 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 NCT01507415, 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 5 Nov 2014.