NCT01507415

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
226

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2011

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 6, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 10, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

November 5, 2014

Status Verified

November 1, 2014

Enrollment Period

1.3 years

First QC Date

January 6, 2012

Last Update Submit

November 4, 2014

Conditions

Pulmonary Disease, Chronic ObstructiveRespiratory Tract DiseasesLung DiseasesLung Diseases, ObstructiveBronchitis, ChronicPulmonary EmphysemaDisease Progression

Keywords

Cohort StudiesLongitudinal StudiesPatient ReadmissionHospitalizationDisability Evaluation

Outcome Measures

Primary Outcomes (1)

  • Hospital readmission rate

    3 months

Secondary Outcomes (3)

  • Hospital readmission rate

    12 months

  • Time to first hospital readmission

    12 months

  • Hospital Bed days

    12 months

Study Arms (1)

Exacerbation

Patients with Chronic Obstructive Pulmonary Disease (COPD)

Eligibility Criteria

Age35 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Hospital admission with an exacerbation of COPD
  • Must have capacity to consent
  • Able to walk

You may not qualify if:

  • Co-morbibities that limit walking ability
  • Co-morbidities that make walking unsafe

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hillingdon Hospital

Uxbridge, UB8 3NN, United Kingdom

Location

Watford General Hospital

Watford, WD18 0HB, United Kingdom

Location

Related Publications (3)

  • 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.

    PMID: 20861145BACKGROUND

  • Nolan 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.

    PMID: 28476882DERIVED

  • Kon 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.

    PMID: 26283709DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, plasma and serum.

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveRespiratory Tract DiseasesLung DiseasesLung Diseases, ObstructiveBronchitis, ChronicPulmonary EmphysemaDisease Progression

Condition Hierarchy (Ancestors)

Chronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBronchitisRespiratory Tract InfectionsInfectionsBronchial Diseases

Study Officials

  • William DC Man, MRCP PhD

    NIHR Respiratory Biomedical Research Unit, Royal Brompton & Harefield NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2012

First Posted

January 10, 2012

Study Start

November 1, 2011

Primary Completion

February 1, 2013

Study Completion

February 1, 2014

Last Updated

November 5, 2014

Record last verified: 2014-11

Locations

GB(2)