NCT01515709

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
445

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

April 1, 2011

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 10, 2012

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 24, 2012

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

October 3, 2018

Status Verified

October 1, 2018

Enrollment Period

2.4 years

First QC Date

January 10, 2012

Last Update Submit

October 2, 2018

Conditions

Keywords

Cohort StudiesLongitudinal Studies

Outcome Measures

Primary Outcomes (1)

  • Mortality rate

    36 months

Secondary Outcomes (2)

  • Hospitalisation rate

    36 months

  • Healthcare resource usage

    36 months

Study Arms (1)

Chronic Obstructive Pulmonary Disease

Patients with a diagnosis of COPD

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Any patient with a diagnosis of COPD.

You may qualify if:

  • Diagnosis of COPD

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Harefield Hospital

Harefield, UB9 6JH, United Kingdom

Location

Related Publications (3)

  • 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.

    PMID: 7838189BACKGROUND
  • Guralnik 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.

    PMID: 8126356BACKGROUND
  • 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.

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveLung Diseases, ObstructivePulmonary EmphysemaBronchitis, ChronicLung DiseasesDisease Progression

Condition Hierarchy (Ancestors)

Respiratory Tract DiseasesChronic 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 10, 2012

First Posted

January 24, 2012

Study Start

April 1, 2011

Primary Completion

September 1, 2013

Study Completion

September 1, 2018

Last Updated

October 3, 2018

Record last verified: 2018-10

Locations