What is an Important Change in the Short Physical Performance Battery (SPPB)?

This study is currently recruiting participants.

Verified October 2012 by Royal Brompton & Harefield NHS Foundation Trust

Sponsor:

Information provided by (Responsible Party):

Royal Brompton & Harefield NHS Foundation Trust

ClinicalTrials.gov Identifier:

NCT01649193

First received: July 9, 2012

Last updated: October 30, 2012

Last verified: October 2012

History of Changes

Purpose

The purpose of this study is to determine the important change in the Short Physical Performance Battery (SPPB) when used in patients with lung disease. The SPPB is a simple physical test that measures balance and the functioning of the legs. It has been widely used in healthy elderly populations and predicts hospital admission and the onset of disability. The SPPB has not previously been used in patients with lung disease, and it is not clear what change in this test is considered meaningful and worthwhile by patients or doctors (the minimal clinically important difference: MID). Knowing what the MID for the SPPB will allow researchers and doctors to evaluate the effectiveness of current and new treatments, and to detect improvement or deterioration in the condition of patients.

Condition	Intervention
Respiratory Tract Diseases Lung Diseases	Other: Pulmonary rehabilitation

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Determining the Minimal Important Difference of the Short Physical Performance Battery and 4m Gait Speed in Chronic Respiratory Disease Patients.

Resource links provided by NLM:

MedlinePlus related topics: Rehabilitation

U.S. FDA Resources

Further study details as provided by Royal Brompton & Harefield NHS Foundation Trust:

Primary Outcome Measures:

Change from baseline of Short Physical Performance Battery [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline of MRC Dyspnoea Scale [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Change from baseline of St George's Respiratory Questionaire [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Anchor question (5-point Likert scale) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples With DNA

Blood taken and stored as whole blood, serum, and plasma.

Estimated Enrollment:	300
Study Start Date:	March 2012
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	September 2013 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Chronic Respiratory Disease Any patient with a chronic respiratory disease referred for pulmonary rehabilitation	Other: Pulmonary rehabilitation An eight week out-patient based programme consisting of twice weekly supervised exercise and educational sessions

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

All chronic respiratory disease patients referred for pulmonary rehabilitation.

Criteria

Inclusion Criteria:

All patients entering pulmonary rehabilitation

Exclusion Criteria:

Any patient in whom mobility and lower limb function have been significantly affected by a neuromuscular cause, severe peripheral vascular disease or amputation.
Any patient whom the chief investigator feels it is unsafe to exercise (e.g. unstable cardiac disease).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01649193

Locations

United Kingdom
Harefield Hospital	Recruiting
Harefield, Middlesex, United Kingdom, UB9 6JH
Contact: William DC Man, MRCP, PhD 01895 823 737 ext 5851 w.man@rbht.nhs.uk
Contact: Samantha SC Kon, BSc, MRCP 01895 823 737 ext 5021 lungresearch@rbht.nhs.uk
Principal Investigator: William DC Man, MRCP, PhD

Sponsors and Collaborators

Royal Brompton & Harefield NHS Foundation Trust

Investigators

Principal Investigator:

William DC Man, MRCP, PhD

Repiratory Biomedical Reserach Unit, Royal Brompton & Harefield NHS Foundation Trust and Imperial College London

More Information

Publications:

Singh SJ, Morgan MD, Scott S, Walters D, Hardman AE. Development of a shuttle walking test of disability in patients with chronic airways obstruction. Thorax. 1992 Dec;47(12):1019-24.

Jones PW, Quirk FH, Baveystock CM, Littlejohns P. A self-complete measure of health status for chronic airflow limitation. The St. George's Respiratory Questionnaire. Am Rev Respir Dis. 1992 Jun;145(6):1321-7.

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.

Responsible Party:	Royal Brompton & Harefield NHS Foundation Trust
ClinicalTrials.gov Identifier:	NCT01649193 History of Changes
Other Study ID Numbers:	2012LF001H
Study First Received:	July 9, 2012
Last Updated:	October 30, 2012
Health Authority:	United Kingdom: National Institute for Health Research United Kingdom: Research Ethics Committee United Kingdom: Department of Health

Keywords provided by Royal Brompton & Harefield NHS Foundation Trust:

Rehabilitation [E02.831]
Exercise [G11.427.394.380]
Health Education [I02.233.332]
[C08]
[C08.381]

Additional relevant MeSH terms:

Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 21, 2013

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