Clinical trial NCT01649193: What is an Important Change in the Short Physical Performance Battery (SPPB)?
Official title: Determining the Minimal Important Difference of the Short Physical Performance Battery and 4m Gait Speed in Chronic Respiratory Disease Patients.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Tract Diseases
Lung Diseases
Keywords: Rehabilitation [E02.831]
Exercise [G11.427.394.380]
Health Education [I02.233.332]
[C08]
[C08.381]
Lead sponsor: Royal Brompton & Harefield NHS Foundation Trust
Sponsor class: OTHER
First posted: 2012-07-25
Enrollment: 400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All chronic respiratory disease patients referred for pulmonary rehabilitation.

Brief summary: 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.


Eligibility 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).

Primary outcomes:
measure: Change from baseline of Short Physical Performance Battery
timeFrame: 8 weeks
Secondary outcomes:
measure: Change from baseline of MRC Dyspnoea Scale
timeFrame: 8 weeks
measure: Change from baseline of St George's Respiratory Questionaire
timeFrame: 8 weeks
measure: Anchor question (5-point Likert scale)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Harefield
country: United Kingdom
facility: Harefield Hospital
state: Middlesex
Study officials:
affiliation: Repiratory Biomedical Reserach Unit, Royal Brompton & Harefield NHS Foundation Trust and Imperial College London
name: William DC Man, MRCP, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1136/thx.47.12.1019.
citation: 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. doi: 10.1164/ajrccm/145.6.1321.
citation: 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.
citation: 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.