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

Lung Diseases Clinical Trial

Official title:

Determining the Minimal Important Difference of the Short Physical Performance Battery and 4m Gait Speed in Chronic Respiratory Disease Patients.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01649193
• Other study ID #: 2012LF001H
• Status: Completed
• Phase: N/A
• First received: July 9, 2012
• Last updated: November 4, 2014
• Start date: March 2012
• Est. completion date: May 2014

Study information

• Verified date: November 2014
• Source: Royal Brompton & Harefield NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Institute for Health ResearchUnited Kingdom: Research Ethics CommitteeUnited Kingdom: Department of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: May 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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).

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Lung Diseases
• Respiratory Tract Diseases

Intervention

Other:
• Pulmonary rehabilitation
An eight week out-patient based programme consisting of twice weekly supervised exercise and educational sessions

Locations

Country	Name	City	State
United Kingdom	Harefield Hospital	Harefield	Middlesex

Sponsors (1)

Lead Sponsor	Collaborator
Royal Brompton & Harefield NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

References & 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline of Short Physical Performance Battery		8 weeks	No
Secondary	Change from baseline of MRC Dyspnoea Scale		8 weeks	No
Secondary	Change from baseline of St George's Respiratory Questionaire		8 weeks	No
Secondary	Anchor question (5-point Likert scale)		8 weeks	No