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

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ClinicalTrials.gov Identifier: NCT01649193
Recruitment Status : Completed
First Posted : July 25, 2012
Last Update Posted : November 5, 2014
Sponsor:
Information provided by (Responsible Party):
Royal Brompton & Harefield NHS Foundation Trust

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.

Condition or disease Intervention/treatment
Respiratory Tract Diseases Lung Diseases Other: Pulmonary rehabilitation

Study Type : Observational
Actual Enrollment : 400 participants
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.
Study Start Date : March 2012
Actual Primary Completion Date : February 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
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



Primary Outcome Measures :
  1. Change from baseline of Short Physical Performance Battery [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Change from baseline of MRC Dyspnoea Scale [ Time Frame: 8 weeks ]
  2. Change from baseline of St George's Respiratory Questionaire [ Time Frame: 8 weeks ]
  3. Anchor question (5-point Likert scale) [ Time Frame: 8 weeks ]

Biospecimen Retention:   Samples With DNA
Blood taken and stored as whole blood, serum, and plasma.


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01649193


Locations
United Kingdom
Harefield Hospital
Harefield, Middlesex, United Kingdom, UB9 6JH
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

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Royal Brompton & Harefield NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01649193     History of Changes
Other Study ID Numbers: 2012LF001H
First Posted: July 25, 2012    Key Record Dates
Last Update Posted: November 5, 2014
Last Verified: November 2014

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