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OpenTrials
Completed

NCT Number: NCT01649193

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

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Harefield Hospital

Harefield, Middlesex, UB9 6JH, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Pulmonary Rehabilitation

Other

An eight week out-patient based programme consisting of twice weekly supervised exercise and educational sessions

Primary outcomes

  1. Change from baseline of Short Physical Performance Battery

    Time frame: 8 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Royal Brompton & Harefield NHS Foundation Trust

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jul 25, 2012
Registry last updated
Nov 5, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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