NCT01649193

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 9, 2012

Completed
16 days until next milestone

First Posted

Study publicly available on registry

July 25, 2012

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

November 5, 2014

Status Verified

November 1, 2014

Enrollment Period

1.9 years

First QC Date

July 9, 2012

Last Update Submit

November 4, 2014

Conditions

Respiratory Tract DiseasesLung Diseases

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • Change from baseline of Short Physical Performance Battery

    8 weeks

Secondary Outcomes (3)

  • Change from baseline of MRC Dyspnoea Scale

    8 weeks

  • Change from baseline of St George's Respiratory Questionaire

    8 weeks

  • Anchor question (5-point Likert scale)

    8 weeks

Study Arms (1)

Chronic Respiratory Disease

Any patient with a chronic respiratory disease referred for pulmonary rehabilitation

Other: Pulmonary rehabilitation

Interventions

Pulmonary rehabilitationOTHER

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

Chronic Respiratory Disease

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All chronic respiratory disease patients referred for pulmonary rehabilitation.

You may qualify if:

  • All patients entering pulmonary rehabilitation

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Harefield Hospital

Harefield, Middlesex, UB9 6JH, United Kingdom

Location

Related Publications (4)

  • 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.

    PMID: 1494764BACKGROUND

  • 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.

    PMID: 1595997BACKGROUND

  • 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.

    PMID: 7838189BACKGROUND

  • 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.

    PMID: 28476882DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Respiratory Tract DiseasesLung Diseases

Study Officials

  • William DC Man, MRCP, PhD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2012

First Posted

July 25, 2012

Study Start

March 1, 2012

Primary Completion

February 1, 2014

Study Completion

May 1, 2014

Last Updated

November 5, 2014

Record last verified: 2014-11

Locations

GB(1)