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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01515709
Other study ID # 2011LF001H
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 2011
Est. completion date September 2018

Study information

Verified date October 2018
Source Royal Brompton & Harefield NHS Foundation Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Patients with Chronic Obstructive Lung Disease (COPD) often develop muscle problems, particularly in their legs which makes them more limited in what they can do. The Short Physical Performance Battery (SPPB) is a simple test of standing balance, usual walking speed and ability to stand from a chair. The SPPB may be a useful measure to predict leg function.

This study aims to evaluate whether the SPPB is comparable with current exercise tests used in COPD patients, and whether it is useful in predicting disability, death and health resource usage over time.


Recruitment information / eligibility

Status Completed
Enrollment 445
Est. completion date September 2018
Est. primary completion date September 2013
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Diagnosis of COPD

Exclusion Criteria:

- Any patient in whom mobility and lower limb function have been significantly affected by a neuromuscular cause (eg. motor neurone disease), severe peripheral vascular disease or amputation

- Any patient whom is deemed unsafe to exercise

- Patients unable to complete the SPPB, walking tests and leg strength assessments.

Study Design


Locations

Country Name City State
United Kingdom Harefield Hospital Harefield

Sponsors (2)

Lead Sponsor Collaborator
Royal Brompton & Harefield NHS Foundation Trust Medical Research Council

Country where clinical trial is conducted

United Kingdom, 

References & Publications (2)

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

Guralnik JM, Simonsick EM, Ferrucci L, Glynn RJ, Berkman LF, Blazer DG, Scherr PA, Wallace RB. A short physical performance battery assessing lower extremity function: association with self-reported disability and prediction of mortality and nursing home admission. J Gerontol. 1994 Mar;49(2):M85-94. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Mortality rate 36 months
Secondary Hospitalisation rate 36 months
Secondary Healthcare resource usage 36 months
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