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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01719822
Other study ID # 2012LF002H
Secondary ID
Status Completed
Phase N/A
First received July 20, 2012
Last updated May 12, 2015
Start date July 2012
Est. completion date February 2015

Study information

Verified date May 2015
Source Royal Brompton & Harefield NHS Foundation Trust
Contact n/a
Is FDA regulated No
Health authority United Kingdom: National Health ServiceUnited Kingdom: National Institute for Health ResearchUnited Kingdom: Research Ethics Committee
Study type Interventional

Clinical Trial Summary

Patients with chronic lung diseases such as Chronic Obstructive Pulmonary Disease (COPD), who perform regular physical activity, have improved health and wellbeing compared with those who do little exercise. The purpose of the study is to evaluate whether the use of a simple pedometer (step counter) to set targets for daily physical activity can encourage COPD patients referred for an 8-week pulmonary exercise based programme (PR) to be more active. The investigators also want to know whether the use of pedometers during PR can improve adherence, self-management and outcome in COPD.


Recruitment information / eligibility

Status Completed
Enrollment 155
Est. completion date February 2015
Est. primary completion date February 2015
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- All patients with COPD

Exclusion Criteria:

- Any patient in whom mobility and lower limb function have been significantly affected by a neuromuscular disease, severe peripheral vascular disease or amputation

- Any patient whom the chief investigator feels it is unsafe to exercise (eg. unstable cardiac disease)

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

Device:
Yamax Digi-Walker CW-700
A pedometer with a daily step count target set by a physiotherapist.

Locations

Country Name City State
United Kingdom Harefield Hospital Middlesex

Sponsors (1)

Lead Sponsor Collaborator
Royal Brompton & Harefield NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (3)

Bravata DM, Smith-Spangler C, Sundaram V, Gienger AL, Lin N, Lewis R, Stave CD, Olkin I, Sirard JR. Using pedometers to increase physical activity and improve health: a systematic review. JAMA. 2007 Nov 21;298(19):2296-304. Review. — View Citation

Butler L, Furber S, Phongsavan P, Mark A, Bauman A. Effects of a pedometer-based intervention on physical activity levels after cardiac rehabilitation: a randomized controlled trial. J Cardiopulm Rehabil Prev. 2009 Mar-Apr;29(2):105-14. doi: 10.1097/HCR.0b013e31819a01ff. — View Citation

Garcia-Aymerich J, Lange P, Benet M, Schnohr P, Antó JM. Regular physical activity modifies smoking-related lung function decline and reduces risk of chronic obstructive pulmonary disease: a population-based cohort study. Am J Respir Crit Care Med. 2007 Mar 1;175(5):458-63. Epub 2006 Dec 7. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline of time spent in at least moderate physical activity (3>METS equivalent) 8 weeks No
Secondary Change from baseline of Incremental Shuttle Walk 8 weeks No
Secondary Change from baseline of Chronic Respiratory Disease Questionaire (CRDQ) 8 weeks No
Secondary Change from baseline of Medical Outcomes Survey Short Form 36 item questionaire SF-36 8 weeks No
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