Physical Activity Augmentation Using Pedometers During Pulmonary Rehabilitation in Chronic Obstructive Pulmonary Disease

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

Physical Activity Augmentation Using Pedometers During Pulmonary Rehabilitation in Chronic Obstructive Pulmonary Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01719822
• Other study ID #: 2012LF002H
• 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

• Bronchitis
• Bronchitis, Chronic
• Chronic Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

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