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

This study is currently recruiting participants.

Verified October 2012 by Royal Brompton & Harefield NHS Foundation Trust

Sponsor:

Information provided by (Responsible Party):

Royal Brompton & Harefield NHS Foundation Trust

ClinicalTrials.gov Identifier:

NCT01719822

First received: July 20, 2012

Last updated: October 30, 2012

Last verified: October 2012

History of Changes

Purpose

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.

Condition	Intervention
Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Bronchitis, Chronic	Device: Yamax Digi-Walker CW-700

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Supportive Care
Official Title:	Physical Activity Augmentation Using Pedometers During Pulmonary Rehabilitation in Chronic Obstructive Pulmonary Disease

Resource links provided by NLM:

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease) Chronic Bronchitis Exercise and Physical Fitness Rehabilitation

U.S. FDA Resources

Further study details as provided by Royal Brompton & Harefield NHS Foundation Trust:

Primary Outcome Measures:

Change from baseline of time spent in at least moderate physical activity (3>METS equivalent) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline of Incremental Shuttle Walk [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Change from baseline of Chronic Respiratory Disease Questionaire (CRDQ) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Change from baseline of Medical Outcomes Survey Short Form 36 item questionaire SF-36 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	130
Study Start Date:	July 2012
Estimated Study Completion Date:	April 2014
Estimated Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
No Intervention: Usual Care Standard 8-week pulmonary rehabilitation programme with 2 supervised sessions per week and a written home exercise plan/diary.
Experimental: Intervention Standard 8-week pulmonary rehabilitation programme with 2 supervised sessions per week. In addition they will receive a pedometer with a daily step count target set by a physiotherapist and a written home exercise plan/diary.	Device: Yamax Digi-Walker CW-700 A pedometer with a daily step count target set by a physiotherapist.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01719822

Contacts

Contact: William DC Man, MRCP. PhD

01895 823 737 ext 5851

w.man@rbht.nhs.uk

Locations

United Kingdom
Harefield Hospital	Recruiting
Middlesex, United Kingdom, UB9 6JH
Contact: William DC Man, M 01895 823 737 ext 5851 w.man@rbht.nhs.uk
Principal Investigator: William DC Man, MRCP, PhD

Sponsors and Collaborators

Royal Brompton & Harefield NHS Foundation Trust

Investigators

Principal Investigator:

William DC Man, MRCP, PhD

Respiratory Biomedical Research Unit, Royal Brompton & Harefield NHS Foundation Trust and Imperial College London

More Information

Publications:

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.

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.

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.

Responsible Party:	Royal Brompton & Harefield NHS Foundation Trust
ClinicalTrials.gov Identifier:	NCT01719822 History of Changes
Other Study ID Numbers:	2012LF002H
Study First Received:	July 20, 2012
Last Updated:	October 30, 2012
Health Authority:	United Kingdom: National Health Service United Kingdom: National Institute for Health Research United Kingdom: Research Ethics Committee

Keywords provided by Royal Brompton & Harefield NHS Foundation Trust:

Treatment Outcome [E01.789.800]
Rehabilitation [N02.421.784]
Physical Fitness [I03.621]

Lung Diseases, Obstructive [C08.381.495]
Pulmonary Disease, Chronic Obstructive [C08.381.495.389]
Bronchitis, Chronic [C08.381.495.389.500]

Additional relevant MeSH terms:

Bronchitis
Bronchitis, Chronic
Chronic Disease
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive

Lung Diseases, Obstructive
Bronchial Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013

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