NCT01719822

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
155

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2012

Typical duration for not_applicable

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

July 1, 2012

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

July 20, 2012

Completed
3 months until next milestone

First Posted

Study publicly available on registry

November 1, 2012

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

May 13, 2015

Status Verified

May 1, 2015

Enrollment Period

2.6 years

First QC Date

July 20, 2012

Last Update Submit

May 12, 2015

Conditions

Lung Diseases, ObstructivePulmonary Disease, Chronic ObstructiveBronchitis, Chronic

Keywords

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]

Outcome Measures

Primary Outcomes (1)

  • Change from baseline of time spent in at least moderate physical activity (3>METS equivalent)

    8 weeks

Secondary Outcomes (3)

  • Change from baseline of Incremental Shuttle Walk

    8 weeks

  • Change from baseline of Chronic Respiratory Disease Questionaire (CRDQ)

    8 weeks

  • Change from baseline of Medical Outcomes Survey Short Form 36 item questionaire SF-36

    8 weeks

Study Arms (2)

Usual Care

NO INTERVENTION

Standard 8-week pulmonary rehabilitation programme with 2 supervised sessions per week and a written home exercise plan/diary.

Intervention

EXPERIMENTAL

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

Interventions

Yamax Digi-Walker CW-700DEVICE

A pedometer with a daily step count target set by a physiotherapist.

Intervention

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All patients with COPD

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Harefield Hospital

Middlesex, UB9 6JH, United Kingdom

Location

Related Publications (4)

  • 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.

    PMID: 19305235BACKGROUND

  • 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. doi: 10.1001/jama.298.19.2296.

    PMID: 18029834BACKGROUND

  • Garcia-Aymerich J, Lange P, Benet M, Schnohr P, Anto 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. doi: 10.1164/rccm.200607-896OC. Epub 2006 Dec 7.

    PMID: 17158282BACKGROUND

  • Nolan CM, Maddocks M, Canavan JL, Jones SE, Delogu V, Kaliaraju D, Banya W, Kon SSC, Polkey MI, Man WD. Pedometer Step Count Targets during Pulmonary Rehabilitation in Chronic Obstructive Pulmonary Disease. A Randomized Controlled Trial. Am J Respir Crit Care Med. 2017 May 15;195(10):1344-1352. doi: 10.1164/rccm.201607-1372OC.

    PMID: 27911566DERIVED

MeSH Terms

Conditions

Lung Diseases, ObstructivePulmonary Disease, Chronic ObstructiveBronchitis, ChronicLung DiseasesBronchitis

Condition Hierarchy (Ancestors)

Respiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsRespiratory Tract InfectionsInfectionsBronchial Diseases

Study Officials

  • William DC Man, MRCP, PhD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2012

First Posted

November 1, 2012

Study Start

July 1, 2012

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

May 13, 2015

Record last verified: 2015-05

Locations

GB(1)