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

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Yamax Digi-Walker CW-700
Sponsored by
Royal Brompton & Harefield NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Lung Diseases, Obstructive focused on measuring 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]

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Harefield Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual Care

Intervention

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change from baseline of Incremental Shuttle Walk
Change from baseline of Chronic Respiratory Disease Questionaire (CRDQ)
Change from baseline of Medical Outcomes Survey Short Form 36 item questionaire SF-36

Full Information

First Posted
July 20, 2012
Last Updated
May 12, 2015
Sponsor
Royal Brompton & Harefield NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT01719822
Brief Title
Physical Activity Augmentation Using Pedometers During Pulmonary Rehabilitation in Chronic Obstructive Pulmonary Disease
Official Title
Physical Activity Augmentation Using Pedometers During Pulmonary Rehabilitation in Chronic Obstructive Pulmonary Disease
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Royal Brompton & Harefield NHS Foundation Trust

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Diseases, Obstructive, Pulmonary Disease, Chronic Obstructive, Bronchitis, 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]

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
155 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Standard 8-week pulmonary rehabilitation programme with 2 supervised sessions per week and a written home exercise plan/diary.
Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Yamax Digi-Walker CW-700
Intervention Description
A pedometer with a daily step count target set by a physiotherapist.
Primary Outcome Measure Information:
Title
Change from baseline of time spent in at least moderate physical activity (3>METS equivalent)
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Change from baseline of Incremental Shuttle Walk
Time Frame
8 weeks
Title
Change from baseline of Chronic Respiratory Disease Questionaire (CRDQ)
Time Frame
8 weeks
Title
Change from baseline of Medical Outcomes Survey Short Form 36 item questionaire SF-36
Time Frame
8 weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William DC Man, MRCP, PhD
Organizational Affiliation
Respiratory Biomedical Research Unit, Royal Brompton & Harefield NHS Foundation Trust and Imperial College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
Harefield Hospital
City
Middlesex
ZIP/Postal Code
UB9 6JH
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
19305235
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.
Results Reference
background
PubMed Identifier
18029834
Citation
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.
Results Reference
background
PubMed Identifier
17158282
Citation
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.
Results Reference
background
PubMed Identifier
27911566
Citation
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.
Results Reference
derived

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

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