We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01719822
Recruitment Status : Completed
First Posted : November 1, 2012
Last Update Posted : May 13, 2015
Sponsor:
Information provided by (Responsible Party):

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.

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 155 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Physical Activity Augmentation Using Pedometers During Pulmonary Rehabilitation in Chronic Obstructive Pulmonary Disease
Study Start Date : July 2012
Primary Completion Date : February 2015
Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. Change from baseline of time spent in at least moderate physical activity (3>METS equivalent) [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Change from baseline of Incremental Shuttle Walk [ Time Frame: 8 weeks ]
  2. Change from baseline of Chronic Respiratory Disease Questionaire (CRDQ) [ Time Frame: 8 weeks ]
  3. Change from baseline of Medical Outcomes Survey Short Form 36 item questionaire SF-36 [ Time Frame: 8 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01719822


Locations
United Kingdom
Harefield Hospital
Middlesex, United Kingdom, UB9 6JH
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:
Responsible Party: Royal Brompton & Harefield NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01719822     History of Changes
Other Study ID Numbers: 2012LF002H
First Posted: November 1, 2012    Key Record Dates
Last Update Posted: May 13, 2015
Last Verified: May 2015

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:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Chronic Disease
Respiratory Tract Diseases
Disease Attributes
Bronchial Diseases
Bronchitis
Bronchitis, Chronic
Pathologic Processes
Respiratory Tract Infections