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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Royal Brompton & Harefield NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01719822
First received: July 20, 2012
Last updated: November 4, 2014
Last verified: November 2014
  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:


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 ]

Enrollment: 155
Study Start Date: July 2012
Estimated Study Completion Date: March 2015
Primary Completion Date: May 2014 (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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: July 20, 2012
Last Updated: November 4, 2014
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
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Bronchial Diseases
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on November 19, 2014