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

Sponsor

Royal Brompton & Harefield NHS Foundation Trust (Other)

Overall Status

Completed

CT.gov ID

NCT01719822

Collaborator

(none)

155

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

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	Phase
Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Bronchitis, Chronic	Device: Yamax Digi-Walker CW-700	N/A

Study Design

Study Type:

Interventional

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 :

Jul 1, 2012

Actual Primary Completion Date :

Feb 1, 2015

Actual Study Completion Date :

Feb 1, 2015

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.

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

Change from baseline of time spent in at least moderate physical activity (3>METS equivalent) [8 weeks]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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