Physical Activity Enhancement Using Pedometers in COPD

December 3, 2012 updated by: Dr. Laura Mendoza, University of Chile

Effect of a Program of Physical Activity Enhancement Using Pedometers in Chronic Obstructive Pulmonary Disease

Physical activity is reduced in COPD affecting morbidity and mortality and the usual advice is not good enough to increase the physical activity level. The aim of the study is to determine the effects of pedometers in the physical level in COPD patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Physical activity is reduced in COPD patients and has a negative effect in the morbidity and mortality of this condition. Unfortunately, usual advice is not good enough to reverse the sedentary condition in COPD patients. Pedometers are broadly used to measure and to enhance physical activity in COPD but their effects in COPD are not well known. The aim of the study is to determine the effects of a program using pedometers as a feedback in stable ex smokers COPD patients. Patients are recruited for a 3 months individual program promoting daily physical activity enhancement and are randomly assigned either to a pedometer-based program (experimental group) or to usual care (control group, the measurements at the beginning and at the end of the study are: anthropometrics, Spirometry, dyspnea, quality of life, exercise capacity and the average one week daily steps. Also the number of acute exacerbations during the follow up are recorded.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Chile
    • Región Metropolitana
      • Santiago, Región Metropolitana, Chile, 8380456
        • Hospital Clínico Universidad de Chile

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • COPD diagnosis according to GOLD guidelines
  • Pack year Index equal or more than 10
  • smoking suspended > 2 months
  • older than 40 years old,

Exclusion Criteria:

  • any chronic condition that does not allow walking
  • participation in a rehabilitation program
  • Acute exacerbation in the last two months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group
Patients without feedback of a pedometers, followed for 3 months
Experimental: Pedometers
With a program of physical activity enhancement using pedometers as a feedback
Device: pedometers
portable device that estimate the number of steps walked daily
Other Names:
  • PD 724

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
effect in average steps walked daily
Time Frame: 3 months
Comparison between both groups in the difference of the average of steps walked daily at final evaluation with the basal evaluation
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
six minute walking distance
Time Frame: 3 months
Comparison between groups in the difference of the distance( meters) in the six minute walking test in the final evaluation with the basal evaluation
3 months
score in the Saint George Respiratory Questionnaire
Time Frame: 3 months
Comparison between groups in the difference of the score of the SGRQ at the final evaluation in comparison with the basal evaluation
3 months
Score of the COPD Assessment Test (CAT)
Time Frame: 3 months
Comparison between groups in the difference of the CAT score at the final evaluation with the basal evaluation
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chile

Collaborators

Comisión Nacional de Investigación Científica y Tecnológica

Investigators

  • Principal Investigator: Laura Mendoza, MD, Hospital Clínico University of Chile

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Anticipated)

March 1, 2013

Study Completion (Anticipated)

April 1, 2013

Study Registration Dates

First Submitted

November 29, 2012

First Submitted That Met QC Criteria

November 29, 2012

First Posted (Estimate)

December 3, 2012

Study Record Updates

Last Update Posted (Estimate)

December 4, 2012

Last Update Submitted That Met QC Criteria

December 3, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SA10i20022

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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