Physical Activity Enhancement Using Pedometers in COPD

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Comisión Nacional de Investigación Científica y Tecnológica
Information provided by (Responsible Party):
Dr. Laura Mendoza, University of Chile
ClinicalTrials.gov Identifier:
NCT01739751
First received: November 29, 2012
Last updated: December 3, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention
COPD
Device: pedometers

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of a Program of Physical Activity Enhancement Using Pedometers in Chronic Obstructive Pulmonary Disease

Further study details as provided by University of Chile:

Primary Outcome Measures:
  • effect in average steps walked daily [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Comparison between both groups in the difference of the average of steps walked daily at final evaluation with the basal evaluation


Secondary Outcome Measures:
  • six minute walking distance [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Comparison between groups in the difference of the distance( meters) in the six minute walking test in the final evaluation with the basal evaluation

  • score in the Saint George Respiratory Questionnaire [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Comparison between groups in the difference of the score of the SGRQ at the final evaluation in comparison with the basal evaluation

  • Score of the COPD Assessment Test (CAT) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Comparison between groups in the difference of the CAT score at the final evaluation with the basal evaluation


Enrollment: 90
Study Start Date: January 2011
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: PD 724

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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01739751

Locations
Chile
Hospital Clínico Universidad de Chile
Santiago, Región Metropolitana, Chile, 8380456
Sponsors and Collaborators
University of Chile
Comisión Nacional de Investigación Científica y Tecnológica
Investigators
Principal Investigator: Laura Mendoza, MD Hospital Clínico University of Chile
  More Information

Publications:
Responsible Party: Dr. Laura Mendoza, MD, University of Chile
ClinicalTrials.gov Identifier: NCT01739751     History of Changes
Other Study ID Numbers: SA10i20022
Study First Received: November 29, 2012
Last Updated: December 3, 2012
Health Authority: Chile: Comisión Nacional de Investigación Científica y Tecnológica

Keywords provided by University of Chile:
COPD
Physical activity
Pedometers
steps
non pharmacological treatment
rehabilitation
exercise

Additional relevant MeSH terms:
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 22, 2014