NCT01739751

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

November 29, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 3, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

December 4, 2012

Status Verified

November 1, 2012

Enrollment Period

2.2 years

First QC Date

November 29, 2012

Last Update Submit

December 3, 2012

Conditions

COPD

Keywords

COPDPhysical activityPedometersstepsnon pharmacological treatmentrehabilitationexercise

Outcome Measures

Primary Outcomes (1)

  • effect in average steps walked daily

    Comparison between both groups in the difference of the average of steps walked daily at final evaluation with the basal evaluation

    3 months

Secondary Outcomes (3)

  • six minute walking distance

    3 months

  • score in the Saint George Respiratory Questionnaire

    3 months

  • Score of the COPD Assessment Test (CAT)

    3 months

Study Arms (2)

Control Group

NO INTERVENTION

Patients without feedback of a pedometers, followed for 3 months

Pedometers

EXPERIMENTAL

With a program of physical activity enhancement using pedometers as a feedback

Device: pedometers

Interventions

pedometersDEVICE

portable device that estimate the number of steps walked daily

Also known as: PD 724
Pedometers

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clínico Universidad de Chile

Santiago, Santiago Metropolitan, 8380456, Chile

Location

Related Publications (1)

  • Bravata DM, Smith-Spangler C, Sundaram V, Gienger AL, Lin N, Lewis R, Stave CD, Olkin I, Sirard JR. Using pedometers to increase physical activity and improve health: a systematic review. JAMA. 2007 Nov 21;298(19):2296-304. doi: 10.1001/jama.298.19.2296.

    PMID: 18029834BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveMotor Activity

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Laura Mendoza, MD

    Hospital Clínico University of Chile

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

November 29, 2012

First Posted

December 3, 2012

Study Start

January 1, 2011

Primary Completion

March 1, 2013

Study Completion

April 1, 2013

Last Updated

December 4, 2012

Record last verified: 2012-11

Locations

CL(1)