Physical Activity Enhancement Using Pedometers in COPD

COPD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01739751
• Other study ID #: SA10i20022
• Status: Active, not recruiting
• Phase: N/A
• First received: November 29, 2012
• Last updated: December 3, 2012
• Start date: January 2011
• Est. completion date: April 2013

Study information

• Verified date: November 2012
• Source: University of Chile
• Contact: n/a
• Is FDA regulated: No
• Health authority: Chile: Comisión Nacional de Investigación Científica y Tecnológica
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 90
• Est. completion date: April 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• COPD

Intervention

Device:
• pedometers
portable device that estimate the number of steps walked daily

Locations

Country	Name	City	State
Chile	Hospital Clínico Universidad de Chile	Santiago	Región Metropolitana

Sponsors (2)

Lead Sponsor	Collaborator
University of Chile	Comisión Nacional de Investigación Científica y Tecnológica

Country where clinical trial is conducted

Chile, 

References & 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	six minute walking distance	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	No
Secondary	score in the Saint George Respiratory Questionnaire	Comparison between groups in the difference of the score of the SGRQ at the final evaluation in comparison with the basal evaluation	3 months	No
Secondary	Score of the COPD Assessment Test (CAT)	Comparison between groups in the difference of the CAT score at the final evaluation with the basal evaluation	3 months	No