Effects of a Pedometer-based Unsupervised Exercise Program Upon Lifestyle Physical Activity of Asthmatic Adults

Not Applicable

Completed

• Conditions: Asthma

• Registration Number: NCT01984281
• Lead Sponsor: Federal University of Juiz de Fora

Brief Summary

The purpose of this study is to determine whether a pedometer-based unsupervised exercise program is more effective than a general exercise recommendation to increase lifestyle physical activity in adult patients with asthma.

Detailed Description

The patients will be randomized in two groups: the intervention group will receive a standardized advice to physical activity practice plus pedometers and step goals to achieve over the next twelve weeks and the control group will receive the same standardized advice to physical activity practice and usual care.

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2013-11-08
• Study First Submitted QC: 2013-11-08
• Study First Posted: 2013-11-14
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-13
• Last Update Posted: 2017-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

Inclusion Criteria

• Asthma diagnosis for at least 6 months (according to Global Initiative for Asthma criteria)
• Regular drug therapy (inhaled corticosteroids or inhaled corticosteroids plus long-acting beta-agonists)
• Clinical stability during the run-in period (3 weeks)

Exclusion Criteria

• Physical activity practice over once a week
• Disabling musculoskeletal disease
• Cardiopathy
• Other lung disease
• More than 10 pack-years of smoking
• Pregnancy
• Refusal to participate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Lifestyle physical activity	12 weeks	The lifestyle physical activity will be estimated as the mean number of steps taken in six days using a pedometer (SW200, YAMAX,Tokyo, Japan)

Secondary Outcome Measures

Name	Time	Method
Asthma Control	12 weeks	Asthma Control will be assessed through the Asthma Control Questionnaire
Depression and anxiety	12 weeks	Depression and anxiety will be assessed through the Hospital Anxiety and Depression Scale
Exercise capacity	12 weeks	Exercise capacity will be assessed through the six-minute walking teste.
Asthma Health related quality of life	12 weeks	Asthma Health related quality of life will be assessed through the Asthma Quality of Life Questionnaire.
Asthma exacerbations	12 weeks	Asthma exacerbations will be assessed through exacerbation diaries.

Trial Locations

Locations (1)

University Hospital of the Federal University of Juiz de Fora; 🇧🇷 Juiz de Fora, Minas Gerais, Brazil