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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Asthma

Intervention / Treatment
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* Behavioral: Pedometer-based physical activity prescription


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pedometer-based prescription<br>After baseline assessments, the control group will receive a educational session, regarding important aspects of asthma (symptoms, treatment, exacerbations, triggers, etc) plus a unsupervised exercise prescription (walking, 5 times per week, for at least 30 minutes) and a pedometer-based physical activity prescription, consisting of targets to be achieved (in terms of steps per day). | Behavioral: Pedometer-based physical activity prescription<br>* After baseline assessments, both groups will receive a educational session, regarding important aspects of asthma plus a unsupervised exercise prescription (walking, 5 times per week, for at least 30 minutes). Only the experimental group will receive a pedometer-based physical activity prescription, consisting of targets (steps per day) to be achieved. The initial target will be determined based on the average of steps per day assessed during the baseline assessments plus 1000 steps. The targets will be biweekly. Both groups will be contact once a week (by phone) and will be asked to return for asthma control assessments once a month.<br>|
| No Intervention: Control<br>After baseline assessments, the control group will receive a educational session, regarding important aspects of asthma (symptoms, treatment, exacerbations, triggers, etc) plus a unsupervised exercise prescription (walking, 5 times per week, for at least 30 minutes). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lifestyle physical activity | The lifestyle physical activity will be estimated as the mean number of steps taken in six days using a pedometer (SW200, YAMAX,Tokyo, Japan) | 12 weeks | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Physical Activity, Pedometers, Quality of Life