A Randomized Trial of Changing Exercise and Physical Activity Behavior in Asthma Patients

Study Overview
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Brief Summary
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The primary objective of this randomized trial is to evaluate a novel intervention of induced positive affect and induced self-affirmation to increase physical activity in patients with asthma.

Detailed Description
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The primary objective of this randomized trial is to evaluate a novel intervention of induced positive affect and induced self-affirmation to increase physical activity in patients with asthma. At the start of the trial all patients in conjunction with their physicians will select a program of mild to moderate physical activity or exercise to be adopted and maintained on a routine basis. All patients will record perceived exertion and pedometer measurements in a log diary. All patients will be contacted by telephone at set time intervals to encourage them to continue their selected physical activity or exercise. Patients randomized to the intervention arm will also receive induced positive affect and self-affirmation throughout the study period. Patients in the control arm will not receive the positive affect and self-affirmation components.

Official Title
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A Randomized Trial of Changing Exercise and Physical Activity Behavior in Asthma Patients

Conditions
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Asthma

Intervention / Treatment
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* Behavioral: Intervention Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients will be eligible for this study if their physicians consider them medically able to participate, if they are 18 years of age or older if they have a diagnosis of mild to moderate asthma based on the NHLBI Asthma Expert Panel's classification system which rates symptoms, frequency of exacerbations, nocturnal attacks, activity restriction, use of medications, and pulmonary function. Exclusion Criteria: Patients will be excluded from this study for the following reasons: If they are unable to walk several blocks for whatever reason; If they have musculoskeletal or neurological deficits that preclude increased physical activity; If they have other pulmonary diseases; If they have cardiac disease or other severe comorbidity; If they are unable to provide informed consent because of cognitive deficits; If they refuse to participate.

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| No Intervention: Control Group<br>This group received follow-up every 2-months for one year. Follow-up included questions about their asthma and how well they had been able to engage in their doctor approved physical activity goal. | |
| Experimental: Intervention Group<br>This group received follow-up every 2-months for one year. Follow-up included questions about their asthma and how well they had been able to engage in their doctor approved physical activity goal, which was the same as the control arm. Additionally, subjects in this arm were encouraged to use positive affect and self-affirmation techniques to motivate an increased level of participation in their physical activity goal. These subjects also received small token gifts to remind them of their participation in this study. | Behavioral: Intervention Group<br>* Subjects were randomly assigned to either the control or the intervention group. The intervention included receiving an additional educational workbook about using positive affect and self affirmation, as well as participating in using positive affect and self-affirmation to motivate behavior change, which in this case was to increase their physical activity level. Patient also received small token gifts to remind them of their participation in the study and to induce positive affect. The control group also set a physical activity goal and received the same follow-up, but did not participate in the positive affect and self-affirmation portion.<br>* Other names: Positive affect and self-affirmation induction;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome will be change in Paffenbarger Physical Activity and Exercise Index scores from enrollment to 12 months. |  | every 2 months for 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pedometer readings from enrollment to 12 months. |  | every 2 months for 1 year | 
| Change in asthma status measured by the Asthma Control Questionnaire from enrollment to 12 months. |  | baseline and one year after enrollment at closeout | 
| Change in quality of life measured by the Asthma Quality of Life Questionnaire enrollment to 12 months. |  | at baseline, 4-,8-month follow-ups and one year after enrollment at closeout | 
| Changes in the SF-12 from enrollment to 12 months. |  | baseline and one year after enrollment at closeout | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthma, Behavior change, Physical activity, Risk reduction