Pilot Study of Changing Exercise and Physical Activity Behavior in Asthma Patients

Study Overview
=================
Brief Summary
-----------------
The objective of this pilot study is to assess the feasibility and the potential differential impact of a novel intervention of induced positive affect and self-affirmation to increase physical activity in asthma patients.

Detailed Description
-----------------
The goals of this pilot study are to empirically test different interventional approaches to induce positive affect and self-affirmation. At the start of the study 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. Patients also will complete the Paffenbarger Physical Activity and Exercise Index. Patients then will be divided into four groups according to the intervention they receive: 1) positive affect; 2) self-affirmation; 3) positive affect and self-affirmation; 4) control. The main outcome is the change in the Paffenbarger Physical Activity and Exercise Index scores from enrollment to 4 weeks.

Official Title
-----------------
Pilot Study of Changing Exercise and Physical Activity Behavior in Asthma Patients

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Behavioral: Group 1
* Behavioral: Group 2
* Behavioral: Group 3


Participation Criteria
=================
Eligibility Criteria
-----------------
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, and 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
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1<br>Positive affect | Behavioral: Group 1<br>* Patients set a physical activity goal and were assigned to one of four groups. Patients were assigned to receive positive affect intervention.<br>* Other names: Control;|
| Active Comparator: Group 2<br>Self-Affirmation | Behavioral: Group 2<br>* Patients set a physical activity goal and were assigned to one of four groups. Patients were assigned to receive the self-affirmation intervention.<br>* Other names: Self-affirmation;|
| Active Comparator: Group 3<br>Positive Affect and self-affirmation | Behavioral: Group 3<br>* Patients set a physical activity goal and were assigned to one of four groups. Patients were assigned to receive both positive affect and self-affirmation intervention.<br>* Other names: Positive Affect and Self-Affirmation;|
| No Intervention: Group 4<br>Control group | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Paffenbarger Physical Activity and Exercise Index scores from enrollment to 4 weeks. |  | 1-2 weeks | 

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