A Randomized Trial of Changing Exercise and Physical Activity Behavior in Asthma Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 258
- Locations
- 1
- Primary Endpoint
- The primary outcome will be change in Paffenbarger Physical Activity and Exercise Index scores from enrollment to 12 months.
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Control Group
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.
Intervention Group
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.
Intervention: Intervention Group (Behavioral)
Outcomes
Primary Outcomes
The primary outcome will be change in Paffenbarger Physical Activity and Exercise Index scores from enrollment to 12 months.
Time Frame: every 2 months for 1 year
Secondary Outcomes
- 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)
Investigators
Mary E. Charlson, MD
Principal Investigator
Weill Medical College of Cornell University