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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00195117
Enrollment
258
Registered
2005-09-19
Start date
2004-10-31
Completion date
2007-07-31
Last updated
2017-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

Asthma, Behavior change, Physical activity, Risk reduction

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.

Interventions

BEHAVIORALIntervention Group

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.

Sponsors

Weill Medical College of Cornell University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime 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

MeasureTime 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 5, 2026