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Completed

NCT Number: NCT00195117

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York Presbyterian Hospital-Weill Medical College of Cornell University

New York, 10021, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intervention Group

Behavioral

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.

Other names: Positive affect and self-affirmation induction

Primary outcomes

  1. 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

  1. Pedometer readings from enrollment to 12 months.

    Time frame: every 2 months for 1 year

  2. Change in asthma status measured by the Asthma Control Questionnaire from enrollment to 12 months.

    Time frame: baseline and one year after enrollment at closeout

  3. Change in quality of life measured by the Asthma Quality of Life Questionnaire enrollment to 12 months.

    Time frame: at baseline, 4-,8-month follow-ups and one year after enrollment at closeout

  4. Changes in the SF-12 from enrollment to 12 months.

    Time frame: baseline and one year after enrollment at closeout

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Registry information

Important dates

Study start
2004
Primary completion
2006
Study completion
2007
First posted
Sep 19, 2005
Registry last updated
Feb 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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