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Clinical Trials/NCT00195117
NCT00195117
Completed
N/A

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

Weill Medical College of Cornell University1 site in 1 country258 target enrollmentOctober 2004
ConditionsAsthma

Overview

Phase
N/A
Intervention
Not specified
Conditions
Asthma
Sponsor
Weill Medical College of Cornell University
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.
Status
Completed
Last Updated
9 years ago

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.

Registry
clinicaltrials.gov
Start Date
October 2004
End Date
July 2007
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mary E. Charlson, MD

Principal Investigator

Weill Medical College of Cornell University

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
  • 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.

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)

Study Sites (1)

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