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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mary E. Charlson, MD, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00195117
First received: September 14, 2005
Last updated: February 17, 2017
Last verified: February 2017

September 14, 2005
February 17, 2017
October 2004
July 2006   (Final data collection date for primary outcome measure)
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 ]
The primary outcome will be change in Paffenbarger Physical Activity and Exercise Index scores from enrollment to 12 months.
Complete list of historical versions of study NCT00195117 on ClinicalTrials.gov Archive Site
  • Pedometer readings from enrollment to 12 months. [ Time Frame: every 2 months for 1 year ]
  • 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 ]
  • 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 ]
  • Changes in the SF-12 from enrollment to 12 months. [ Time Frame: baseline and one year after enrollment at closeout ]
  • 1. Pedometer readings from enrollment to 12 months.
  • 2. Change in asthma status measured by the Asthma Control Questionnaire from enrollment to 12 months.
  • 3. Change in quality of life measured by the Asthma Quality of Life Questionnaire and the SF-12 from enrollment to 12 months.
Not Provided
Not Provided
 
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
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.
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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant
Primary Purpose: Other
Asthma
Behavioral: Intervention 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.
Other Name: Positive affect and self-affirmation induction
  • No Intervention: 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.
  • Experimental: 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: Behavioral: Intervention Group

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
258
July 2007
July 2006   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00195117
N01-HC-25196 (030200599)
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
No
No Plan to Share IPD
Mary E. Charlson, MD, Weill Medical College of Cornell University
Weill Medical College of Cornell University
Not Provided
Principal Investigator: Carol A Mancuso, MD Weill Medical College of Cornell University
Principal Investigator: Mary E Charlson, MD Weill Medical College of Cornell University
Weill Medical College of Cornell University
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP