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

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ClinicalTrials.gov Identifier: NCT00195117
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : February 23, 2017
Sponsor:
Information provided by (Responsible Party):
Mary E. Charlson, MD, Weill Medical College of Cornell University

Tracking Information
First Submitted Date  ICMJE September 14, 2005
First Posted Date  ICMJE September 19, 2005
Last Update Posted Date February 23, 2017
Actual Study Start Date  ICMJE October 2004
Actual Primary Completion Date July 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 9, 2008)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 14, 2005)
The primary outcome will be change in Paffenbarger Physical Activity and Exercise Index scores from enrollment to 12 months.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 9, 2008)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 14, 2005)
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Randomized Trial of Changing Exercise and Physical Activity Behavior in Asthma Patients
Official Title  ICMJE A Randomized Trial of Changing Exercise and Physical Activity Behavior in Asthma Patients
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Condition  ICMJE Asthma
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 9, 2008)
258
Original Enrollment  ICMJE
 (submitted: September 14, 2005)
246
Actual Study Completion Date  ICMJE July 2007
Actual Primary Completion Date July 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00195117
Other Study ID Numbers  ICMJE N01-HC-25196 (030200599)
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: No Plan to Share IPD
Responsible Party Mary E. Charlson, MD, Weill Medical College of Cornell University
Study Sponsor  ICMJE Weill Medical College of Cornell University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Carol A Mancuso, MD Weill Medical College of Cornell University
Principal Investigator: Mary E Charlson, MD Weill Medical College of Cornell University
PRS Account Weill Medical College of Cornell University
Verification Date February 2017

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