A Randomized Trial of Changing Exercise and Physical Activity Behavior in Asthma Patients
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| First Received Date ICMJE | September 14, 2005 | ||||||||
| Last Updated Date | March 7, 2012 | ||||||||
| Start Date ICMJE | October 2004 | ||||||||
| Primary Completion Date | July 2006 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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 ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE |
The primary outcome will be change in Paffenbarger Physical Activity and Exercise Index scores from enrollment to 12 months. | ||||||||
| Change History | Complete list of historical versions of study NCT00195117 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) |
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| Condition ICMJE | Asthma | ||||||||
| Intervention ICMJE | Behavioral: Positive affect and self-affirmation induction
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: Postivie affect and self-affirmation induction vs. control |
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| Study Arm (s) |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 258 | ||||||||
| Completion Date | July 2007 | ||||||||
| 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
Exclusion Criteria: Patients will be excluded from this study for the following reasons:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00195117 | ||||||||
| Other Study ID Numbers ICMJE | N01-HC-25196 (030200599) | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Carol A. Mancuso, Weill Cornell Medical College | ||||||||
| Study Sponsor ICMJE | Weill Medical College of Cornell University | ||||||||
| Collaborators ICMJE | National Heart, Lung, and Blood Institute (NHLBI) | ||||||||
| Investigators ICMJE |
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| Information Provided By | Weill Medical College of Cornell University | ||||||||
| Verification Date | March 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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