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Pilot Study of Changing Exercise and Physical Activity Behavior in Asthma Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00227162
First Posted: September 27, 2005
Last Update Posted: February 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Mary E. Charlson, MD, Weill Medical College of Cornell University
September 23, 2005
September 27, 2005
February 23, 2017
February 2004
May 2004   (Final data collection date for primary outcome measure)
Change in Paffenbarger Physical Activity and Exercise Index scores from enrollment to 4 weeks. [ Time Frame: 1-2 weeks ]
Change in Paffenbarger Physical Activity and Exercise Index scores from enrollment to 4 weeks.
Complete list of historical versions of study NCT00227162 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Pilot Study of Changing Exercise and Physical Activity Behavior in Asthma Patients
Pilot Study of Changing Exercise and Physical Activity Behavior in Asthma Patients
The objective of this pilot study is to assess the feasibility and the potential differential impact of a novel intervention of induced positive affect and self-affirmation to increase physical activity in asthma patients.
The goals of this pilot study are to empirically test different interventional approaches to induce positive affect and self-affirmation. At the start of the study 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. Patients also will complete the Paffenbarger Physical Activity and Exercise Index. Patients then will be divided into four groups according to the intervention they receive: 1) positive affect; 2) self-affirmation; 3) positive affect and self-affirmation; 4) control. The main outcome is the change in the Paffenbarger Physical Activity and Exercise Index scores from enrollment to 4 weeks.
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Asthma
  • Behavioral: Group 1
    Patients set a physical activity goal and were assigned to one of four groups. Patients were assigned to receive positive affect intervention.
    Other Names:
    • Positive Affect
    • Control
  • Behavioral: Group 2
    Patients set a physical activity goal and were assigned to one of four groups. Patients were assigned to receive the self-affirmation intervention.
    Other Name: Self-affirmation
  • Behavioral: Group 3
    Patients set a physical activity goal and were assigned to one of four groups. Patients were assigned to receive both positive affect and self-affirmation intervention.
    Other Name: Positive Affect and Self-Affirmation
  • Active Comparator: Group 1
    Positive affect
    Intervention: Behavioral: Group 1
  • Active Comparator: Group 2
    Self-Affirmation
    Intervention: Behavioral: Group 2
  • Active Comparator: Group 3
    Positive Affect and self-affirmation
    Intervention: Behavioral: Group 3
  • No Intervention: Group 4
    Control group

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
May 2004
May 2004   (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, and 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
 
 
NCT00227162
N01-HC-25196 (0103-661)
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Plan Description: 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
Study Director: 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