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

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ClinicalTrials.gov Identifier: NCT00227162
Recruitment Status : Completed
First Posted : September 27, 2005
Last Update Posted : February 23, 2017
Sponsor:
Information provided by (Responsible Party):
Mary E. Charlson, MD, Weill Medical College of Cornell University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Asthma Behavioral: Group 1 Behavioral: Group 2 Behavioral: Group 3 Not Applicable

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: Pilot Study of Changing Exercise and Physical Activity Behavior in Asthma Patients
Study Start Date : February 2004
Actual Primary Completion Date : May 2004
Actual Study Completion Date : May 2004

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Group 1
Positive affect
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
Active Comparator: Group 2
Self-Affirmation
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
Active Comparator: Group 3
Positive Affect and 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
No Intervention: Group 4
Control group



Primary Outcome Measures :
  1. Change in Paffenbarger Physical Activity and Exercise Index scores from enrollment to 4 weeks. [ Time Frame: 1-2 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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, 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00227162


Locations
United States, New York
New York Presbyterian Hospital-Weill Medical College of Cornell University
New York, New York, United States, 10021
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Principal Investigator: Carol A Mancuso, MD Weill Medical College of Cornell University
Study Director: Mary E Charlson, MD Weill Medical College of Cornell University

Publications:
Responsible Party: Mary E. Charlson, MD, Principal Investigator, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT00227162     History of Changes
Other Study ID Numbers: N01-HC-25196 (0103-661)
First Posted: September 27, 2005    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No Plan to Share IPD

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mary E. Charlson, MD, Weill Medical College of Cornell University:
Asthma
Behavior change
Physical activity
Risk reduction

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases