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

This study has been completed.
Sponsor:
Information provided by:
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00227162
First received: September 23, 2005
Last updated: April 9, 2008
Last verified: April 2008
  Purpose

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 Intervention
Asthma
Behavioral: Self-affirmation and positive affect induction

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Official Title: Pilot Study of Changing Exercise and Physical Activity Behavior in Asthma Patients

Resource links provided by NLM:


Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • Change in Paffenbarger Physical Activity and Exercise Index scores from enrollment to 4 weeks. [ Time Frame: 1-2 weeks ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: February 2004
Study Completion Date: May 2004
Primary Completion Date: May 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Positive affect
Behavioral: Self-affirmation and positive affect induction
Patients set a physical activity goal and were assigned to one of four groups. Patients were assigned to receive the self-affirmation intervention, positive affect intervention, both positive affect and self-affirmation intervention or no intervention.
Other Names:
  • Positive Affect
  • Self-affirmation
  • Positive Affect and Self-Affirmation
  • Control
Active Comparator: 2
Self-Affirmation
Behavioral: Self-affirmation and positive affect induction
Patients set a physical activity goal and were assigned to one of four groups. Patients were assigned to receive the self-affirmation intervention, positive affect intervention, both positive affect and self-affirmation intervention or no intervention.
Other Names:
  • Positive Affect
  • Self-affirmation
  • Positive Affect and Self-Affirmation
  • Control
Active Comparator: 3
Positive Affect and self-affirmation
Behavioral: Self-affirmation and positive affect induction
Patients set a physical activity goal and were assigned to one of four groups. Patients were assigned to receive the self-affirmation intervention, positive affect intervention, both positive affect and self-affirmation intervention or no intervention.
Other Names:
  • Positive Affect
  • Self-affirmation
  • Positive Affect and Self-Affirmation
  • Control
No Intervention: 4
Control group
Behavioral: Self-affirmation and positive affect induction
Patients set a physical activity goal and were assigned to one of four groups. Patients were assigned to receive the self-affirmation intervention, positive affect intervention, both positive affect and self-affirmation intervention or no intervention.
Other Names:
  • Positive Affect
  • Self-affirmation
  • Positive Affect and Self-Affirmation
  • Control

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:
Responsible Party: Mary E. Charlson, MD, Weill Cornell Medical College
ClinicalTrials.gov Identifier: NCT00227162     History of Changes
Other Study ID Numbers: N01-HC-25196 (0103-661)
Study First Received: September 23, 2005
Last Updated: April 9, 2008
Health Authority: United States: Federal Government

Keywords provided by 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

ClinicalTrials.gov processed this record on July 23, 2014