Pilot Study of Changing Exercise and Physical Activity Behavior in Asthma Patients - Full Text View

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:

MedlinePlus related topics: Asthma Exercise and Physical Fitness

U.S. FDA Resources

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

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:

Mancuso CA, Rincon M, McCulloch CE, Charlson ME. Self-efficacy, depressive symptoms, and patients' expectations predict outcomes in asthma. Med Care. 2001 Dec;39(12):1326-38.

Mancuso CA, Peterson MG. Different methods to assess quality of life from multiple follow-ups in a longitudinal asthma study. J Clin Epidemiol. 2004 Jan;57(1):45-54.

Mancuso CA, Peterson MG, Charlson ME. Comparing discriminative validity between a disease-specific and a general health scale in patients with moderate asthma. J Clin Epidemiol. 2001 Mar;54(3):263-74.

Mancuso CA, Rincon M, Charlson ME. Adverse work outcomes and events attributed to asthma. Am J Ind Med. 2003 Sep;44(3):236-45.

Mancuso CA, Peterson MG, Charlson ME. Effects of depressive symptoms on health-related quality of life in asthma patients. J Gen Intern Med. 2000 May;15(5):301-10.

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 May 19, 2013