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

History of Changes

Tracking Information

First Received Date ^ICMJE

September 23, 2005

Last Updated Date

April 9, 2008

Start Date ^ICMJE

February 2004

Primary Completion Date

May 2004 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Change in Paffenbarger Physical Activity and Exercise Index scores from enrollment to 4 weeks.

Change History

Complete list of historical versions of study NCT00227162 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

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 ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)

Condition ^ICMJE

Asthma

Intervention ^ICMJE

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

Study Arm (s)

Active Comparator: 1
Positive affect

Intervention: Behavioral: Self-affirmation and positive affect induction
Active Comparator: 2
Self-Affirmation

Intervention: Behavioral: Self-affirmation and positive affect induction
Active Comparator: 3
Positive Affect and self-affirmation

Intervention: Behavioral: Self-affirmation and positive affect induction
No Intervention: 4
Control group

Intervention: Behavioral: Self-affirmation and positive affect induction

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

May 2004

Primary Completion Date

May 2004 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00227162

Other Study ID Numbers ^ICMJE

N01-HC-25196 (0103-661)

Has Data Monitoring Committee

Yes

Responsible Party

Mary E. Charlson, MD, Weill Cornell Medical College

Study Sponsor ^ICMJE

Weill Medical College of Cornell University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:	Carol A Mancuso, MD	Weill Medical College of Cornell University
Study Director:	Mary E Charlson, MD	Weill Medical College of Cornell University

Information Provided By

Weill Medical College of Cornell University

Verification Date

April 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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