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Clinical Trials/NCT00227162
NCT00227162CompletedNot Applicable

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

Weill Medical College of Cornell University1 site in 1 country40 target enrollmentStarted: February 1, 2004Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
40
Locations
1
Primary Endpoint
Change in Paffenbarger Physical Activity and Exercise Index scores from enrollment to 4 weeks.

Study Overview

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 Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Group 1

Active Comparator

Positive affect

Intervention: Group 1 (Behavioral)

Group 2

Active Comparator

Self-Affirmation

Intervention: Group 2 (Behavioral)

Group 3

Active Comparator

Positive Affect and self-affirmation

Intervention: Group 3 (Behavioral)

Group 4

No Intervention

Control group

Outcomes

Primary Outcomes

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

Time Frame: 1-2 weeks

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mary E. Charlson, MD

Principal Investigator

Weill Medical College of Cornell University

Study Sites (1)

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