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

Primary Purpose

Asthma

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Group 1

Group 2

Group 3

About this trial

This is an interventional other trial for Asthma focused on measuring Asthma, Behavior change, Physical activity, Risk reduction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

New York Presbyterian Hospital-Weill Medical College of Cornell University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

No Intervention

Arm Label

Group 1

Group 2

Group 3

Group 4

Arm Description

Positive affect

Self-Affirmation

Positive Affect and self-affirmation

Control group

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT00227162

First Posted

September 23, 2005

Last Updated

February 17, 2017

Sponsor

Weill Medical College of Cornell University

1. Study Identification

Unique Protocol Identification Number

NCT00227162

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Completed

Study Start Date

February 2004 (undefined)

Primary Completion Date

May 2004 (Actual)

Study Completion Date

May 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Weill Medical College of Cornell University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma

Keywords

Asthma, Behavior change, Physical activity, Risk reduction

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Non-Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group 1

Arm Type

Active Comparator

Arm Description

Positive affect

Arm Title

Group 2

Arm Type

Active Comparator

Arm Description

Self-Affirmation

Arm Title

Group 3

Arm Type

Active Comparator

Arm Description

Positive Affect and self-affirmation

Arm Title

Group 4

Arm Type

No Intervention

Arm Description

Control group

Intervention Type

Behavioral

Intervention Name(s)

Group 1

Other Intervention Name(s)

Positive Affect, Control

Intervention Description

Patients set a physical activity goal and were assigned to one of four groups. Patients were assigned to receive positive affect intervention.

Intervention Type

Behavioral

Intervention Name(s)

Group 2

Other Intervention Name(s)

Self-affirmation

Intervention Description

Patients set a physical activity goal and were assigned to one of four groups. Patients were assigned to receive the self-affirmation intervention.

Intervention Type

Behavioral

Intervention Name(s)

Group 3

Other Intervention Name(s)

Positive Affect and Self-Affirmation

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Time Frame

1-2 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Carol A Mancuso, MD

Organizational Affiliation

Weill Medical College of Cornell University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Mary E Charlson, MD

Organizational Affiliation

Weill Medical College of Cornell University

Official's Role

Study Director

Facility Information:

Facility Name

New York Presbyterian Hospital-Weill Medical College of Cornell University

City

New York

State/Province

New York

ZIP/Postal Code

10021

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

No Plan to Share IPD

Citations:

PubMed Identifier

11717574

Citation

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. doi: 10.1097/00005650-200112000-00008.

Results Reference

background

PubMed Identifier

15019010

Citation

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. doi: 10.1016/S0895-4356(03)00248-8.

Results Reference

background

PubMed Identifier

11223324

Citation

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. doi: 10.1016/s0895-4356(00)00307-3.

Results Reference

background

PubMed Identifier

12929143

Citation

Mancuso CA, Rincon M, Charlson ME. Adverse work outcomes and events attributed to asthma. Am J Ind Med. 2003 Sep;44(3):236-45. doi: 10.1002/ajim.10257.

Results Reference

background

PubMed Identifier

10840265

Citation

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. doi: 10.1046/j.1525-1497.2000.07006.x.

Results Reference

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

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