NCT00195117

Brief Summary

The primary objective of this randomized trial is to evaluate a novel intervention of induced positive affect and induced self-affirmation to increase physical activity in patients with asthma.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
258

participants targeted

Target at P75+ for not_applicable asthma

Timeline
Completed

Started Oct 2004

Typical duration for not_applicable asthma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

September 14, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2006

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

February 23, 2017

Status Verified

February 1, 2017

Enrollment Period

1.7 years

First QC Date

September 14, 2005

Last Update Submit

February 17, 2017

Conditions

Asthma

Keywords

AsthmaBehavior changePhysical activityRisk reduction

Outcome Measures

Primary Outcomes (1)

  • The primary outcome will be change in Paffenbarger Physical Activity and Exercise Index scores from enrollment to 12 months.

    every 2 months for 1 year

Secondary Outcomes (4)

  • Pedometer readings from enrollment to 12 months.

    every 2 months for 1 year

  • Change in asthma status measured by the Asthma Control Questionnaire from enrollment to 12 months.

    baseline and one year after enrollment at closeout

  • Change in quality of life measured by the Asthma Quality of Life Questionnaire enrollment to 12 months.

    at baseline, 4-,8-month follow-ups and one year after enrollment at closeout

  • Changes in the SF-12 from enrollment to 12 months.

    baseline and one year after enrollment at closeout

Study Arms (2)

Control Group

NO INTERVENTION

This group received follow-up every 2-months for one year. Follow-up included questions about their asthma and how well they had been able to engage in their doctor approved physical activity goal.

Intervention Group

EXPERIMENTAL

This group received follow-up every 2-months for one year. Follow-up included questions about their asthma and how well they had been able to engage in their doctor approved physical activity goal, which was the same as the control arm. Additionally, subjects in this arm were encouraged to use positive affect and self-affirmation techniques to motivate an increased level of participation in their physical activity goal. These subjects also received small token gifts to remind them of their participation in this study.

Behavioral: Intervention Group

Interventions

Intervention GroupBEHAVIORAL

Subjects were randomly assigned to either the control or the intervention group. The intervention included receiving an additional educational workbook about using positive affect and self affirmation, as well as participating in using positive affect and self-affirmation to motivate behavior change, which in this case was to increase their physical activity level. Patient also received small token gifts to remind them of their participation in the study and to induce positive affect. The control group also set a physical activity goal and received the same follow-up, but did not participate in the positive affect and self-affirmation portion.

Also known as: Positive affect and self-affirmation induction
Intervention Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York Presbyterian Hospital-Weill Medical College of Cornell University

New York, New York, 10021, United States

Location

Related Publications (13)

  • 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.

    PMID: 15019010BACKGROUND

  • Mancuso CA, Rincon M, Robbins L, Charlson ME. Patients' expectations of asthma treatment. J Asthma. 2003 Dec;40(8):873-81. doi: 10.1081/jas-120023578.

    PMID: 14736086BACKGROUND

  • 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.

    PMID: 11717574BACKGROUND

  • 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.

    PMID: 11223324BACKGROUND

  • 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.

    PMID: 10840265BACKGROUND

  • Mancuso CA, Choi TN, Westermann H, Wenderoth S, Hollenberg JP, Wells MT, Isen AM, Jobe JB, Allegrante JP, Charlson ME. Increasing physical activity in patients with asthma through positive affect and self-affirmation: a randomized trial. Arch Intern Med. 2012 Feb 27;172(4):337-43. doi: 10.1001/archinternmed.2011.1316. Epub 2012 Jan 23.

    PMID: 22269593RESULT

  • Mancuso CA, Choi TN, Westermann H, Wenderoth S, Wells MT, Charlson ME. Improvement in asthma quality of life in patients enrolled in a prospective study to increase lifestyle physical activity. J Asthma. 2013 Feb;50(1):103-7. doi: 10.3109/02770903.2012.743150. Epub 2012 Nov 22.

    PMID: 23173979DERIVED

  • Mancuso CA, Sayles W, Allegrante JP. Development and testing of the Asthma Self-Management Questionnaire. Ann Allergy Asthma Immunol. 2009 Apr;102(4):294-302. doi: 10.1016/S1081-1206(10)60334-1.

    PMID: 19441600DERIVED

  • Westermann H, Choi TN, Briggs WM, Charlson ME, Mancuso CA. Obesity and exercise habits of asthmatic patients. Ann Allergy Asthma Immunol. 2008 Nov;101(5):488-94. doi: 10.1016/S1081-1206(10)60287-6.

    PMID: 19055202DERIVED

  • Choi TN, Westermann H, Sayles W, Mancuso CA, Charlson ME. Beliefs about asthma medications: patients perceive both benefits and drawbacks. J Asthma. 2008 Jun;45(5):409-14. doi: 10.1080/02770900801971834.

    PMID: 18569235DERIVED

  • Mancuso CA, Westermann H, Choi TN, Wenderoth S, Briggs WM, Charlson ME. Psychological and somatic symptoms in screening for depression in asthma patients. J Asthma. 2008 Apr;45(3):221-5. doi: 10.1080/02770900701883766.

    PMID: 18415830DERIVED

  • Mancuso CA, Wenderoth S, Westermann H, Choi TN, Briggs WM, Charlson ME. Patient-reported and physician-reported depressive conditions in relation to asthma severity and control. Chest. 2008 May;133(5):1142-8. doi: 10.1378/chest.07-2243. Epub 2008 Feb 8.

    PMID: 18263683DERIVED

  • Mancuso CA, Choi TN, Westermann H, Briggs WM, Wenderoth S, Charlson ME. Measuring physical activity in asthma patients: two-minute walk test, repeated chair rise test, and self-reported energy expenditure. J Asthma. 2007 May;44(4):333-40. doi: 10.1080/02770900701344413.

    PMID: 17530534DERIVED

MeSH Terms

Conditions

AsthmaMotor ActivityRisk Reduction Behavior

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesBehavior

Study Officials

  • Carol A Mancuso, MD

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR

  • Mary E Charlson, MD

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 14, 2005

First Posted

September 19, 2005

Study Start

October 1, 2004

Primary Completion

July 1, 2006

Study Completion

July 1, 2007

Last Updated

February 23, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

No Plan to Share IPD

Locations

US(1)