NCT00227162

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable asthma

Timeline
Completed

Started Feb 2004

Shorter than P25 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

February 1, 2004

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2004

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

September 23, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 27, 2005

Completed
Last Updated

February 23, 2017

Status Verified

February 1, 2017

Enrollment Period

3 months

First QC Date

September 23, 2005

Last Update Submit

February 17, 2017

Conditions

Keywords

AsthmaBehavior changePhysical activityRisk reduction

Outcome Measures

Primary Outcomes (1)

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

    1-2 weeks

Study Arms (4)

Group 1

ACTIVE COMPARATOR

Positive affect

Behavioral: Group 1

Group 2

ACTIVE COMPARATOR

Self-Affirmation

Behavioral: Group 2

Group 3

ACTIVE COMPARATOR

Positive Affect and self-affirmation

Behavioral: Group 3

Group 4

NO INTERVENTION

Control group

Interventions

Group 1BEHAVIORAL

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

Also known as: Positive Affect, Control
Group 1
Group 2BEHAVIORAL

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

Also known as: Self-affirmation
Group 2
Group 3BEHAVIORAL

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.

Also known as: Positive Affect and Self-Affirmation
Group 3

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, 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.

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 (5)

  • 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. 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, 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, 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.

    PMID: 12929143BACKGROUND
  • 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

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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON 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 23, 2005

First Posted

September 27, 2005

Study Start

February 1, 2004

Primary Completion

May 1, 2004

Study Completion

May 1, 2004

Last Updated

February 23, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

No Plan to Share IPD

Locations