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CompletedNCT00227162Updated Feb 23, 2017

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

An interventional study of Group 1 and Group 2 in Asthma, sponsored by Weill Medical College of Cornell University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-02-23.

Sponsored by Weill Medical College of Cornell University · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

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Conditions studied

  • Asthma

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Keywords

  • Asthma
  • Behavior change
  • Physical activity
  • Risk reduction
03

In context

Asthma

3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.

This study's enrollment of 40 is below the median of 83 across 2,752 interventional studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

Weill Medical College of Cornell University is the lead sponsor of 867 studies on the registry; 160 are open to participants now.

Of its 119 completed or terminated interventional studies of FDA-regulated products, 91 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
40 participants (actual)

Study arms

  • Active comparator
    Group 1

    Positive affect

    Behavioral: Group 1

  • Active comparator
    Group 2

    Self-Affirmation

    Behavioral: Group 2

  • Active comparator
    Group 3

    Positive Affect and self-affirmation

    Behavioral: Group 3

  • No intervention
    Group 4

    Control group

Interventions

  • BehavioralGroup 1

    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

  • BehavioralGroup 2

    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

  • BehavioralGroup 3

    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

06

What researchers measure

Primary outcomes

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

    Time frame: 1-2 weeks

07

Study locations

1 site
  • New York Presbyterian Hospital-Weill Medical College of Cornell University
    New York, New York 10021, United States
08

References and documents

Publications

  • 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. PubMed 11717574 ↗
  • 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. PubMed 15019010 ↗
  • 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. PubMed 11223324 ↗
  • 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. PubMed 12929143 ↗
  • 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. PubMed 10840265 ↗

Individual participant data

Plan to share: No — No Plan to Share IPD

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 23, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00227162
Lead sponsor
Weill Medical College of Cornell University
Responsible party
Mary E. Charlson, MD (Principal Investigator, Weill Medical College of Cornell University) — Principal investigator
First posted
Sep 27, 2005
Start date
Feb 2004
Primary completion
May 2004
Completion
May 2004
Last update
Feb 23, 2017

Study contacts

Carol A Mancuso, MD
principal investigator · Weill Medical College of Cornell University
Mary E Charlson, MD
study director · Weill Medical College of Cornell University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.

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