A Randomized Trial of Changing Exercise and Physical Activity Behavior in Asthma Patients

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00195117
First received: September 14, 2005
Last updated: March 7, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention
Asthma
Behavioral: Positive affect and self-affirmation induction

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Official Title: A Randomized Trial of Changing Exercise and Physical Activity Behavior in Asthma Patients

Resource links provided by NLM:


Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • The primary outcome will be change in Paffenbarger Physical Activity and Exercise Index scores from enrollment to 12 months. [ Time Frame: every 2 months for 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pedometer readings from enrollment to 12 months. [ Time Frame: every 2 months for 1 year ] [ Designated as safety issue: No ]
  • Change in asthma status measured by the Asthma Control Questionnaire from enrollment to 12 months. [ Time Frame: baseline and one year after enrollment at closeout ] [ Designated as safety issue: No ]
  • Change in quality of life measured by the Asthma Quality of Life Questionnaire enrollment to 12 months. [ Time Frame: at baseline, 4-,8-month follow-ups and one year after enrollment at closeout ] [ Designated as safety issue: No ]
  • Changes in the SF-12 from enrollment to 12 months. [ Time Frame: baseline and one year after enrollment at closeout ] [ Designated as safety issue: No ]

Enrollment: 258
Study Start Date: October 2004
Study Completion Date: July 2007
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1
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.
Behavioral: Positive affect and self-affirmation induction
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.
Other Name: Postivie affect and self-affirmation induction vs. control
Experimental: 2
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: Positive affect and self-affirmation induction
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.
Other Name: Postivie affect and self-affirmation induction vs. control

Detailed Description:

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. At the start of the trial 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. All patients will record perceived exertion and pedometer measurements in a log diary. All patients will be contacted by telephone at set time intervals to encourage them to continue their selected physical activity or exercise. Patients randomized to the intervention arm will also receive induced positive affect and self-affirmation throughout the study period. Patients in the control arm will not receive the positive affect and self-affirmation components.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00195117

Locations
United States, New York
New York Presbyterian Hospital-Weill Medical College of Cornell University
New York, New York, United States, 10021
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Principal Investigator: Carol A Mancuso, MD Weill Medical College of Cornell University
Principal Investigator: Mary E Charlson, MD Weill Medical College of Cornell University
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Carol A. Mancuso, Weill Cornell Medical College
ClinicalTrials.gov Identifier: NCT00195117     History of Changes
Other Study ID Numbers: N01-HC-25196 (030200599)
Study First Received: September 14, 2005
Last Updated: March 7, 2012
Health Authority: United States: Federal Government

Keywords provided by Weill Medical College of Cornell University:
Asthma
Behavior change
Physical activity
Risk reduction

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 20, 2014