Clinical trial NCT00195117: A Randomized Trial of Changing Exercise and Physical Activity Behavior in Asthma Patients
Official title: A Randomized Trial of Changing Exercise and Physical Activity Behavior in Asthma Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: Asthma
Behavior change
Physical activity
Risk reduction
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2005-09-19
Enrollment: 258
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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 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.

Primary outcomes:
measure: The primary outcome will be change in Paffenbarger Physical Activity and Exercise Index scores from enrollment to 12 months.
timeFrame: every 2 months for 1 year
Secondary outcomes:
measure: Pedometer readings from enrollment to 12 months.
timeFrame: every 2 months for 1 year
measure: Change in asthma status measured by the Asthma Control Questionnaire from enrollment to 12 months.
timeFrame: baseline and one year after enrollment at closeout
measure: Change in quality of life measured by the Asthma Quality of Life Questionnaire enrollment to 12 months.
timeFrame: at baseline, 4-,8-month follow-ups and one year after enrollment at closeout
measure: Changes in the SF-12 from enrollment to 12 months.
timeFrame: baseline and one year after enrollment at closeout
Other outcomes:
Locations:
city: New York
country: United States
facility: New York Presbyterian Hospital-Weill Medical College of Cornell University
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Carol A Mancuso, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Weill Medical College of Cornell University
name: Mary E Charlson, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.
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.
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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.