Back to resultsA Randomized Trial of Changing Exercise and Physical Activity Behavior in Asthma Patients
Primary Purpose
Asthma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intervention Group
Sponsored by
About this trial
This is an interventional other trial for Asthma focused on measuring Asthma, Behavior change, Physical activity, Risk reduction
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.
Sites / Locations
- New York Presbyterian Hospital-Weill Medical College of Cornell University
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control Group
Intervention Group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
The primary outcome will be change in Paffenbarger Physical Activity and Exercise Index scores from enrollment to 12 months.
Secondary Outcome Measures
Pedometer readings from enrollment to 12 months.
Change in asthma status measured by the Asthma Control Questionnaire from enrollment to 12 months.
Change in quality of life measured by the Asthma Quality of Life Questionnaire enrollment to 12 months.
Changes in the SF-12 from enrollment to 12 months.
Full Information
NCT ID
NCT00195117
First Posted
September 14, 2005
Last Updated
February 17, 2017
Sponsor
Weill Medical College of Cornell University
1. Study Identification
Unique Protocol Identification Number
NCT00195117
Brief Title
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
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
October 2004 (Actual)
Primary Completion Date
July 2006 (Actual)
Study Completion Date
July 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Weill Medical College of Cornell University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma, Behavior change, Physical activity, Risk reduction
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
258 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Intervention Group
Other Intervention Name(s)
Positive affect and self-affirmation induction
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Pedometer readings from enrollment to 12 months.
Time Frame
every 2 months for 1 year
Title
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
Title
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
Title
Changes in the SF-12 from enrollment to 12 months.
Time Frame
baseline and one year after enrollment at closeout
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carol A Mancuso, MD
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mary E Charlson, MD
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York Presbyterian Hospital-Weill Medical College of Cornell University
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No Plan to Share IPD
Citations:
PubMed Identifier
15019010
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.
Results Reference
background
PubMed Identifier
14736086
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.
Results Reference
background
PubMed Identifier
11717574
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.
Results Reference
background
PubMed Identifier
11223324
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.
Results Reference
background
PubMed Identifier
10840265
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.
Results Reference
background
PubMed Identifier
22269593
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.
Results Reference
result
PubMed Identifier
23173979
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.
Results Reference
derived
PubMed Identifier
19441600
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.
Results Reference
derived
PubMed Identifier
19055202
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.
Results Reference
derived
PubMed Identifier
18569235
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.
Results Reference
derived
PubMed Identifier
18415830
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.
Results Reference
derived
PubMed Identifier
18263683
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.
Results Reference
derived
PubMed Identifier
17530534
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.
Results Reference
derived
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A Randomized Trial of Changing Exercise and Physical Activity Behavior in Asthma Patients
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