Pilot Study of Changing Exercise and Physical Activity Behavior in Asthma Patients
2 other identifiers
interventional
40
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable asthma
Started Feb 2004
Shorter than P25 for not_applicable asthma
1 active site
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
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 23, 2005
CompletedFirst Posted
Study publicly available on registry
September 27, 2005
CompletedFebruary 23, 2017
February 1, 2017
3 months
September 23, 2005
February 17, 2017
Conditions
Keywords
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 COMPARATORPositive affect
Group 2
ACTIVE COMPARATORSelf-Affirmation
Group 3
ACTIVE COMPARATORPositive Affect and self-affirmation
Group 4
NO INTERVENTIONControl group
Interventions
Patients set a physical activity goal and were assigned to one of four groups. Patients were assigned to receive positive affect intervention.
Patients set a physical activity goal and were assigned to one of four groups. Patients were assigned to receive the self-affirmation intervention.
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.
Eligibility Criteria
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
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: 11717574BACKGROUNDMancuso 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: 15019010BACKGROUNDMancuso 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: 11223324BACKGROUNDMancuso 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: 12929143BACKGROUNDMancuso 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
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carol A Mancuso, MD
Weill Medical College of Cornell University
- STUDY DIRECTOR
Mary E Charlson, MD
Weill Medical College of Cornell University
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