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

NCT ID: NCT00195117

Last Updated: 2017-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

258 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Study Completion Date

2007-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Asthma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control Group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention Group

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.

Group Type EXPERIMENTAL

Intervention Group

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Intervention Group

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.

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Positive affect and self-affirmation induction

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Weill Medical College of Cornell University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mary E. Charlson, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Carol A Mancuso, MD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Mary E Charlson, MD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

New York Presbyterian Hospital-Weill Medical College of Cornell University

New York, New York, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 15019010 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14736086 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11717574 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11223324 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10840265 (View on PubMed)

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.

Reference Type RESULT
PMID: 22269593 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23173979 (View on PubMed)

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.

Reference Type DERIVED
PMID: 19441600 (View on PubMed)

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.

Reference Type DERIVED
PMID: 19055202 (View on PubMed)

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.

Reference Type DERIVED
PMID: 18569235 (View on PubMed)

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.

Reference Type DERIVED
PMID: 18415830 (View on PubMed)

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.

Reference Type DERIVED
PMID: 18263683 (View on PubMed)

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.

Reference Type DERIVED
PMID: 17530534 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

N01HC25196

Identifier Type: NIH

Identifier Source: secondary_id

View Link

N01-HC-25196 (030200599)

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.