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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00227162
Other study ID # N01-HC-25196 (0103-661)
Secondary ID
Status Completed
Phase N/A
First received September 23, 2005
Last updated February 17, 2017
Start date February 2004
Est. completion date May 2004

Study information

Verified date February 2017
Source Weill Medical College of Cornell University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

The goals of this pilot study are to empirically test different interventional approaches to induce positive affect and self-affirmation. At the start of the study 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. Patients also will complete the Paffenbarger Physical Activity and Exercise Index. Patients then will be divided into four groups according to the intervention they receive: 1) positive affect; 2) self-affirmation; 3) positive affect and self-affirmation; 4) control. The main outcome is the change in the Paffenbarger Physical Activity and Exercise Index scores from enrollment to 4 weeks.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date May 2004
Est. primary completion date May 2004
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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, 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.

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.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Group 1
Patients set a physical activity goal and were assigned to one of four groups. Patients were assigned to receive positive affect intervention.
Group 2
Patients set a physical activity goal and were assigned to one of four groups. Patients were assigned to receive the self-affirmation intervention.
Group 3
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.

Locations

Country Name City State
United States New York Presbyterian Hospital-Weill Medical College of Cornell University New York New York

Sponsors (1)

Lead Sponsor Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View 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. — View 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. — View Citation

Mancuso CA, Rincon M, Charlson ME. Adverse work outcomes and events attributed to asthma. Am J Ind Med. 2003 Sep;44(3):236-45. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Paffenbarger Physical Activity and Exercise Index scores from enrollment to 4 weeks. 1-2 weeks
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