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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00195117
• Other study ID #: N01-HC-25196 (030200599)
• Status: Completed
• Phase: N/A
• First received: September 14, 2005
• Last updated: February 17, 2017
• Start date: October 2004
• Est. completion date: July 2007

Study information

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

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 258
• Est. completion date: July 2007
• Est. primary completion date: July 2006
• 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

• 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.

Related Conditions & MeSH terms

• Asthma

Intervention

Behavioral:
• 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.

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 (6)

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. — View 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. — 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, 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

Mancuso CA, Rincon M, Robbins L, Charlson ME. Patients' expectations of asthma treatment. J Asthma. 2003 Dec;40(8):873-81. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome will be change in Paffenbarger Physical Activity and Exercise Index scores from enrollment to 12 months.		every 2 months for 1 year
Secondary	Pedometer readings from enrollment to 12 months.		every 2 months for 1 year
Secondary	Change in asthma status measured by the Asthma Control Questionnaire from enrollment to 12 months.		baseline and one year after enrollment at closeout
Secondary	Change in quality of life measured by the Asthma Quality of Life Questionnaire enrollment to 12 months.		at baseline, 4-,8-month follow-ups and one year after enrollment at closeout
Secondary	Changes in the SF-12 from enrollment to 12 months.		baseline and one year after enrollment at closeout