Integrative Medicine Approach to the Management of Asthma in Adults - Full Text View

Sponsor:	Beth Israel Medical Center
Information provided by:	Beth Israel Medical Center
ClinicalTrials.gov Identifier:	NCT00843544

Purpose

The overall aim of this research project is to test the effectiveness of an integrative program, using journaling, yoga breathing instruction, and nutritional manipulation and supplementation, on quality of life and clinical outcomes in adults with asthma. An additional aim is to determine whether an integrative approach to asthma management leads to cost savings when compared to standard clinical care.Patients will be randomly assigned to either the intervention condition or a waitlist control condition. For the intervention group, all measures will be obtained at baseline, immediately after the treatment protocol is completed, and then at three month and six month intervals after the completion of the intervention. For the control group, data will be collected at the same times as the intervention group, with one exception: data collected at the completion of the treatment protocol will be replaced with data collection at six weeks post-baseline for the control group. Data will be collected using measures of quality of life (Asthma Quality of Life Questionnaire and SF-12), pulmonary function and health care utilization and expenditures.

Participants assigned to the treatment group will begin in groups of ten. The treatment protocol will consist of six 1-2 hour sessions over a six-week period as follows:

Subjects will attend a two-session class on healthy eating focused on reducing inflammation-promoting foods in the diet. All subjects will also be started on fish oil and vitamin C supplements, as well as on a supplement called Kaprex, which is an extract from hops and rosemary with anti-inflammatory action. Supplements willl be provided free of charge. Subjects will be provided with a take home supply to begin using.
Subjects will attend two classes at CCHH in yoga breathing techniques and will then be provided with a CD for home study and practice
Subjects will attend two guided journaling sessions at CCHH in which subjects will be asked to write for a 30-minute period about the most traumatic or stressful life experience to date.

Condition	Intervention	Phase
Asthma	Behavioral: Integrative Medicine	Phase II Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Effect of an Integrative Medicine Approach to the Management of Asthma in Adults on Quality of Life and Clinical Outcomes

Resource links provided by NLM:

MedlinePlus related topics: Asthma Dietary Supplements

U.S. FDA Resources

Further study details as provided by Beth Israel Medical Center:

Primary Outcome Measures:

Asthma Quality of Life Questionnaire [ Time Frame: Baseline, 6 weeks, 3 months, 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Medical Outcomes Study Short Form-12 (SF-12) [ Time Frame: Baseline, 6 weeks, 3 months, 6 months ] [ Designated as safety issue: Yes ]

Enrollment:	156
Study Start Date:	March 2006
Study Completion Date:	July 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Integrative Medicine	Behavioral: Integrative Medicine Participants assigned to the treatment group will begin in groups of ten. The treatment protocol will consist of six 1-2 hour sessions over a six-week period as follows: Subjects will attend a two-session class on healthy eating focused on reducing inflammation-promoting foods in the diet. All subjects will also be started on fish oil and vitamin C supplements, as well as on a supplement called Kaprex, which is an extract from hops and rosemary with anti-inflammatory action. Supplements willl be provided free of charge. Subjects will be provided with a take home supply to begin using. Subjects will attend two classes at CCHH in yoga breathing techniques and will then be provided with a CD for home study and practice Subjects will attend two guided journaling sessions at CCHH in which subjects will be asked to write for a 30-minute period about the most traumatic or stressful life experience to date.
No Intervention: Control

Arms

Assigned Interventions

Experimental: Integrative Medicine

Behavioral: Integrative Medicine

Participants assigned to the treatment group will begin in groups of ten. The treatment protocol will consist of six 1-2 hour sessions over a six-week period as follows:

Subjects will attend a two-session class on healthy eating focused on reducing inflammation-promoting foods in the diet. All subjects will also be started on fish oil and vitamin C supplements, as well as on a supplement called Kaprex, which is an extract from hops and rosemary with anti-inflammatory action. Supplements willl be provided free of charge. Subjects will be provided with a take home supply to begin using.
Subjects will attend two classes at CCHH in yoga breathing techniques and will then be provided with a CD for home study and practice
Subjects will attend two guided journaling sessions at CCHH in which subjects will be asked to write for a 30-minute period about the most traumatic or stressful life experience to date.

No Intervention: Control

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age 18-80
Class II through IV asthma sufferers will be included (mild persistent; moderate persistent; severe persistent).
Ability to read and write at minimum fifth grade level
Willing to comply with study instructions and sign an informed consent
English-speaking

Exclusion Criteria:

Pregnancy or lactation
Concurrent serious or life-threatening illness as determined by clinical judgment
Psychiatric disorder as determined by clinical judgment.
Inability to understand or follow the instructions associated with the clinical study as determined by clinical judgment.
Fish allergy or history of adverse reaction to vitamin C or fish oil as determined by clinical history.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00843544

Locations

United States, New York
Beth Israel Medical Center/Center for Health and Healing
NY, New York, United States, 10016

Sponsors and Collaborators

Beth Israel Medical Center

More Information

No publications provided by Beth Israel Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Kligler B, Homel P, Blank AE, Kenney J, Levenson H, Merrell W. Randomized trial of the effect of an integrative medicine approach to the management of asthma in adults on disease-related quality of life and pulmonary function. Altern Ther Health Med. 2011 Jan-Feb;17(1):10-5.

Responsible Party:	Benjamin Kligler, Beth Israel Medical Center
ClinicalTrials.gov Identifier:	NCT00843544 History of Changes
Other Study ID Numbers:	170-05
Study First Received:	February 12, 2009
Last Updated:	February 12, 2009
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases

Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on February 09, 2012