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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01509443 |
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Date of registration:
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02/01/2012 |
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Primary sponsor: |
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Public title:
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Breathing & Mild Physical Exercise Therapy for Asthma
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Scientific title:
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Application of Breathing Exercise Program to Improve Asthma in Obese Patients: Effects on Clinico-immunological Parameters |
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Date of first enrolment:
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April 2012 |
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Target sample size:
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200 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01509443 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Kuwait
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Contacts
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Name:
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Fahad Al-Ghimlas, MD |
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Address:
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Telephone:
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965 2224 2999 |
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Email:
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fahad.alghimlas@dasmaninstitute.org |
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Affiliation:
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Name:
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Fahad Al-Ghimlas, MD |
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Address:
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Telephone:
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965 2224 2999 |
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Email:
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fahad.alghimlas@dasmaninstitute.org |
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Affiliation:
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Name:
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Fahad Al-Ghimlas, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Co-Principal Investigator, Dasman Diabetes Institute |
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Name:
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Said Dermime, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Co-Principal Investigator, Dasman Diabetes Institute |
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Name:
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Rasheed Ahmad, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Principal Investigator, Dasman Diabetes Institute |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Individuals who report a physician-made diagnosis of asthma
- Non-smokers and ex-smokers (should have stopped smoking at least 1 year ago)
Exclusion Criteria:
- Contraindications to exercise
- Inability to exercise
- Current smokers or those who stopped smoking within the last week
- Presence of other lung diseases besides asthma
- Patients on systemic steroids
- Major co-morbidities inhibiting participants from being involved in an exercise
program
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Asthma
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Intervention(s)
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Other: Exercise
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Primary Outcome(s)
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Change in Post-bronchodilator Forced Expired Volume in one second (FEV1)
[Time Frame: At baseline (pre-exercise) and two different time points (3 and 6 months of post-exercise)]
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Secondary Outcome(s)
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Change in Fraction of exhaled nitric oxide (FeNO)
[Time Frame: At baseline (pre-exercise) and two diiferent time points (3 and 6 months of post-exercise)]
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Change in Immunological Markers
[Time Frame: At baseline (pre-exercise) and two different time points (3 and 6 months of post-exercise)]
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Improvement in other pulmonary functions as well as quality of life assessment
[Time Frame: At baseline (pre-exercise) and two different time points (3 and 6 months of post-exercise)]
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Secondary ID(s)
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RA-2011-015
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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