Breathing & Mild Physical Exercise Therapy for Asthma
Primary Purpose
Asthma
Status
Completed
Phase
Not Applicable
Locations
Kuwait
Study Type
Interventional
Intervention
Exercise
Sponsored by

About this trial
This is an interventional supportive care trial for Asthma focused on measuring Asthma, Obesity, Breathing exercise
Eligibility Criteria
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
Sites / Locations
- Dasman Diabetes Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Interventional
Control Arm
Arm Description
Participants will receive standard asthmatic treatment and breathing/mild physical exercise
The control arm will receive standard medical care for asthma
Outcomes
Primary Outcome Measures
Change in Post-bronchodilator Forced Expired Volume in one second (FEV1)
Investigators are expecting positive changes (improvement) in Forced Expired Volume in one second (FEV1) over the course of time. FEV1 is an indicator of improvement in the lung functions and, therefore, asthma control.
Secondary Outcome Measures
Improvement in other pulmonary functions as well as quality of life assessment
Other pulmonary function tests will be measured for the assessment of pulmonary function. A standard Asthma Control Questionnaire will be used to measure improvement in the quality of life
Change in Fraction of exhaled nitric oxide (FeNO)
Change in Immunological Markers
To determine how the protocol specific intervention affects Immunological Markers.
Full Information
NCT ID
NCT01509443
First Posted
January 2, 2012
Last Updated
August 16, 2021
Sponsor
Dasman Diabetes Institute
1. Study Identification
Unique Protocol Identification Number
NCT01509443
Brief Title
Breathing & Mild Physical Exercise Therapy for Asthma
Official Title
Application of Breathing Exercise Program to Improve Asthma in Obese Patients: Effects on Clinico-immunological Parameters
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dasman Diabetes Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Overall goal: To apply the investigators' well defined simple, few-minute breathing/ mild physical exercise program and evaluate its efficacy/benefits for the improvement of clinico-immunological outcome in obese patients with asthma.
Rationale & Hypothesis: Different breathing exercise regimens currently recommended are not well defined and in certain cases may worsen dyspnea or even trigger an asthma attack. Therefore, it is important to evaluate the overall usefulness of a breathing exercise as a therapeutic intervention of asthma. In this regard, the investigators have designed an easy, few-minute breathing exercise program as a treatment modality for asthma and to evaluate its efficacy in improving associated clinico-immunological symptoms. The investigators hypothesize that the investigators' well-designed breathing/mild physical exercise intervention for obese patients will help alleviate the stress and symptoms of asthma by reducing the chronic low-grade systemic inflammation and thus potentiate the beneficial outcome of medication to render a better control over the disease and to improve the quality of life in obese patients.
Clinical relevance/Significance:
The investigators expect that their exercise module will help reduce inflammation caused by asthma, and thereby relieving symptoms of asthma. If successful, this would allow regular individualized exercise module to be recommended as a part of therapy for people with asthma, which could possibly reduce the dosage as well as frequency of taking medicine that they need.
Detailed Description
Asthmatics particularly obese have major constraints impeding regular physical activity and exercise. Indeed, the few studies that have resorted to the option of exercise in asthmatic patients also recognized the exacerbation of associated symptoms as a major limitation of this approach. Considering the other obstacles that are often involved, such as lack of time and motivation, inadequate social support and lack of access to facilities etc, it is therefore all the more necessary to design a simple, feasible and carefully tailored breathing exercise modality in obese patients with asthma, and to study its impact on the improvement of clinico-immunological parameters, lung function and overall quality of life. To this end, investigators have developed a safe and feasible light breathing exercise program for individuals with asthma based on our previous observations.
Study Aims & Objectives:
The investigators' main goal is to apply a well defined simple exercise program that includes physical and breathing exercise lessons and evaluate its effects on the improvement of clinico-immunological outcome in obese patients with asthma. There are three main objectives based on clinic-immunological outcome.
To assess the improvement of asthma control, lung function and airways hyper-reactivity after the intervention.
To test if the proposed intervention will result in the improvement of pro-inflammatory profiles.
To determine if physical and psychological performances as well as health related quality of life are positively impacted by the proposed exercise modality.
About 200 individuals with asthma will be enrolled in this study and divided into two groups: The intervention group and controls. The intervention group will receive standard asthma care along with breathing/mild physical exercise. The control group will be the asthmatic patients who are not willing to receive the exercise intervention. At study entry, participants will undergo a clinical assessment which includes physical exam, asthma control/ quality of life questionnaires, pulmonary function tests, and lung inflammation test (Exhaled Nitric Oxide). To monitor participants throughout the study, follow up visits will be done at 6, 12, 18 and 24 weeks after starting the exercise. About 40 ml blood will be collected at baseline (pre-exercise) and two different time points (3 and 6 months of post-exercise). The blood samples will be used for pro-inflammatory profiles. Duration of the study will be three years.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma, Obesity, Breathing exercise
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Interventional
Arm Type
Experimental
Arm Description
Participants will receive standard asthmatic treatment and breathing/mild physical exercise
Arm Title
Control Arm
Arm Type
No Intervention
Arm Description
The control arm will receive standard medical care for asthma
Intervention Type
Other
Intervention Name(s)
Exercise
Other Intervention Name(s)
Deep breathing and mild physical exercise
Intervention Description
Participants will perform 2-4 sessions of the prescribed exercise every day (One session: deep breathing 5-10 times; upper body stretching 5-10 times).
Primary Outcome Measure Information:
Title
Change in Post-bronchodilator Forced Expired Volume in one second (FEV1)
Description
Investigators are expecting positive changes (improvement) in Forced Expired Volume in one second (FEV1) over the course of time. FEV1 is an indicator of improvement in the lung functions and, therefore, asthma control.
Time Frame
At baseline (pre-exercise) and two different time points (3 and 6 months of post-exercise)
Secondary Outcome Measure Information:
Title
Improvement in other pulmonary functions as well as quality of life assessment
Description
Other pulmonary function tests will be measured for the assessment of pulmonary function. A standard Asthma Control Questionnaire will be used to measure improvement in the quality of life
Time Frame
At baseline (pre-exercise) and two different time points (3 and 6 months of post-exercise)
Title
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)
Title
Change in Immunological Markers
Description
To determine how the protocol specific intervention affects Immunological Markers.
Time Frame
At baseline (pre-exercise) and two different time points (3 and 6 months of post-exercise)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rasheed Ahmad, PhD
Organizational Affiliation
Principal Investigator, Dasman Diabetes Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fahad Al-Ghimlas, MD
Organizational Affiliation
Co-Principal Investigator, Dasman Diabetes Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dasman Diabetes Institute
City
Kuwait
ZIP/Postal Code
15462
Country
Kuwait
12. IPD Sharing Statement
Plan to Share IPD
No
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Breathing & Mild Physical Exercise Therapy for Asthma
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