An interventional study of Exercise in Asthma, sponsored by Dasman Diabetes Institute. Completed at 1 site in Kuwait. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-08-20.
Sponsored by Dasman Diabetes Institute · Not applicable, Interventional, and Supportive care
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.
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.
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.
4,010 studies on the registry are indexed under Asthma; 514 are open to participants now.
This study's enrollment of 100 is above the median of 83 across 2,814 interventional studies indexed under Asthma.
Browse Asthma studies →Dasman Diabetes Institute is the lead sponsor of 31 studies on the registry; 14 are open to participants now.
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Exclusion Criteria:
Participants will receive standard asthmatic treatment and breathing/mild physical exercise
Other: Exercise
The control arm will receive standard medical care for asthma
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).
Also known as: Deep breathing and mild physical exercise
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.
Time frame: At baseline (pre-exercise) and two different time points (3 and 6 months of post-exercise)
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
Time frame: At baseline (pre-exercise) and two different time points (3 and 6 months of post-exercise)
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)
Change in Immunological Markers
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)
Plan to share: No
No publications or documents are linked to this record.
The record gives a start of Apr 2012, a primary completion of Dec 2017 and a completion of Dec 2019. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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Dasman Diabetes Institute