Breathing & Mild Physical Exercise Therapy for Asthma
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.
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Application of Breathing Exercise Program to Improve Asthma in Obese Patients: Effects on Clinico-immunological Parameters|
- 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) ] [ Designated as safety issue: No ]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.
- 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) ] [ Designated as safety issue: No ]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) [ Time Frame: At baseline (pre-exercise) and two diiferent time points (3 and 6 months of post-exercise) ] [ Designated as safety issue: No ]
- Change in Immunological Markers [ Time Frame: At baseline (pre-exercise) and two different time points (3 and 6 months of post-exercise) ] [ Designated as safety issue: No ]To determine how the protocol specific intervention affects Immunological Markers.
|Study Start Date:||April 2012|
|Estimated Study Completion Date:||March 2015|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Participants will receive standard asthmatic treatment and breathing/mild physical exercise
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).
Other Name: Deep breathing and mild physical exercise
No Intervention: Control Arm
The control arm will receive standard medical care for asthma
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01509443
|Contact: Fahad Al-Ghimlas, MD||965 2224 2999 ext firstname.lastname@example.org|
|Contact: Rasheed Ahmad, PhD||+965 2224 2999 ext email@example.com|
|Dasman Diabetes Institute||Recruiting|
|Kuwait, Kuwait, 15462|
|Contact: Fahad Al-Ghimlas, MD 965 2224 2999 ext 4909 firstname.lastname@example.org|
|Contact: Rasheed Ahmad, PhD 965 2224 2999 ext 4311 email@example.com|
|Sub-Investigator: Amal Hasan, PhD|
|Sub-Investigator: Cynthia Lehe, MSc|
|Principal Investigator:||Rasheed Ahmad, PhD||Principal Investigator, Dasman Diabetes Institute|
|Principal Investigator:||Fahad Al-Ghimlas, MD||Co-Principal Investigator, Dasman Diabetes Institute|