Clinical trial NCT01509443: 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
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: Asthma
Obesity
Breathing exercise
Lead sponsor: Dasman Diabetes Institute
Sponsor class: OTHER
First posted: 2012-01-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

1. To assess the improvement of asthma control, lung function and airways hyper-reactivity after the intervention.
2. To test if the proposed intervention will result in the improvement of pro-inflammatory profiles.
3. 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.

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

Primary outcomes:
measure: Change in Post-bronchodilator Forced Expired Volume in one second (FEV1)
timeFrame: At baseline (pre-exercise) and two different time points (3 and 6 months of post-exercise)
Secondary outcomes:
measure: Improvement in other pulmonary functions as well as quality of life assessment
timeFrame: At baseline (pre-exercise) and two different time points (3 and 6 months of post-exercise)
measure: Change in Fraction of exhaled nitric oxide (FeNO)
timeFrame: At baseline (pre-exercise) and two diiferent time points (3 and 6 months of post-exercise)
measure: Change in Immunological Markers
timeFrame: At baseline (pre-exercise) and two different time points (3 and 6 months of post-exercise)
Other outcomes:
Locations:
city: Kuwait
country: Kuwait
facility: Dasman Diabetes Institute
Study officials:
affiliation: Principal Investigator, Dasman Diabetes Institute
name: Rasheed Ahmad, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Co-Principal Investigator, Dasman Diabetes Institute
name: Fahad Al-Ghimlas, MD
role: PRINCIPAL_INVESTIGATOR
References: