Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01509443 |
| Other study ID # |
RA-2011-015 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 2012 |
| Est. completion date |
December 2019 |
Study information
| Verified date |
August 2021 |
| Source |
Dasman Diabetes Institute |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
