AsthmaNCT01509443
Breathing & Mild Physical Exercise Therapy for Asthma
A study testing Exercise in people with Asthma, run by Dasman Diabetes Institute at 1 site in Kuwait.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteKuwait
- Study dates
- Apr 2012to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals who report a physician-made diagnosis of asthma
- Non-smokers and ex-smokers (should have stopped smoking at least 1 year ago)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Application of Breathing Exercise Program to Improve Asthma in Obese Patients: Effects on Clinico-immunological Parameters
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.
Read more
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.
Read the 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.
- Conditions
- Asthma
- Being tested
- Exercise
- Keywords
- Asthma, Obesity, Breathing exercise
- Medical subject headings
- Asthma, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Also called Deep breathing and 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).
| Study group | Role | What they receive |
|---|---|---|
| Interventional | Experimental | Participants will receive standard asthmatic treatment and breathing/mild physical exercise Receives: Other: Exercise |
| Control Arm | No intervention | The control arm will receive standard medical care for asthma |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline (pre-exercise) and two different time points (3 and 6 months of post-exercise)
Secondary outcomes (3)
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
Measured: At baseline (pre-exercise) and two different time points (3 and 6 months of post-exercise)
Change in Fraction of exhaled nitric oxide (FeNO)
Measured: 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.
Measured: At baseline (pre-exercise) and two different time points (3 and 6 months of post-exercise)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2012 (estimated)
- Study startApr 2012
- Primary completionDec 2017
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dasman Diabetes Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rasheed Ahmad, PhD, Dasman Diabetes Institute
- Investigators
- Rasheed Ahmad, PhD, Principal investigator, Principal Investigator, Dasman Diabetes InstituteFahad Al-Ghimlas, MD, Principal investigator, Co-Principal Investigator, Dasman Diabetes Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01509443
- Sponsor's protocol ID
- RA-2011-015
- Status last verified
- Aug 2021
- First submitted
- 2 Jan 2012
- Last updated
- 20 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Breathing Exercise Program to Improve Asthma in Obese Patients: Effects on Clinico-immunological Parameters
- ClinicalTrials.gov ID
- NCT01509443
- Acronym / sponsor ID
- RA-2011-015
- Conditions
- Asthma
- Keywords
- Asthma, Obesity, Breathing exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Dasman Diabetes InstituteUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 13 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional | Experimental | Other: ExerciseParticipants will receive standard asthmatic treatment and breathing/mild physical exercise |
| Control Arm | No intervention | –The control arm will receive standard medical care for asthma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Individuals who report a physician-made diagnosis of asthma
- Non-smokers and ex-smokers (should have stopped smoking at least 1 year ago)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseAlso: Deep breathing and mild physical exerciseParticipants 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 | Interventional |
Primary outcome
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)
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.
3 secondary outcomes
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)
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
Time frame: At baseline (pre-exercise) and two different time points (3 and 6 months of post-exercise)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rasheed Ahmad, PhD principal investigator
Principal Investigator, Dasman Diabetes Institute
Fahad Al-Ghimlas, MD principal investigator
Co-Principal Investigator, Dasman Diabetes Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Asthma, run by Dasman Diabetes Institute at 1 site in Kuwait.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kuwait. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2021.