Late-Onset AsthmaATOMNCT03747211
Asthma Severity in Women: The Influence of Training and Menopause
A study testing Aerobic exercise in people with Late-Onset Asthma, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
Introduction: Late-onset asthma in women is characterized by poor disease control and reduced quality of life despite intensive treatment with inhaled steroid and beta2-agonist. The condition is further worsened at menopause due to the loss of estrogen leading to increased asthma exacerbation frequency, increased… Read more about this study
- Who is it for?
- Ages 45 to 75 years, women only
- Conditions the study is for
- Late-Onset Asthma
- What is being tested?
- Aerobic exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteDenmark
- Study dates
- 12 Feb 2019to 1 May 2021
- 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 45 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Late onset asthma (Debut ≥ 16 years of age)
- ACQ ≥ 1.25
- Daily treatment for asthma (GINA 2 and above)
- Age 45 - 75
- Postmenopausal defined as no menstruation for 6 months, Serum Follicle stimulating hormone >20 International Units per Liter and P-Estradiol nmol/L <0.09
- BMI 25 - 35
Show all 9Show fewer
- Positive bronchial challenge to methacholine, mannitol or positive reversibility to beta2-agonist now or historically
- Untrained (no participation in vigorous exercise for more than 1 hour per week during the last 2 months)
- Capable of exercising on a bike
Who cannot join
- Unable to speak and understand Danish or English.
- Current or former smokers (>6 months cessation) with >20 years of daily smoking with 20 cigarettes per day.
- Other respiratory disease of clinical significance
- Cardiovascular: Unstable ischemic heart disease, myocardial infarction within the last 12 months, symptomatic heart failure (EF <40%), symptomatic heart arrhythmia (documented with ECG), uncontrolled hypertension (>155/100)
- Any disorder that is not stable and in the opinion of the investigator could affect the safety of the subject throughout the study
- Subjects, who by investigators determination, will not be able to adhere to study protocol
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Respiratory research unit, Bispebjerg University Hospital
Copenhagen, 2400
About this study
Official title: The ATOM Study: Asthma Severity in Women: The Influence of Training and Menopause
Introduction: Late-onset asthma in women is characterized by poor disease control and reduced quality of life despite intensive treatment with inhaled steroid and beta2-agonist. The condition is further worsened at menopause due to the loss of estrogen leading to increased asthma exacerbation frequency, increased airway inflammation and decreased lung function. Exercise training may increase disease control of asthma patients, but to what extent the same effect is seen in postmenopausal women with late-onset asthma is unknown. These asthma patients represent a phenotype that is characterized by low eosinophilic airway inflammation, severe symptoms, moderate obesity and poor response to conventional medicine. Thus, our hypothesis is that regular physical exercise is especially associated with an improvement in asthma control in this phenotype. The aim of this project is to test this hypothesis and to assess whether an improvement is associated with reduced local and systemic inflammation, change in heart function, lung function and/or body composition.
Study design: 40 postmenopausal women with late-onset asthma are recruited via the outpatient clinic at the Respiratory Department at Bispebjerg Hospital and through advertisement. The participants are randomized 1:1 into two groups. One group performs supervised exercise training (spinning) three times per week for 12 weeks while the other group is a control group. Before and after the intervention asthma control, local and systemic inflammation, heart function and body composition is measured.
Read more
Results: Analysis will be performed to detect changes within and between the groups before and after intervention. Primary outcome is change in ACQ (Asthma Control Questionnaire). Local and systemic inflammation is measured by changes in bronchial challenge to methacholine, sputum cell count and blood tests. Furthermore, secondary outcomes include change in heart function measured by stress-echocardiography and change in body composition measured by Dual-energy X-ray absorptiometry (DEXA).
Conclusion: There are to date no prospective studies that can support recommendations containing asthma rehabilitation with supervised regular physical activity for postmenopausal women. Thus, this study will provide novel understanding of the importance of physical activity in a chronic disease such as asthma.
Read the detailed description
Overall study design
The study is a single-blinded randomized controlled intervention study. Forty postmenopausal women with late-onset asthma (>16 years at debut) are recruited from the asthma outpatient-clinic at Bispebjerg Hospital or other hospital/practitioner in the region and/or by advertisement. The participants are block-randomized into two groups of 20, where one group is control and the other undergoes a period of regular exercise training. The investigators will be blinded and will not know whether the subjects have trained or not.
Detailed study design
Participants allocated to the exercise training group undergo a training intervention consisting of 45 minutes of intermittent high intensity aerobic spinning training three times per week for 12 weeks. Participants allocated to the control group will continue usual care without training. No changes to current treatment will be made by the investigators on any of the groups.
The training will consist of short periods of high intensity intervals where subjects reach above 80% of maximal oxygen consumption. Spinning sessions will be fully supervised by trained instructors with a bachelor of sports and science or bachelor of medicine and conducted in the Department of Nutrition, Exercise and Sports, University of Copenhagen. Subjects will wear heart rate monitors to ensure adherence to the training protocol. Within two weeks, before and after the intervention, participants from both groups undergo 3 days of testing.
To ensure equal compliance with asthma medication both groups will receive daily electronic reminders. Once a week, all participants will be asked about their compliance to their medication.
- Conditions
- Late-Onset Asthma
- Being tested
- Aerobic exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exerciseBehavioural
High Intensity Interval Training (HIIT)
| Study group | Role | What they receive |
|---|---|---|
| Aerobic exercise intervention | Experimental | Aerobic exercise by high intensity interval training, 3 times per week for 12 weeks Receives: Behavioral: Aerobic exercise |
| Control group | No intervention | No intervention for 12 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asthma control - Asthma Control Questionnaire (ACQ)
Changes in Asthma Control Questionnaire (ACQ) 7-point scale (0=no impairment, 6= maximum impairment for symptoms and rescue use)
Measured: -21 to 0 days before intervention and 0 to 14 days post intervention
Secondary outcomes (32)
Heart Rate Variability
Changes in:
- Heart rate variability
Measured: -21 to 0 days before intervention and 0 to 14 days post intervention
Heart rhytm
Changes in:
- Heart rhythm
Measured: -21 to 0 days before intervention and 0 to 14 days post intervention
Heart Rate
Changes in:
- electrocardiography
Measured: -21 to 0 days before intervention and 0 to 14 days post intervention
Heart function - Strain
Measured by stress-echocardiography
- Strain
Measured: -21 to 0 days before intervention and 0 to 14 days post intervention
Heart function - Ejection fraction
Measured by stress-echocardiography
- Ejection fraction
Measured: -21 to 0 days before intervention and 0 to 14 days post intervention
Heart function - Tricuspid annular plane systolic excursion
Measured by stress-echocardiography
- Tricuspid annular plane systolic excursion
Measured: -21 to 0 days before intervention and 0 to 14 days post intervention
Heart function - Right ventricular function
Measured by stress-echocardiography
- Right ventricular function
Measured: -21 to 0 days before intervention and 0 to 14 days post intervention
Heart function - Pulmonary pressure
Measured by stress-echocardiography
- Pulmonary pressure
Measured: -21 to 0 days before intervention and 0 to 14 days post intervention
Heart function - Lung covered cor
Measured by stress-echocardiography
- Lung covered cor
Measured: -21 to 0 days before intervention and 0 to 14 days post intervention
Heart function - Blood pressure
Blood pressure
Measured: -21 to 0 days before intervention and 0 to 14 days post intervention
Heart function - Cardiac output
Cardiac output
Measured: -21 to 0 days before intervention and 0 to 14 days post intervention
Heart function - Stroke volume
Stroke volume
Measured: -21 to 0 days before intervention and 0 to 14 days post intervention
Heart function - Total peripheral resistance
Total peripheral resistance
Measured: -21 to 0 days before intervention and 0 to 14 days post intervention
Systemic inflammation - Leukocytes + differential cell count count
Changes in
- Leukocytes + differential cell count count
Measured: -21 to 0 days before intervention and 0 to 14 days post intervention
Systemic inflammation - Interleukin 6
Changes in
- Interleukin 6
Measured: -21 to 0 days before intervention and 0 to 14 days post intervention
Systemic inflammation - Interleukin 8
Changes in
- Interleukin 8
Measured: -21 to 0 days before intervention and 0 to 14 days post intervention
Systemic inflammation
Changes in
- Other interleukins
Measured: -21 to 0 days before intervention and 0 to 14 days post intervention
Systemic inflammation - Tumor Necrosis Factor alpha
Changes in
- Tumor Necrosis Factor alpha
Measured: -21 to 0 days before intervention and 0 to 14 days post intervention
Systemic inflammation - Total immunoglobulin E, Specific immunoglobulin E
Changes in
- Total immunoglobulin E
- Specific immunoglobulin E
Measured: -21 to 0 days before intervention and 0 to 14 days post intervention
Systemic inflammation - high sensitivity c reactive protein
Changes in
- high sensitivity c reactive protein
Measured: -21 to 0 days before intervention and 0 to 14 days post intervention
Local airway inflammation - Sputum cell count
Changes in
- Sputum cell count
Measured: -21 to 0 days before intervention and 0 to 14 days post intervention
Local airway inflammation - Fraction of exhaled nitric oxide
Changes in
- Fraction of exhaled nitric oxide
Measured: -21 to 0 days before intervention and 0 to 14 days post intervention
Local airway inflammation - Hyperreactivity to inhaled methacholine
Changes in
- Hyperreactivity to inhaled methacholine
Measured: -21 to 0 days before intervention and 0 to 14 days post intervention
Body Composition
Changes in
- Total body fat
Measured: -21 to 0 days before intervention and 0 to 14 days post intervention
Body Composition
Changes in
- Lean body mass
Measured: -21 to 0 days before intervention and 0 to 14 days post intervention
Body Composition
Changes in
- Muscle mass
Measured: -21 to 0 days before intervention and 0 to 14 days post intervention
Body Composition
Changes in
- Weight
Measured: -21 to 0 days before intervention and 0 to 14 days post intervention
Microbiome
Changes in the microbiota in sputum, oral cavity and nasal cavity before and after the training intervention
Measured: -21 to 0 days before intervention and 0 to 14 days post intervention
Compliance - Foster score
Change in
- Foster score Answers describe last weeks medicine use. Answers range form 0/7 - 7/7 with low values being worse.
Measured: -21 to 0 days before intervention and 0 to 14 days post intervention
Other asthma related questionnaires - Nijmegen questionnaire
Changes in
- Nijmegen questionnaire Values range from 0-64 and values below 20 are considered normal.
Measured: -21 to 0 days before intervention and 0 to 14 days post intervention
Other asthma related questionnaires - Mini Asthma Quality of Life Questionnaire (miniAQLQ)
Changes in
- Mini Asthma Quality of Life Questionnaire (miniAQLQ) 7-point Likert scale (7 = not impaired at all - 1 = severely impaired).
Measured: -21 to 0 days before intervention and 0 to 14 days post intervention
Other asthma related questionnaires - Hospital Anxiety and Depression Scale (HADS) 2 items with 7 questions regarding anxiety and depression. (0 = no sign of depression/anxiety, 21 = maximal signs of anxiety/depression)
Changes in
- Hospital Anxiety and Depression Scale (HADS)
Measured: -21 to 0 days before intervention and 0 to 14 days post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2018
- Study start12 Feb 2019
- Primary completion1 May 2021
- Study completion1 May 2021
Why it stopped: Issues recruiting participants during COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Late-Onset AsthmaStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, outcome assessor blinded, controlled trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vibeke Backer, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Vibeke Backer, Physician, Principal investigator, Respiratory Research Unit, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03747211
- Sponsor's protocol ID
- ATOM
- Acronym
- ATOM
- Status last verified
- Jun 2021
- First submitted
- 9 Nov 2018
- Last updated
- 23 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data that support the results of this study will be made available immediately, with no end date, after deidentification and upon reasonable request.
Publications
Hansen ESH, Rasmusen HK, Hostrup M, Hellsten Y, Backer V. The effect of aerobic exercise training on asthma control in postmenopausal women (ATOM): a randomized controlled pilot study. Eur Clin Respir J. 2023 Sep 4;10(1):2251256. doi: 10.1080/20018525.2023.2251256. eCollection 2023.
PubMed 37674777Hansen ESH, Hostrup M, Rasmusen HK, Hellsten Y, Backer V. Effect of aerobic exercise training on asthma control in postmenopausal women (the ATOM-study): protocol for an outcome assessor, randomised controlled trial. BMJ Open. 2021 Apr 22;11(4):e049477. doi: 10.1136/bmjopen-2021-049477.
PubMed 33888532
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The ATOM Study: Asthma Severity in Women: The Influence of Training and Menopause
- ClinicalTrials.gov ID
- NCT03747211
- Acronym / sponsor ID
- ATOM / ATOM
- Conditions
- Late-Onset Asthma
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Issues recruiting participants during COVID-19
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 12 Feb 2019 (actual)
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 20 Nov 2018 (actual)
- 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.
Introduction: Late-onset asthma in women is characterized by poor disease control and reduced quality of life despite intensive treatment with inhaled steroid and beta2-agonist. The condition is further worsened at menopause due to the loss of estrogen leading to increased asthma exacerbation frequency, increased airway inflammation and decreased lung function. Exercise training may increase disease control of asthma patients, but to what extent the same effect is seen in postmenopausal women with late-onset asthma is unknown. These asthma patients represent a phenotype that is characterized by low eosinophilic airway inflammation, severe symptoms, moderate obesity and poor response to conventional medicine. Thus, our hypothesis is that regular physical exercise is especially associated with an improvement in asthma control in this phenotype. The aim of this project is to test this hypothesis and to assess whether an improvement is associated with reduced local and systemic inflammation, change in heart function, lung function and/or body composition.
Study design: 40 postmenopausal women with late-onset asthma are recruited via the outpatient clinic at the Respiratory Department at Bispebjerg Hospital and through advertisement. The participants are randomized 1:1 into two groups. One group performs supervised exercise training (spinning) three times per week for 12 weeks while the other group is a control group. Before and after the intervention asthma control, local and systemic inflammation, heart function and body composition is measured.
Results: Analysis will be performed to detect changes within and between the groups before and after intervention. Primary outcome is change in ACQ (Asthma Control Questionnaire). Local and systemic inflammation is measured by changes in bronchial challenge to methacholine, sputum cell count and blood tests. Furthermore, secondary outcomes include change in heart function measured by stress-echocardiography and change in body composition measured by Dual-energy X-ray absorptiometry (DEXA).
Conclusion: There are to date no prospective studies that can support recommendations containing asthma rehabilitation with supervised regular physical activity for postmenopausal women. Thus, this study will provide novel understanding of the importance of physical activity in a chronic disease such as asthma.
Detailed description
Overall study design
The study is a single-blinded randomized controlled intervention study. Forty postmenopausal women with late-onset asthma (>16 years at debut) are recruited from the asthma outpatient-clinic at Bispebjerg Hospital or other hospital/practitioner in the region and/or by advertisement. The participants are block-randomized into two groups of 20, where one group is control and the other undergoes a period of regular exercise training. The investigators will be blinded and will not know whether the subjects have trained or not.
Detailed study design
Participants allocated to the exercise training group undergo a training intervention consisting of 45 minutes of intermittent high intensity aerobic spinning training three times per week for 12 weeks. Participants allocated to the control group will continue usual care without training. No changes to current treatment will be made by the investigators on any of the groups.
The training will consist of short periods of high intensity intervals where subjects reach above 80% of maximal oxygen consumption. Spinning sessions will be fully supervised by trained instructors with a bachelor of sports and science or bachelor of medicine and conducted in the Department of Nutrition, Exercise and Sports, University of Copenhagen. Subjects will wear heart rate monitors to ensure adherence to the training protocol. Within two weeks, before and after the intervention, participants from both groups undergo 3 days of testing.
To ensure equal compliance with asthma medication both groups will receive daily electronic reminders. Once a week, all participants will be asked about their compliance to their medication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, outcome assessor blinded, controlled trial
| Arm | Type | Receives |
|---|---|---|
| Aerobic exercise intervention | Experimental | Behavioral: Aerobic exerciseAerobic exercise by high intensity interval training, 3 times per week for 12 weeks |
| Control group | No intervention | –No intervention for 12 weeks |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Late onset asthma (Debut ≥ 16 years of age)
- ACQ ≥ 1.25
- Daily treatment for asthma (GINA 2 and above)
- Age 45 - 75
- Postmenopausal defined as no menstruation for 6 months, Serum Follicle stimulating hormone >20 International Units per Liter and P-Estradiol nmol/L <0.09
Key exclusion criteria (6 listed)
- Unable to speak and understand Danish or English.
- Current or former smokers (>6 months cessation) with >20 years of daily smoking with 20 cigarettes per day.
- Other respiratory disease of clinical significance
- Cardiovascular: Unstable ischemic heart disease, myocardial infarction within the last 12 months, symptomatic heart failure (EF <40%), symptomatic heart arrhythmia (documented with ECG), uncontrolled hypertension (>155/100)
- Any disorder that is not stable and in the opinion of the investigator could affect the safety of the subject throughout the study
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 |
|---|---|---|
| Aerobic exerciseHigh Intensity Interval Training (HIIT) | Behavioural | Aerobic exercise intervention |
Primary outcome
Asthma control - Asthma Control Questionnaire (ACQ)
Time frame: -21 to 0 days before intervention and 0 to 14 days post intervention
Changes in Asthma Control Questionnaire (ACQ) 7-point scale (0=no impairment, 6= maximum impairment for symptoms and rescue use)
32 secondary outcomes
Heart Rate Variability
Time frame: -21 to 0 days before intervention and 0 to 14 days post intervention
Heart rhytm
Time frame: -21 to 0 days before intervention and 0 to 14 days post intervention
Heart Rate
Time frame: -21 to 0 days before intervention and 0 to 14 days post intervention
Heart function - Strain
Time frame: -21 to 0 days before intervention and 0 to 14 days post intervention
Heart function - Ejection fraction
Time frame: -21 to 0 days before intervention and 0 to 14 days post intervention
Heart function - Tricuspid annular plane systolic excursion
Time frame: -21 to 0 days before intervention and 0 to 14 days post intervention
Heart function - Right ventricular function
Time frame: -21 to 0 days before intervention and 0 to 14 days post intervention
Heart function - Pulmonary pressure
Time frame: -21 to 0 days before intervention and 0 to 14 days post intervention
Heart function - Lung covered cor
Time frame: -21 to 0 days before intervention and 0 to 14 days post intervention
Heart function - Blood pressure
Time frame: -21 to 0 days before intervention and 0 to 14 days post intervention
Heart function - Cardiac output
Time frame: -21 to 0 days before intervention and 0 to 14 days post intervention
Heart function - Stroke volume
Time frame: -21 to 0 days before intervention and 0 to 14 days post intervention
Heart function - Total peripheral resistance
Time frame: -21 to 0 days before intervention and 0 to 14 days post intervention
Systemic inflammation - Leukocytes + differential cell count count
Time frame: -21 to 0 days before intervention and 0 to 14 days post intervention
Systemic inflammation - Interleukin 6
Time frame: -21 to 0 days before intervention and 0 to 14 days post intervention
Systemic inflammation - Interleukin 8
Time frame: -21 to 0 days before intervention and 0 to 14 days post intervention
Systemic inflammation
Time frame: -21 to 0 days before intervention and 0 to 14 days post intervention
Systemic inflammation - Tumor Necrosis Factor alpha
Time frame: -21 to 0 days before intervention and 0 to 14 days post intervention
Systemic inflammation - Total immunoglobulin E, Specific immunoglobulin E
Time frame: -21 to 0 days before intervention and 0 to 14 days post intervention
Systemic inflammation - high sensitivity c reactive protein
Time frame: -21 to 0 days before intervention and 0 to 14 days post intervention
Local airway inflammation - Sputum cell count
Time frame: -21 to 0 days before intervention and 0 to 14 days post intervention
Local airway inflammation - Fraction of exhaled nitric oxide
Time frame: -21 to 0 days before intervention and 0 to 14 days post intervention
Local airway inflammation - Hyperreactivity to inhaled methacholine
Time frame: -21 to 0 days before intervention and 0 to 14 days post intervention
Body Composition
Time frame: -21 to 0 days before intervention and 0 to 14 days post intervention
Body Composition
Time frame: -21 to 0 days before intervention and 0 to 14 days post intervention
Body Composition
Time frame: -21 to 0 days before intervention and 0 to 14 days post intervention
Body Composition
Time frame: -21 to 0 days before intervention and 0 to 14 days post intervention
Microbiome
Time frame: -21 to 0 days before intervention and 0 to 14 days post intervention
Compliance - Foster score
Time frame: -21 to 0 days before intervention and 0 to 14 days post intervention
Other asthma related questionnaires - Nijmegen questionnaire
Time frame: -21 to 0 days before intervention and 0 to 14 days post intervention
Other asthma related questionnaires - Mini Asthma Quality of Life Questionnaire (miniAQLQ)
Time frame: -21 to 0 days before intervention and 0 to 14 days post intervention
Other asthma related questionnaires - Hospital Anxiety and Depression Scale (HADS) 2 items with 7 questions regarding anxiety and depression. (0 = no sign of depression/anxiety, 21 = maximal signs of anxiety/depression)
Time frame: -21 to 0 days before intervention and 0 to 14 days post intervention
Results and safety
The study was stopped early (reason given: Issues recruiting participants during COVID-19). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2021.
- Derived from this study: PubMed 37674777Hansen ESH, Rasmusen HK, Hostrup M, Hellsten Y, Backer V. The effect of aerobic exercise training on asthma control in postmenopausal women (ATOM): a randomized controlled pilot study. Eur Clin Respir J. 2023 Sep 4;10(1):2251256. doi: 10.1080/20018525.2023.2251256. eCollection 2023.
- Derived from this study: PubMed 33888532Hansen ESH, Hostrup M, Rasmusen HK, Hellsten Y, Backer V. Effect of aerobic exercise training on asthma control in postmenopausal women (the ATOM-study): protocol for an outcome assessor, randomised controlled trial. BMJ Open. 2021 Apr 22;11(4):e049477. doi: 10.1136/bmjopen-2021-049477.
- Individual participant dataSharing planned: Yes. Data that support the results of this study will be made available immediately, with no end date, after deidentification and upon reasonable request.
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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.
Vibeke Backer, Physician principal investigator
Respiratory Research Unit, Bispebjerg Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic exercise in people with Late-Onset Asthma, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 9 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: stopped early, as of the sponsor's last update on 23 Jun 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 Denmark. 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 was stopped early (reason given: Issues recruiting participants during COVID-19). Results are not available in the source record.
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?
Asthma control - Asthma Control Questionnaire (ACQ) (time frame: -21 to 0 days before intervention and 0 to 14 days post intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03747211, which also lists 2 linked publications.
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 23 Jun 2021.