An interventional study of Aerobic exercise in Late-Onset Asthma, sponsored by Rigshospitalet, Denmark. Terminated at 1 site in Denmark. Open to female participants aged 45 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-06-23.
Sponsored by Rigshospitalet, Denmark · Not applicable, Interventional, and Treatment
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.
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.
3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.
This study's enrollment of 12 is below the median of 83 across 2,752 interventional studies indexed under Asthma.
Browse Asthma studies →Rigshospitalet, Denmark is the lead sponsor of 1,017 studies on the registry; 183 are open to participants now.
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Exclusion Criteria:
Aerobic exercise by high intensity interval training, 3 times per week for 12 weeks
Behavioral: Aerobic exercise
No intervention for 12 weeks
High Intensity Interval Training (HIIT)
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)
Time frame: -21 to 0 days before intervention and 0 to 14 days post intervention
Heart Rate Variability
Changes in: - Heart rate variability
Time frame: -21 to 0 days before intervention and 0 to 14 days post intervention
Heart rhytm
Changes in: - Heart rhythm
Time frame: -21 to 0 days before intervention and 0 to 14 days post intervention
Heart Rate
Changes in: - electrocardiography
Time frame: -21 to 0 days before intervention and 0 to 14 days post intervention
Heart function - Strain
Measured by stress-echocardiography - Strain
Time frame: -21 to 0 days before intervention and 0 to 14 days post intervention
Heart function - Ejection fraction
Measured by stress-echocardiography - Ejection fraction
Time frame: -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
Time frame: -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
Time frame: -21 to 0 days before intervention and 0 to 14 days post intervention
Heart function - Pulmonary pressure
Measured by stress-echocardiography - Pulmonary pressure
Time frame: -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
Time frame: -21 to 0 days before intervention and 0 to 14 days post intervention
Heart function - Blood pressure
Blood pressure
Time frame: -21 to 0 days before intervention and 0 to 14 days post intervention
Heart function - Cardiac output
Cardiac output
Time frame: -21 to 0 days before intervention and 0 to 14 days post intervention
Heart function - Stroke volume
Stroke volume
Time frame: -21 to 0 days before intervention and 0 to 14 days post intervention
Heart function - Total peripheral resistance
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
Changes in - Leukocytes + differential cell count count
Time frame: -21 to 0 days before intervention and 0 to 14 days post intervention
Systemic inflammation - Interleukin 6
Changes in - Interleukin 6
Time frame: -21 to 0 days before intervention and 0 to 14 days post intervention
Systemic inflammation - Interleukin 8
Changes in - Interleukin 8
Time frame: -21 to 0 days before intervention and 0 to 14 days post intervention
Systemic inflammation
Changes in - Other interleukins
Time frame: -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
Time frame: -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
Time frame: -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
Time frame: -21 to 0 days before intervention and 0 to 14 days post intervention
Local airway inflammation - Sputum cell count
Changes in - 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
Changes in - 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
Changes in - Hyperreactivity to inhaled methacholine
Time frame: -21 to 0 days before intervention and 0 to 14 days post intervention
Body Composition
Changes in - Total body fat
Time frame: -21 to 0 days before intervention and 0 to 14 days post intervention
Body Composition
Changes in - Lean body mass
Time frame: -21 to 0 days before intervention and 0 to 14 days post intervention
Body Composition
Changes in - Muscle mass
Time frame: -21 to 0 days before intervention and 0 to 14 days post intervention
Body Composition
Changes in - Weight
Time frame: -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
Time frame: -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.
Time frame: -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.
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)
Changes in - Mini Asthma Quality of Life Questionnaire (miniAQLQ) 7-point Likert scale (7 = not impaired at all - 1 = severely impaired).
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)
Changes in - Hospital Anxiety and Depression Scale (HADS)
Time frame: -21 to 0 days before intervention and 0 to 14 days post intervention
Plan to share: Yes — Data that support the results of this study will be made available immediately, with no end date, after deidentification and upon reasonable request.
This study is terminated, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
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Rigshospitalet, Denmark