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Asthma Severity in Women: The Influence of Training and Menopause (ATOM)

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ClinicalTrials.gov Identifier: NCT03747211
Recruitment Status : Recruiting
First Posted : November 20, 2018
Last Update Posted : March 21, 2019
Sponsor:
Information provided by (Responsible Party):
Vibeke Backer, Bispebjerg Hospital

Brief 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 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.


Condition or disease Intervention/treatment Phase
Late-Onset Asthma Behavioral: Aerobic exercise Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, outcome assessor blinded, controlled trial
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: Concealed computer generated allocation via REDCap
Primary Purpose: Treatment
Official Title: The ATOM Study: Asthma Severity in Women: The Influence of Training and Menopause
Actual Study Start Date : February 12, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Aerobic exercise intervention
Aerobic exercise by high intensity interval training, 3 times per week for 12 weeks
Behavioral: Aerobic exercise
High Intensity Interval Training (HIIT)

No Intervention: Control group
No intervention for 12 weeks



Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Heart Rate Variability [ Time Frame: -21 to 0 days before intervention and 0 to 14 days post intervention ]

    Changes in:

    - Heart rate variability


  2. Heart rhytm [ Time Frame: -21 to 0 days before intervention and 0 to 14 days post intervention ]

    Changes in:

    - Heart rhythm


  3. Heart Rate [ Time Frame: -21 to 0 days before intervention and 0 to 14 days post intervention ]

    Changes in:

    - electrocardiography


  4. Heart function - Strain [ Time Frame: -21 to 0 days before intervention and 0 to 14 days post intervention ]

    Measured by stress-echocardiography

    - Strain


  5. Heart function - Ejection fraction [ Time Frame: -21 to 0 days before intervention and 0 to 14 days post intervention ]

    Measured by stress-echocardiography

    - Ejection fraction


  6. Heart function - Tricuspid annular plane systolic excursion [ Time Frame: -21 to 0 days before intervention and 0 to 14 days post intervention ]

    Measured by stress-echocardiography

    - Tricuspid annular plane systolic excursion


  7. Heart function - Right ventricular function [ Time Frame: -21 to 0 days before intervention and 0 to 14 days post intervention ]

    Measured by stress-echocardiography

    - Right ventricular function


  8. Heart function - Pulmonary pressure [ Time Frame: -21 to 0 days before intervention and 0 to 14 days post intervention ]

    Measured by stress-echocardiography

    - Pulmonary pressure


  9. Heart function - Lung covered cor [ Time Frame: -21 to 0 days before intervention and 0 to 14 days post intervention ]

    Measured by stress-echocardiography

    - Lung covered cor


  10. Heart function - Blood pressure [ Time Frame: -21 to 0 days before intervention and 0 to 14 days post intervention ]
    Blood pressure

  11. Heart function - Cardiac output [ Time Frame: -21 to 0 days before intervention and 0 to 14 days post intervention ]
    Cardiac output

  12. Heart function - Stroke volume [ Time Frame: -21 to 0 days before intervention and 0 to 14 days post intervention ]
    Stroke volume

  13. Heart function - Total peripheral resistance [ Time Frame: -21 to 0 days before intervention and 0 to 14 days post intervention ]
    Total peripheral resistance

  14. Systemic inflammation - Leukocytes + differential cell count count [ Time Frame: -21 to 0 days before intervention and 0 to 14 days post intervention ]

    Changes in

    - Leukocytes + differential cell count count


  15. Systemic inflammation - Interleukin 6 [ Time Frame: -21 to 0 days before intervention and 0 to 14 days post intervention ]

    Changes in

    - Interleukin 6


  16. Systemic inflammation - Interleukin 8 [ Time Frame: -21 to 0 days before intervention and 0 to 14 days post intervention ]

    Changes in

    - Interleukin 8


  17. Systemic inflammation [ Time Frame: -21 to 0 days before intervention and 0 to 14 days post intervention ]

    Changes in

    - Other interleukins


  18. Systemic inflammation - Tumor Necrosis Factor alpha [ Time Frame: -21 to 0 days before intervention and 0 to 14 days post intervention ]

    Changes in

    - Tumor Necrosis Factor alpha


  19. Systemic inflammation - Total immunoglobulin E, Specific immunoglobulin E [ Time Frame: -21 to 0 days before intervention and 0 to 14 days post intervention ]

    Changes in

    • Total immunoglobulin E
    • Specific immunoglobulin E

  20. Systemic inflammation - high sensitivity c reactive protein [ Time Frame: -21 to 0 days before intervention and 0 to 14 days post intervention ]

    Changes in

    - high sensitivity c reactive protein


  21. Local airway inflammation - Sputum cell count [ Time Frame: -21 to 0 days before intervention and 0 to 14 days post intervention ]

    Changes in

    - Sputum cell count


  22. Local airway inflammation - Fraction of exhaled nitric oxide [ Time Frame: -21 to 0 days before intervention and 0 to 14 days post intervention ]

    Changes in

    - Fraction of exhaled nitric oxide


  23. Local airway inflammation - Hyperreactivity to inhaled methacholine [ Time Frame: -21 to 0 days before intervention and 0 to 14 days post intervention ]

    Changes in

    - Hyperreactivity to inhaled methacholine


  24. Body Composition [ Time Frame: -21 to 0 days before intervention and 0 to 14 days post intervention ]

    Changes in

    - Total body fat


  25. Body Composition [ Time Frame: -21 to 0 days before intervention and 0 to 14 days post intervention ]

    Changes in

    - Lean body mass


  26. Body Composition [ Time Frame: -21 to 0 days before intervention and 0 to 14 days post intervention ]

    Changes in

    - Muscle mass


  27. Body Composition [ Time Frame: -21 to 0 days before intervention and 0 to 14 days post intervention ]

    Changes in

    - Weight


  28. Microbiome [ Time Frame: -21 to 0 days before intervention and 0 to 14 days post intervention ]
    Changes in the microbiota in sputum, oral cavity and nasal cavity before and after the training intervention

  29. Compliance - Foster score [ Time Frame: -21 to 0 days before intervention and 0 to 14 days post intervention ]

    Change in

    - Foster score Answers describe last weeks medicine use. Answers range form 0/7 - 7/7 with low values being worse.


  30. Other asthma related questionnaires - Nijmegen questionnaire [ Time Frame: -21 to 0 days before intervention and 0 to 14 days post intervention ]

    Changes in

    - Nijmegen questionnaire Values range from 0-64 and values below 20 are considered normal.


  31. 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 ]

    Changes in

    - Mini Asthma Quality of Life Questionnaire (miniAQLQ) 7-point Likert scale (7 = not impaired at all - 1 = severely impaired).


  32. 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 ]

    Changes in

    - Hospital Anxiety and Depression Scale (HADS)




Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03747211


Contacts
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Contact: Erik Hansen, MD +4530914754 eriksorenhalvardhansen@gmail.com

Locations
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Denmark
Respiratory research unit, Bispebjerg University Hospital Recruiting
Copenhagen, Denmark, 2400
Contact: Vibeke Backer, DmSci, md, prof.    +45 35313069    backer@dadlnet.dk   
Sponsors and Collaborators
Bispebjerg Hospital
Investigators
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Principal Investigator: Vibeke Backer, Physician Respiratory Research Unit, Bispebjerg Hospital

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Responsible Party: Vibeke Backer, Professor, Dr.med, Bispebjerg Hospital
ClinicalTrials.gov Identifier: NCT03747211     History of Changes
Other Study ID Numbers: ATOM
First Posted: November 20, 2018    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases