Asthma Severity in Women: The Influence of Training and Menopause

NCT03747211 | Terminated DMC

• 1 other identifier: ATOM
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Late-Onset Asthma

Outcome Measures

Primary Outcomes (1)

• 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)

  -21 to 0 days before intervention and 0 to 14 days post intervention

Secondary Outcomes (32)

• Heart Rate Variability

  -21 to 0 days before intervention and 0 to 14 days post intervention

• Heart rhytm

  -21 to 0 days before intervention and 0 to 14 days post intervention

• Heart Rate

  -21 to 0 days before intervention and 0 to 14 days post intervention

• Heart function - Strain

  -21 to 0 days before intervention and 0 to 14 days post intervention

• Heart function - Ejection fraction

  -21 to 0 days before intervention and 0 to 14 days post intervention

Study Arms (2)

Aerobic exercise intervention

EXPERIMENTAL

Aerobic exercise by high intensity interval training, 3 times per week for 12 weeks

Behavioral: Aerobic exercise

Control group

NO INTERVENTION

No intervention for 12 weeks

Interventions

Aerobic exercise BEHAVIORAL

High Intensity Interval Training (HIIT)

Aerobic exercise intervention

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Respiratory research unit, Bispebjerg University Hospital

Copenhagen, 2400, Denmark

Location

Related Publications (2)

• 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.

  PMID: 37674777 DERIVED

• Hansen 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.

  PMID: 33888532 DERIVED

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Vibeke Backer, Physician

  Respiratory Research Unit, Bispebjerg Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Concealed computer generated allocation via REDCap
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Dr.med

Model Details: Randomized, outcome assessor blinded, controlled trial

Study Record Dates

• First Submitted: November 9, 2018
• First Posted: November 20, 2018
• Study Start: February 12, 2019
• Primary Completion: May 1, 2021
• Study Completion: May 1, 2021
• Last Updated: June 23, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will share
• Time Frame: Immediately after publication with no end date.
• Access Criteria: Data will be made available upon reasonable request to achieve the aims of the reasonable request.

Locations

DK (1)