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The Impact of Varying Exercise Training Intensity on Clinical Asthma Outcomes and Inflammation in Adults with Asthma

The Impact of Varying Exercise Training Intensity on Clinical Asthma Outcomes and Inflammation in Adults with Asthma: A Randomised Controlled Trial

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12617000991314
Acronym
ETA Study
Enrollment
46
Registered
2017-07-10
Start date
2017-07-19
Completion date
2019-08-07
Last updated
2021-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Purpose of Study It is well known that exercise has numerous health benefits; however, research regarding the effect of exercise on airway inflammation in asthma is scarce. This project will examine the clinical and inflammatory impact of three months of exercise training in adults with asthma. This study will also determine whether this effect varies with exercise intensity. This research is highly significant for asthma management, as those with asthma have been shown to have low exercise levels, possibly stemming from the belief that exercise will worsen asthma. Increasing exercise may reduce the reliance on inhaled corticosteroid medication and offer better asthma control, by reducing inflammation. Hypothesis Exercise training will improve clinical asthma outcomes by reducing eosinophilic airway inflammation in adults with asthma. The beneficial effects of exercise in this setting are only evident with moderate-intensity exercise training. Aims 1. To examine the effects of three months of exercise training on asthma outcomes (quality of life, asthma control, asthma exacerbations, airway hyperresponsiveness, and airway and systemic inflammation); 2. To determine whether, and how, these effects vary by exercise intensity.

Interventions

Screening Visit: Participants will be screened for study eligibility. This visit will include medical history, medication usage, height, weight, lung function, asthma control, exhaled nitric oxide (eNO), blood pressure and the ESSA pre-exercise screening questionnaire. This visit should take less than one hour to complete. Once eligibility has been confirmed, participants will be provided with an accelerometer to wear for 7 days and a semi-quantitative food diary to complete for four days prior

Screening Visit: Participants will be screened for study eligibility. This visit will include medical history, medication usage, height, weight, lung function, asthma control, exhaled nitric oxide (eNO), blood pressure and the ESSA pre-exercise screening questionnaire. This visit should take less than one hour to complete. Once eligibility has been confirmed, participants will be provided with an accelerometer to wear for 7 days and a semi-quantitative food diary to complete for four days prior to Visit 1. Visit 1a: Participants will be instructed to abstain from moderate- and vigorous-intensity exercise for the two days prior, and all activity for 12 hours prior to Visit 1. Participants will be instructed to withhold their asthma medications for 6-24 hours and anti-histamine medications for 5 days. Participants will need to fast for at least 12 hours prior to their visit. On arrival to the clinic participants will have their accelerometer and food diary collected, their weight checked and a venous blood sample collected. Fractional exhaled nitric oxide (FeNO) will be measured and spirometry performed. Sputum induction coupled with bronchial provocation will be performed over a standardised 15.5 minutes nebuliser time using 4.5% hypertonic saline. Body composition and bone density will be measured by dual-energy x-ray absorptiometry (DXA). Skin allergy testing will be completed for a panel of common environmental allergens (dust mite, grass, cockroach, moulds) and asthma, exercise and dietary questionnaires will be completed. This visit should take approximately 2.5 hours to complete and will be conducted by a research assistant or postdoctoral research fellow with experience in performing these procedures. Visit 1b: At a separate appointment, VO2max testing will be conducted at The University of Newcastle campus by an exercise physiology intern with training in conducting VO2max measurements. Participants will perform a progressive exercise test on a treadmill. The test commences at an easy workload and becomes progressively harder each minute until the participant voluntarily ends the test or they reach pre-determined end criteria (e.g. HR target; R>1.15). Throughout the test, heart rate, oxygen consumption and ventilation are monitored continuously. In order to measure oxygen consumption and ventilation, participants wear a face mask and their expired air is sampled for analysis. The face mask allows participants to speak clearly so communication throughout the test is maintained. Participants can end the test at any stage. Following VO2max testing, participants randomisation will be revealed. Participants will be randomised to complete either: a) Three months of moderate-intensity exercise training, including at least 3 one hour exercise sessions/week involving activities that maintain heart rate between 55-70% HRmax; or b) Three months of vigorous-intensity exercise training, including at least 3 one hour exercise sessions/week involving activities that maintain heart rate between 70-85% HRmax; or c) Three months of the control condition (no intervention). Visits 2a and 2b: Participants will return to the clinic following the three month intervention, to repeat all procedures completed during Visit 1a and 1b. Prior to these visits, participants will be instructed to wear an accelerometer for one week and complete a 4-day semi-quantitative food diary. Participant Weekly Questionnaires Participants will complete the ACQ6 and quantify their physical activity participation for the preceding week in an online questionnaire to be completed each week. This will assist with monitoring adherence to the intervention protocols. Exercise Protocol Participants will undertake three months of exercise training at The University of Newcastle campus. Participants will be required to complete three x 1 hour exercise sessions per week, with all sessions to be supervised to encourage attendance and compliance with maintaining the appropriate heart rate for each session. These one-on-one sessions will be supervised by exercise physiology intern students. Heart rate will be monitored and recorded throughout the entire session. Moderate-intensity exercise training sessions will be completed at 55-70% of HRmax, while vigorous-intensity exercise will be completed at 70-85% of HRmax. Exercise will be personalised to the patients preference of equipment using a combination of treadmills, cycle ergometers and elliptical ergometers. Participants randomised to the control intervention will be offered a pedometer to keep at the conclusion of the study.

Sponsors

Hunter Medical Research Institute
Lead SponsorOther

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 55 Years
Healthy volunteers
No

Inclusion criteria

1. Physician diagnosed asthma 2. Able to provide written informed consent 4. Body mass index (BMI) <=40kg/m2 (due to increased risk of exercise-related complication in those with a BMI >40kg/m2) 5. Not a current smoker (never smoker or quit at least 6 months ago) 6. Post-bronchodilator forced expiratory volume in 1 second (FEV1) >=50% predicted. 7. Deemed suitable for vigorous-intensity exercise by the study coordinator, according to the ESSA “Adult Pre-Exercise Screening Tool”.

Exclusion criteria

1. Asthma is not the primary respiratory diagnosis 2. A moderate exacerbation (oral corticosteroid or antibiotic use) in the past four weeks or severe exacerbation (hospitalisation) in the past three months 3. Participation in a moderate- or vigorous-intensity exercise session within 2 days of the scheduled study visits. 4. Known cardiac condition contraindicated for exercise 5. Musculoskeletal contraindication to exercise 6. Uncontrolled hypertension (blood pressure >180/100mmHg) 7. Cancer 8. Diabetes mellitus 9. Taking cholesterol lowering medication 10. Pregnancy or breastfeeding 11. Resting SpO2 <=95% on room air 12. Participation in an interventional research study in the last four weeks 13. Currently exercising at a moderate-intensity or greater for >90 mins/week 14. Subject has a clinically important medical illness (including serious psychological disorders) likely to interfere with management or participation in the study

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026