NCT04395937

SAMBA Trial: Towards a Paradigm Shift in Severe Asthma Management: Deep Analysis of the Effect of suBmaximal Aerobic Training

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University of Liege · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The effects of regular exercise on asthma control has not yet been well demonstrated. The aim of this study is to investigate the impact of submaximal aerobic training on exercise tolerance (VO2max - primary outcome) and a set of secondary outcomes: quality of life, asthma symptoms control, bronchial and systemic inflammatory markers, lung function, bronchial hyperresponsiveness, anxiety and depression and body composition in patients with persistant asthma.

Detailed description

While it is well known that intense physical exercise can generate bronchospasm and limit exercise performance, it recently appeared that regular physical exercise practiced aerobically could improve the clinical status of asthmatic patients. The investigators are planning a 12-week randomized controlled study to assess the effect of regular aerobic exercise on exercise tolerance (VO2max), quality of life, asthma control, lung function, bronchial hyperresponsiveness, anxiety and depression, and bronchial and systemic inflammation in patients with persistent asthma. The hypothesis is that regular physical exercise increases exercise tolerance, symptoms control, lung function and quality of life and reduces inflammation, anxiety and depression and bronchial hyperresponsiveness compared to simple physiotherapy sessions.

Conditions

• Chronic Asthma

Interventions

Type	Name	Description
OTHER	Aerobic exercise training	Arm Description: The aerobic training program will be performed indoor three times a week for 12 weeks, under the direct supervision of a chest physician and a physiotherapist. Each aerobic training session will last 75 minutes and will be divided in 5 min of warm-up, 60 min of aerobic training (including 20 minutes on three different ergometers: bicycle, treadmill and rower/elliptical trainers) and 10 min of cool-down. Training intensity is determined by the maximal aerobic power (MAP) previously measured during an initial cardiopulmonary exercise test. Progressive increase in training load during the first three weeks (3x20 minutes at 50% of MAP), followed by 3x20 min at 60% of MAP from weeks 4 to 6, then 3x20 min at 70% of MAP from week 7 to week 9. Finally trainings from week 10 to week 12 include one session of interval training and two sessions of continuous training.
OTHER	Respiratory physiotherapy	Arm Description: Exercises to improve the way of breathing. The breathing exercise sessions will last 30 minutes and be supervised by a physiotherapist 3 times per week.

Timeline

• Start date: 2020-09-01
• Primary completion: 2028-09-01
• Completion: 2028-09-01
• First posted: 2020-05-20
• Last updated: 2026-04-14

Locations

1 site across 1 country: Belgium