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Recruiting NCT04395937

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

No phase Interventional Chronic Asthma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Aerobic exercise training, Respiratory physiotherapy.
Who it may be relevant to
Registry conditions: Chronic Asthma. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • 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) previous
  • 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.

Primary outcome measures

  • Vo2max (maximum oxygen consumption) [Time frame: 3 months]
Secondary outcome measures (10)
  • Asthma Quality of Life Questionnaire (AQLQ) [Time frame: 3 months]
  • FEV1 (Forced Expiratory volume in 1 second) [Time frame: 3 months]
  • Asthma control test (ACT) [Time frame: 3 months]
  • Hospital Anxiety and depression scale (HAD) [Time frame: 3 months]
  • sputum cell counts [Time frame: 3 months]
  • FeNo (fractional exhaled nitric oxide) [Time frame: 3 months]
  • FVC (Forced Vital Capacity) [Time frame: 3 months]
  • Amount of eosinophils and neutrophils in sputum [Time frame: 3 months]
  • Asthma Control Questionnaire (ACQ) [Time frame: 3 months]
  • PMA (Maximum aerobic power) [Time frame: 3 months]

Eligibility criteria

Inclusion criteria

  • asthmatic patient
  • aged 18- 65 years
  • ACQ > 1.5
  • stable background treatment comprising at least one inhaled corticosteroid or an anti-leukotriene

Exclusion criteria

  • IMC > 35
  • severe osteoarthritis of the knees and hips
  • unstable angor
  • Severe uncontrolled hypertension

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

Belgium · 1 center
  • Chu Liege — Liège

Identifiers

NCT: NCT04395937 · B707202042981

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗