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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Liege

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

asthmatic patient

aged 18- 65 years

ACQ > 1.5

stable background treatment comprising at least one inhaled corticosteroid or an anti-leukotriene

Disqualifiers

IMC > 35

severe osteoarthritis of the knees and hips

unstable angor

Severe uncontrolled hypertension

Trial design

Design model

Parallel

Treatments tested in this trial

  • Aerobic exercise training

    Other intervention

    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.

  • Respiratory physiotherapy

    Other intervention

    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.

Treatment groups

100 Participants
are divided into 3 treatment groups
Group A: respiratory physiotherapyActive comparator 1 intervention
Group B: control groupNo intervention 0 interventions
Group C: Aerobic exercise trainingOther 1 intervention

Trial outcomes

Primary outcomes

1

Vo2max (maximum oxygen consumption)

change from baseline Vo2Max at 3 months

Time frame
3 months

Secondary outcomes

1

Asthma Quality of Life Questionnaire (AQLQ)

A disease-specific health-related quality of life instrument that taps both physical and emotional impact of disease 32 items with 2-week recall, 4 different domains : Symptoms (11 items), Activity Limitation (12 items, 5 of which are individualized), Emotional Function (5 items), and Environmental Exposure (4 items) 7-point Likert scale (7 = not impaired at all - 1 = severely impaired) Scores range 1-7, with higher scores indicating better quality of life. Change from Baseline AQLQ at 3 months

Time frame
3 months
2

FEV1 (Forced Expiratory volume in 1 second)

Change from Baseline FEV1 at 3 months

Time frame
3 months
3

Asthma control test (ACT)

change from baseline A questionnaire to determine if patient's asthma symptoms are well controlled. A score varying between 1 and 5 is assigned to each question. A score varying between 1 and 5 is assigned to each question. The higher the total score, the better the asthma is controlled From 1 to 14 : Uncontrolled asthma From 15 to 19 : Partially Controlled Asthma From 20 to 25 : Well controlled asthma

Time frame
3 months
4

Hospital Anxiety and depression scale (HAD)

The questionnaire comprises seven questions for anxiety and seven questions for depression For each item, 4 response modes coded from 0 to 3. The anxiety and depression items are alternating. In addition, an alteration in the order of the ratings was carried out to avoid biases linked to their repetition. An overall score is calculated by adding the 14 items but also 2 subtotals corresponding to the 2 subscales. The higher the scores, the higher the symptomatology. From 0 to 7 : absence of anxiety disorders and depressive disorders From 8 to 10 : anxiety and depressive disorders suspected From 11 to 21 : severe anxiety and depressive disorders

Time frame
3 months

Other outcomes

1

maximal inspiratory power

Measured in KPa Change from baseline

Time frame
3 months
2

maximal expiratory power

Measured in KPa Change from baseline

Time frame
3 months
3

maximum isometric force of the quadriceps

measured using a dynamometer Change from baseline

Time frame
3 months
4

VOCs

volatils organics compounds change from baseline

Time frame
3 months

Sponsors and contacts

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