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NCT Number: NCT04395937

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

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.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chu Liege

Liège, Liege, 4000, Belgium

Location status: Recruiting

Location contact

Florence Schleich

SUB_INVESTIGATOR

stephanie ziant

CONTACT

+3243668568

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aerobic exercise training

Other

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

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 outcomes

  1. Vo2max (maximum oxygen consumption)

    Time frame: 3 months

    change from baseline Vo2Max at 3 months

Secondary outcomes

  1. Asthma Quality of Life Questionnaire (AQLQ)

    Time frame: 3 months

    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

  2. FEV1 (Forced Expiratory volume in 1 second)

    Time frame: 3 months

    Change from Baseline FEV1 at 3 months

  3. Asthma control test (ACT)

    Time frame: 3 months

    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

  4. Hospital Anxiety and depression scale (HAD)

    Time frame: 3 months

    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

  5. sputum cell counts

    Time frame: 3 months

    change from baseline

  6. FeNo (fractional exhaled nitric oxide)

    Time frame: 3 months

    change from baseline FENO at 3 months

  7. FVC (Forced Vital Capacity)

    Time frame: 3 months

    FVC is the greatest total amount of air the patient can forcefully breathe out after breathing in as deeply as possible Change from Baseline FVC1 at 3 months

  8. Amount of eosinophils and neutrophils in sputum

    Time frame: 3 months

    Change from baseline in amount of eosinophils and neutrophils in sputum

  9. Asthma Control Questionnaire (ACQ)

    Time frame: 3 months

    A simple questionnaire to measure the adequacy of asthma control and change in asthma control which occurs either spontaneously or as a result of treatment.

    7 items; 1 week recall (for items on symptoms and rescue inhaler use) ACQ has a multidimensional construct assessing symptoms (5 items--self-administered) and rescue bronchodilator use (1 item-self-administered), and FEV1% (1 item) completed by clinic staff 7-point scale (0=no impairment, 6= maximum impairment for symptoms and rescue use; and 7 categories for FEV1%) Scores range between 0 (totally controlled) and 6 (severely uncontrolled). Change from Baseline ACQ at 3 months

  10. PMA (Maximum aerobic power)

    Time frame: 3 months

    change from baseline PMA at 3 months

Other outcomes

  1. maximal inspiratory power

    Time frame: 3 months

    Measured in KPa Change from baseline

  2. maximal expiratory power

    Time frame: 3 months

    Measured in KPa Change from baseline

  3. maximum isometric force of the quadriceps

    Time frame: 3 months

    measured using a dynamometer Change from baseline

  4. VOCs

    Time frame: 3 months

    volatils organics compounds change from baseline

  5. isometric force of long finger grasp

    Time frame: 3 months

    measured using a Jamar dynamometer change from baseline

  6. TLC (Total Lung Capacity)

    Time frame: 3 months

    It is the total volume of air in the lungs after a maximal inspiration change from baseline TLC at 3 months

  7. DLCO (Diffusing Capacity of the Lung for Carbon Monoxide)

    Time frame: 3 months

    Measures the efficiency of the gas transfer characteristics of the lungs change from baseline DLCO at 3 months

  8. PC20M (measures the concentration of metacholine necessary to bring down the FEV1 by 20% compared to its base value)

    Time frame: 3 months

    Change from baseline PC20M at 3 months

  9. KCO (transfer coefficient of the lung for carbon monoxide)

    Time frame: 3 months

    change from baseline KCO at 3 months

  10. FRC (Functional Residual Capacity)

    Time frame: 3 months

    The volume of air present in the lungs at the end of passive expiration Change from baseline FRC at 3 months

  11. RV (Residual Volume)

    Time frame: 3 months

    It is the amount of air remaining in the lungs after a maximal expiration Change from baseline RV at 3 months

  12. fall in FEV1 during ergospirometric measurement

    Time frame: 3 months

    Change from Baseline fall in FEV1 during ergospirometric measurement

  13. sGaw (Specific airway conductance)

    Time frame: 3 months

    Change from baseline sGaw at 3 months

  14. Body composition

    Time frame: 3 mounths

    Body composition evaluated through weight mesured in kg, BMI (kg/m²), Fat mass index and fat mass measured through DEXA scan.

  15. Identification of factors associated with improvement in VO2max

    Time frame: 3 months

    We will use univariate and mutlivariate logistic regression analyses to assess the relationship between improvements in VO2max and a set of covariates individually or in combination.

Study contacts

Contact information is provided by the study sponsor or research team.

Stephanie Ziant

CONTACT

[email protected]

+3243668568

Sponsors and collaborators

Lead sponsor

University of Liege

Other

Registry information

Important dates

Study start
2020
Primary completion
2028
Study completion
2028
First posted
May 20, 2020
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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