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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Asthma
• Intervention / Treatment: Other: Respiratory physiotherapy; Other: Aerobic exercise training

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stephanie Ziant; Phone Number: +3243668568; Email: sziant@chuliege.be

Study Locations

• Belgium
  • Liege
    • Liège, Liege, Belgium, 4000
      • Recruiting
      • Chu Liege
      • Contact: stephanie ziant; Phone Number: +3243668568
      • Sub-Investigator: Florence Schleich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: respiratory physiotherapy; 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.	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.
No Intervention: control group; No intervention - collection of data at baseline and 3 months without any intervention in between.
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: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vo2max (maximum oxygen consumption)	change from baseline Vo2Max at 3 months	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	3 months
Asthma Control Questionnaire (ACQ)	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	3 months
FEV1 (Forced Expiratory volume in 1 second)	Change from Baseline FEV1 at 3 months	3 months
Amount of eosinophils and neutrophils in sputum	Change from baseline in amount of eosinophils and neutrophils in sputum	3 months
FeNo (fractional exhaled nitric oxide)	change from baseline FENO at 3 months	3 months
PMA (Maximum aerobic power)	change from baseline PMA at 3 months	3 months
sputum cell counts	change from baseline	3 months
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	3 months
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	3 months
FVC (Forced Vital Capacity)	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	3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
fall in FEV1 during ergospirometric measurement	Change from Baseline fall in FEV1 during ergospirometric measurement	3 months
PC20M (measures the concentration of metacholine necessary to bring down the FEV1 by 20% compared to its base value)	Change from baseline PC20M at 3 months	3 months
TLC (Total Lung Capacity)	It is the total volume of air in the lungs after a maximal inspiration change from baseline TLC at 3 months	3 months
DLCO (Diffusing Capacity of the Lung for Carbon Monoxide)	Measures the efficiency of the gas transfer characteristics of the lungs change from baseline DLCO at 3 months	3 months
KCO (transfer coefficient of the lung for carbon monoxide)	change from baseline KCO at 3 months	3 months
FRC (Functional Residual Capacity)	The volume of air present in the lungs at the end of passive expiration Change from baseline FRC at 3 months	3 months
RV (Residual Volume)	It is the amount of air remaining in the lungs after a maximal expiration Change from baseline RV at 3 months	3 months
sGaw (Specific airway conductance)	Change from baseline sGaw at 3 months	3 months
maximal inspiratory power	Measured in KPa Change from baseline	3 months
maximal expiratory power	Measured in KPa Change from baseline	3 months
isometric force of long finger grasp	measured using a Jamar dynamometer change from baseline	3 months
maximum isometric force of the quadriceps	measured using a dynamometer Change from baseline	3 months
VOCs	volatils organics compounds change from baseline	3 months
Body composition	Body composition evaluated through weight mesured in kg, BMI (kg/m²), Fat mass index and fat mass measured through DEXA scan.	3 mounths
Identification of factors associated with improvement in VO2max	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.	3 months

Collaborators and Investigators

• Sponsor: University of Liege

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028

Study Registration Dates

• First Submitted: May 4, 2020
• First Submitted That Met QC Criteria: May 14, 2020
• First Posted (Actual): May 20, 2020

Study Record Updates

• Last Update Posted (Actual): April 14, 2026
• Last Update Submitted That Met QC Criteria: April 13, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: B707202042981

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No