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

NCT04395937 | Recruiting DMC

• 1 other identifier: B707202042981
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Asthma

Outcome Measures

Primary Outcomes (1)

• Vo2max (maximum oxygen consumption)

  change from baseline Vo2Max at 3 months

  3 months

Secondary Outcomes (10)

• Asthma Quality of Life Questionnaire (AQLQ)

  3 months

• FEV1 (Forced Expiratory volume in 1 second)

  3 months

• Asthma control test (ACT)

  3 months

• Hospital Anxiety and depression scale (HAD)

  3 months

• sputum cell counts

  3 months

Other Outcomes (15)

• maximal inspiratory power

  3 months

• maximal expiratory power

  3 months

• maximum isometric force of the quadriceps

  3 months

Study Arms (3)

respiratory physiotherapy

ACTIVE COMPARATOR

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

control group

NO INTERVENTION

No intervention - collection of data at baseline and 3 months without any intervention in between.

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.

Other: Aerobic exercise training

Interventions

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.

Aerobic exercise 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.

respiratory physiotherapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Liege: lead

Study Sites (1)

Chu Liege

Liège, Liege, 4000, Belgium

RECRUITING

Central Study Contacts

Stephanie Ziant

CONTACT

+3243668568; sziant@chuliege.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Doctor

Study Record Dates

• First Submitted: May 4, 2020
• First Posted: May 20, 2020
• Study Start: September 1, 2020
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: April 14, 2026

Record last verified: 2026-04

Locations

BE (1)