Chronic Asthma
Conditions
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.
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
OTHERAerobic 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.
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.
Sponsors
University of Liege
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vo2max (maximum oxygen consumption) | 3 months | change from baseline Vo2Max at 3 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Asthma Quality of Life Questionnaire (AQLQ) | 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 |
| FEV1 (Forced Expiratory volume in 1 second) | 3 months | Change from Baseline FEV1 at 3 months |
| Asthma control test (ACT) | 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 |
| Hospital Anxiety and depression scale (HAD) | 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 |
| sputum cell counts | 3 months | change from baseline |
| FeNo (fractional exhaled nitric oxide) | 3 months | change from baseline FENO at 3 months |
| FVC (Forced Vital Capacity) | 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 |
| Amount of eosinophils and neutrophils in sputum | 3 months | Change from baseline in amount of eosinophils and neutrophils in sputum |
| Asthma Control Questionnaire (ACQ) | 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 |
| PMA (Maximum aerobic power) | 3 months | change from baseline PMA at 3 months |
Countries
Belgium
Contacts
CONTACTStephanie Ziant
Outcome results
None listed