Effects of Regular Submaximal Exercise on Asthma Control and Quality of Life in Patients With Persistent Symptoms

Study Overview
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Brief Summary
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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 physical exercise on quality of life, on symptomatic control, and on bronchial and systemic inflammatory markers in patients with persistant asthma.

Detailed Description
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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 quality of life, asthma control, bronchial hyperresponsiveness and bronchial and systemic inflammation in patients with persistent asthma The hypothesis is that regular physical exercise increases control and quality of life and reduces inflammation and bronchial hyperresponsiveness compared to simple physiotherapy sessions.

Official Title
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Effects of Submaximal Regular Physical Exercise on Quality of Life, Symptomatic Control, and Bronchial and Systemic Inflammatory Markers in Patients With Persistent Asthma

Conditions
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Chronic Asthma

Intervention / Treatment
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* Other: exercises


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: asthmatic patient aged 18- 90 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: respiratory physiotherapy<br>exercises to improve the way of breathing | Other: exercises<br>* One hour twice a week to practice respiratory exercises, postural exercises, muscular exercises<br>|
| Experimental: respiratory physiotherapy and physical exercises<br>intensity determined by the VO2max measured during ergospirometric measure | Other: exercises<br>* One hour twice a week to practice respiratory exercises, postural exercises, muscular exercises<br>|
| No Intervention: control group<br> | |

What is the study measuring?
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Primary 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 | 
| fall in FEV1 during ergospirometric measurement | Change from Baseline fall in FEV1 during ergospirometric measurement | 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 | 
| 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 | 
| Vo2max (maximum oxygen consumption) | change from baseline Vo2Max 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 | 
| 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 form baseline | 3 months |