The Effects of Endurance and Strength Training in Subjects With Asthma

Study Overview
=================
Brief Summary
-----------------
Emerging evidence suggests that regular exercise can complement medical treatment for asthma. Furthermore there are no specific recommendation on how plan exercise training. To the best of current knowledge, there isn't enough evidence of the effect of a strength training in subjects with asthma. Therefore the aim of this study is to evaluate the short and long term effects of a strength and endurance training compared with endurance training alone in subjects with asthma.

Detailed Description
-----------------
To the best of current knowledge, there isn't enough evidence of the effect of a strength training in subjects with asthma. Aim of the study is evaluate the short (after pulmonary rehabilitation) and long term (after 12 months) effects of a strength and endurance training compared with endurance training alone in improving quality of life and disease control in subjects with asthma of Global Initiative for Asthma (GINA) stage from 4 to 5.This is a prospective randomized control trial. Subjects with diagnosis of asthma according to the GINA guidelines admitted to a reference centre for inpatient pulmonary rehabilitation will be randomly assigned to study or control group.

Official Title
-----------------
The Effects of Combined Endurance and Strength Training on Quality of Life in Subjects With Moderate-severe Asthma: a Randomized Controlled Study.

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Procedure: Standard Program + Endurance and Strength training
* Procedure: Standard Program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of asthma step 4 to 5 under optimal medical treatment for at least 6 months according to GINA guideline Symptomatic despite being on treatment: Asthma Control Test (ACT) score ≥ 20 ≤24 Able to perform and complete with studies procedures (FeNO, CPET, Six Minute Walking Test (6MWT), MVS. Exclusion Criteria: Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) according to the Global initiative for Obstructive Lung Disease (GOLD) guidelines criteria Smokers or ex-smokers with pack/years ≥10 Body Mass Index (BMI) ≥30 Change in asthma medications in the last 30 days Cognitive impairment (Mini-Mental State Examination score <22) History of oncological, neurological, cardiovascular diseases, musculoskeletal impairment and/or medical diseases precluding exercise testing and pulmonary rehabilitation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Program<br>twelve 30-minute daily sessions of supervised incremental exercise training over a period of 3 weeks. | Procedure: Standard Program + Endurance and Strength training<br>* Sessions of strength training added to a standard inpatient multidisciplinary programme<br>Procedure: Standard Program<br>* Standard inpatient multidisciplinary programme (including endurance training)<br>|
| Experimental: Strength training<br>twelve 30-minute daily sessions of supervised incremental exercise training over a period of 3 weeks twelve 30-minute daily sessions of supervised peripheral limb muscle training, 2 set of 6-12 repetitions | Procedure: Standard Program + Endurance and Strength training<br>* Sessions of strength training added to a standard inpatient multidisciplinary programme<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| asthma related Quality of Life | Asthma Quality of Life Questionnaire (AQLQ). Range 0 (worst) - 7 (best) | 4 weeks from enrollment | 
| asthma related Quality of Life | Asthma Quality of Life Questionnaire (AQLQ). Range 0 (worst) - 7 (best) | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asthma control | Asthma Control Questionnaire (ACQ-6). Range 0 (best) - 6 (worst) | 4 weeks from enrollment | 
| Eosinophilic airway inflammation | Fractional Exhaled Nitric Oxide (FeNO), | 4 weeks from enrollment | 
| Aerobic capacity | Maximum oxygen capacity (VO2max) assessed by Cardio Pulmonary Exercise Test, (CPET). | 4 weeks from enrollment | 
| Quadriceps and biceps strength | Maximal Voluntary isometric Strength (MVS). | 4 weeks from enrollment | 
| Quadriceps and biceps strength | Maximal Voluntary isometric Strength (MVS). | 1 year | 
| Treatment satisfaction | Global Perceived Effect (GPE) score 1 (best) - 7 (worst) | 1 year | 
| Numbers of exacerbations | number of exacerbations in the last 12 months. | 1 year | 
| Asthma control | Asthma Control Questionnaire (ACQ-6) Range 0 (best) - 6 (worst) | 1 year | 
| Eosinophilic airway inflammation | Fractional Exhaled Nitric Oxide (FeNO). | 1 year | 
| Aerobic capacity | Maximum oxygen capacity(VO2max) assessed by Cardio Pulmonary Exercise Test (CPET) | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Asthma, Resistance Training, Endurance Training, Quality of Life