Clinical trial NCT04935125: The Effects of Endurance and Strength Training in Subjects With Asthma
Official title: The Effects of Combined Endurance and Strength Training on Quality of Life in Subjects With Moderate-severe Asthma: a Randomized Controlled Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: Asthma
Resistance Training
Endurance Training
Quality of Life
Lead sponsor: Istituti Clinici Scientifici Maugeri SpA
Sponsor class: OTHER
First posted: 2021-06-22
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: asthma related Quality of Life
timeFrame: 4 weeks from enrollment
measure: asthma related Quality of Life
timeFrame: 1 year
Secondary outcomes:
measure: Asthma control
timeFrame: 4 weeks from enrollment
measure: Eosinophilic airway inflammation
timeFrame: 4 weeks from enrollment
measure: Aerobic capacity
timeFrame: 4 weeks from enrollment
measure: Quadriceps and biceps strength
timeFrame: 4 weeks from enrollment
measure: Quadriceps and biceps strength
timeFrame: 1 year
measure: Treatment satisfaction
timeFrame: 1 year
measure: Numbers of exacerbations
timeFrame: 1 year
measure: Asthma control
timeFrame: 1 year
measure: Eosinophilic airway inflammation
timeFrame: 1 year
measure: Aerobic capacity
timeFrame: 1 year
Other outcomes:
Locations:
city: Tradate
country: Italy
facility: Istituti Clinici Maugeri Pneumologia
state: Lombardia
Study officials:
References: