The Effects of Endurance and Strength Training in Subjects With Asthma

Not Applicable

Completed

• Conditions: Asthma

• Registration Number: NCT04935125
• Lead Sponsor: Istituti Clinici Scientifici Maugeri SpA

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.

Study Timeline

• Study Start: 2021-04-13
• Study First Submitted: 2021-05-05
• Study First Submitted QC: 2021-06-10
• Study First Posted: 2021-06-22
• Status Verified: 2024-02
• Primary Completion: 2024-02-23
• Study Completion: 2024-02-23
• Last Update Submitted: 2024-03-04
• Last Update Posted: 2024-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
asthma related Quality of Life	1 year	Asthma Quality of Life Questionnaire (AQLQ). Range 0 (worst) - 7 (best)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Istituti Clinici Maugeri Pneumologia; 🇮🇹 Tradate, Lombardia, Italy