The Effects of Endurance and Strength Training in Subjects With Asthma

NCT ID: NCT04935125

Last Updated: 2024-03-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-13
• Study Completion Date: 2024-02-23

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.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Standard Program

twelve 30-minute daily sessions of supervised incremental exercise training over a period of 3 weeks.

Group Type: ACTIVE_COMPARATOR

Standard Program + Endurance and Strength training

Intervention Type: PROCEDURE

Sessions of strength training added to a standard inpatient multidisciplinary programme

Standard Program

Intervention Type: PROCEDURE

Standard inpatient multidisciplinary programme (including endurance training)

Strength training

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

Group Type: EXPERIMENTAL

Standard Program + Endurance and Strength training

Intervention Type: PROCEDURE

Sessions of strength training added to a standard inpatient multidisciplinary programme

Interventions

Standard Program + Endurance and Strength training

Sessions of strength training added to a standard inpatient multidisciplinary programme

Intervention Type: PROCEDURE

Standard Program

Standard inpatient multidisciplinary programme (including endurance training)

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istituti Clinici Scientifici Maugeri SpA

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Istituti Clinici Maugeri Pneumologia

Tradate, Lombardy, Italy

Countries

Italy

Other Identifiers

2525CE

Identifier Type: -

Identifier Source: org_study_id