The Effects of Endurance and Strength Training in Subjects With Asthma

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04935125
• Other study ID #: 2525CE
• Status: Completed
• Phase: N/A
• Start date: April 13, 2021
• Est. completion date: February 23, 2024

Study information

• Verified date: February 2024
• Source: Istituti Clinici Scientifici Maugeri SpA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: February 23, 2024
• Est. primary completion date: February 23, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

Procedure:
• Standard Program + Endurance and Strength training
Sessions of strength training added to a standard inpatient multidisciplinary programme
• Standard Program
Standard inpatient multidisciplinary programme (including endurance training)

Locations

Country	Name	City	State
Italy	Istituti Clinici Maugeri Pneumologia	Tradate	Lombardia

Sponsors (1)

Lead Sponsor	Collaborator
Istituti Clinici Scientifici Maugeri SpA

Country where clinical trial is conducted

Italy, 

Outcome

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