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The Effects of Endurance and Strength Training in Subjects With Asthma

Not Applicable
Completed
Conditions
Asthma
Interventions
Procedure: Standard Program + Endurance and Strength training
Procedure: Standard Program
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.

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
Arm && Interventions
GroupInterventionDescription
Standard ProgramStandard Program + Endurance and Strength trainingtwelve 30-minute daily sessions of supervised incremental exercise training over a period of 3 weeks.
Standard ProgramStandard Programtwelve 30-minute daily sessions of supervised incremental exercise training over a period of 3 weeks.
Strength trainingStandard Program + Endurance and Strength trainingtwelve 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
Primary Outcome Measures
NameTimeMethod
asthma related Quality of Life1 year

Asthma Quality of Life Questionnaire (AQLQ). Range 0 (worst) - 7 (best)

Secondary Outcome Measures
NameTimeMethod
Asthma control1 year

Asthma Control Questionnaire (ACQ-6) Range 0 (best) - 6 (worst)

Aerobic capacity1 year

Maximum oxygen capacity(VO2max) assessed by Cardio Pulmonary Exercise Test (CPET)

Eosinophilic airway inflammation1 year

Fractional Exhaled Nitric Oxide (FeNO).

Quadriceps and biceps strength1 year

Maximal Voluntary isometric Strength (MVS).

Treatment satisfaction1 year

Global Perceived Effect (GPE) score 1 (best) - 7 (worst)

Numbers of exacerbations1 year

number of exacerbations in the last 12 months.

Trial Locations

Locations (1)

Istituti Clinici Maugeri Pneumologia

🇮🇹

Tradate, Lombardia, Italy

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