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NCT Number: NCT04935125

The Effects of Endurance and Strength Training in Subjects With Asthma

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istituti Clinici Maugeri Pneumologia

Tradate, Lombardy, 21049, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard Program + Endurance and Strength training

Procedure

Sessions of strength training added to a standard inpatient multidisciplinary programme

Standard Program

Procedure

Standard inpatient multidisciplinary programme (including endurance training)

Primary outcomes

  1. asthma related Quality of Life

    Time frame: 4 weeks from enrollment

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

  2. asthma related Quality of Life

    Time frame: 1 year

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

Secondary outcomes

  1. Asthma control

    Time frame: 4 weeks from enrollment

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

  2. Eosinophilic airway inflammation

    Time frame: 4 weeks from enrollment

    Fractional Exhaled Nitric Oxide (FeNO),

  3. Aerobic capacity

    Time frame: 4 weeks from enrollment

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

  4. Quadriceps and biceps strength

    Time frame: 4 weeks from enrollment

    Maximal Voluntary isometric Strength (MVS).

  5. Quadriceps and biceps strength

    Time frame: 1 year

    Maximal Voluntary isometric Strength (MVS).

  6. Treatment satisfaction

    Time frame: 1 year

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

  7. Numbers of exacerbations

    Time frame: 1 year

    number of exacerbations in the last 12 months.

  8. Asthma control

    Time frame: 1 year

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

  9. Eosinophilic airway inflammation

    Time frame: 1 year

    Fractional Exhaled Nitric Oxide (FeNO).

  10. Aerobic capacity

    Time frame: 1 year

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

Sponsors and collaborators

Lead sponsor

Istituti Clinici Scientifici Maugeri SpA

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jun 22, 2021
Registry last updated
Mar 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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