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CompletedNCT04935125Updated Mar 5, 2024

The Effects of Endurance and Strength Training in Subjects With Asthma

An interventional study of Standard Program + Endurance and Strength training and Standard Program in Asthma, sponsored by Istituti Clinici Scientifici Maugeri SpA. Completed at 1 site in Italy. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-03-05.

Sponsored by Istituti Clinici Scientifici Maugeri SpA · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
58
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Asthma

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Keywords

  • Asthma
  • Resistance Training
  • Endurance Training
  • Quality of Life
03

In context

Asthma

3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.

This study's enrollment of 58 is below the median of 83 across 2,752 interventional studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

Istituti Clinici Scientifici Maugeri SpA is the lead sponsor of 113 studies on the registry; 46 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
58 participants (actual)

Study arms

  • Active comparator
    Standard Program

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

    Procedure: Standard Program + Endurance and Strength training · Procedure: Standard Program

  • Experimental
    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

    Procedure: Standard Program + Endurance and Strength training

Interventions

  • ProcedureStandard Program + Endurance and Strength training

    Sessions of strength training added to a standard inpatient multidisciplinary programme

  • ProcedureStandard Program

    Standard inpatient multidisciplinary programme (including endurance training)

06

What researchers measure

Primary outcomes

  1. asthma related Quality of Life

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

    Time frame: 4 weeks from enrollment

  2. asthma related Quality of Life

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

    Time frame: 1 year

Secondary outcomes

  1. Asthma control

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

    Time frame: 4 weeks from enrollment

  2. Eosinophilic airway inflammation

    Fractional Exhaled Nitric Oxide (FeNO),

    Time frame: 4 weeks from enrollment

  3. Aerobic capacity

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

    Time frame: 4 weeks from enrollment

  4. Quadriceps and biceps strength

    Maximal Voluntary isometric Strength (MVS).

    Time frame: 4 weeks from enrollment

  5. Quadriceps and biceps strength

    Maximal Voluntary isometric Strength (MVS).

    Time frame: 1 year

  6. Treatment satisfaction

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

    Time frame: 1 year

  7. Numbers of exacerbations

    number of exacerbations in the last 12 months.

    Time frame: 1 year

  8. Asthma control

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

    Time frame: 1 year

  9. Eosinophilic airway inflammation

    Fractional Exhaled Nitric Oxide (FeNO).

    Time frame: 1 year

  10. Aerobic capacity

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

    Time frame: 1 year

07

Study locations

1 site
  • Istituti Clinici Maugeri Pneumologia
    Tradate, Lombardia 21049, Italy
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 5, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04935125
Lead sponsor
Istituti Clinici Scientifici Maugeri SpA
Responsible party
Sponsor
First posted
Jun 22, 2021
Start date
Apr 13, 2021
Primary completion
Feb 23, 2024
Completion
Feb 23, 2024
Last update
Mar 5, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

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