The Effects of Endurance and Strength Training in Subjects With Asthma

March 4, 2024 updated by: Istituti Clinici Scientifici Maugeri SpA

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Lombardia
      • Tradate, Lombardia, Italy, 21049
        • Istituti Clinici Maugeri Pneumologia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Sessions of strength training added to a standard inpatient multidisciplinary programme
Procedure: Standard Program
Standard inpatient multidisciplinary programme (including endurance training)
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
Sessions of strength training added to a standard inpatient multidisciplinary programme

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
asthma related Quality of Life
Time Frame: 4 weeks from enrollment
Asthma Quality of Life Questionnaire (AQLQ). Range 0 (worst) - 7 (best)
4 weeks from enrollment
asthma related Quality of Life
Time Frame: 1 year
Asthma Quality of Life Questionnaire (AQLQ). Range 0 (worst) - 7 (best)
1 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituti Clinici Scientifici Maugeri SpA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 13, 2021

Primary Completion (Actual)

February 23, 2024

Study Completion (Actual)

February 23, 2024

Study Registration Dates

First Submitted

May 5, 2021

First Submitted That Met QC Criteria

June 10, 2021

First Posted (Actual)

June 22, 2021

Study Record Updates

Last Update Posted (Actual)

March 5, 2024

Last Update Submitted That Met QC Criteria

March 4, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2525CE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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