NCT04935125

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable asthma

Timeline
Completed

Started Apr 2021

Typical duration for not_applicable asthma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 13, 2021

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

May 5, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 22, 2021

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 23, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 23, 2024

Completed
Last Updated

March 5, 2024

Status Verified

February 1, 2024

Enrollment Period

2.9 years

First QC Date

May 5, 2021

Last Update Submit

March 4, 2024

Conditions

Asthma

Keywords

AsthmaResistance TrainingEndurance TrainingQuality of Life

Outcome Measures

Primary Outcomes (2)

  • asthma related Quality of Life

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

    4 weeks from enrollment

  • asthma related Quality of Life

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

    1 year

Secondary Outcomes (10)

  • Asthma control

    4 weeks from enrollment

  • Eosinophilic airway inflammation

    4 weeks from enrollment

  • Aerobic capacity

    4 weeks from enrollment

  • Quadriceps and biceps strength

    4 weeks from enrollment

  • Quadriceps and biceps strength

    1 year

  • +5 more secondary outcomes

Study Arms (2)

Standard Program

ACTIVE COMPARATOR

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

Procedure: Standard Program + Endurance and Strength trainingProcedure: Standard Program

Strength training

EXPERIMENTAL

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

Standard Program + Endurance and Strength trainingPROCEDURE

Sessions of strength training added to a standard inpatient multidisciplinary programme

Standard ProgramStrength training
Standard ProgramPROCEDURE

Standard inpatient multidisciplinary programme (including endurance training)

Standard Program

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituti Clinici Maugeri Pneumologia

Tradate, Lombardy, 21049, Italy

Location

Related Publications (1)

  • Bello GL, Oliva FM, Malovini A, Ambrosino N, Tarasconi M, Zanini A, Zampogna E. Effect of combined strength and endurance training in adults with asthma: a randomized controlled trial. J Bras Pneumol. 2025 Dec 5;51(5):e20250009. doi: 10.36416/1806-3756/e20250009. eCollection 2025.

    PMID: 41370562DERIVED

MeSH Terms

Conditions

Asthma

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2021

First Posted

June 22, 2021

Study Start

April 13, 2021

Primary Completion

February 23, 2024

Study Completion

February 23, 2024

Last Updated

March 5, 2024

Record last verified: 2024-02

Locations

IT(1)