AsthmaNCT04935125
The Effects of Endurance and Strength Training in Subjects With Asthma
A study testing Standard Program + Endurance and Strength training and Standard Program in people with Asthma, run by Istituti Clinici Scientifici Maugeri SpA at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Asthma
- What is being tested?
- Standard Program + Endurance and Strength training and Standard Program
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteItaly
- Study dates
- 13 Apr 2021to 23 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Conditions
- Asthma
- Being tested
- Standard Program + Endurance and Strength training, Standard Program
- Keywords
- Asthma, Resistance Training, Endurance Training, Quality of Life
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Program + Endurance and Strength trainingProcedure or surgery
Sessions of strength training added to a standard inpatient multidisciplinary programme
Standard ProgramProcedure or surgery
Standard inpatient multidisciplinary programme (including endurance training)
| Study group | Role | What they receive |
|---|---|---|
| Standard Program | Active comparator | twelve 30-minute daily sessions of supervised incremental exercise training over a period of 3 weeks. Receives: Procedure: Standard Program + Endurance and Strength training; Procedure: 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 Receives: Procedure: Standard Program + Endurance and Strength training |
What is being measured
The primary outcome is the main question the study is designed to answer.
asthma related Quality of Life
Asthma Quality of Life Questionnaire (AQLQ). Range 0 (worst) - 7 (best)
Measured: 4 weeks from enrollment
asthma related Quality of Life
Asthma Quality of Life Questionnaire (AQLQ). Range 0 (worst) - 7 (best)
Measured: 1 year
Secondary outcomes (10)
Asthma control
Asthma Control Questionnaire (ACQ-6). Range 0 (best) - 6 (worst)
Measured: 4 weeks from enrollment
Eosinophilic airway inflammation
Fractional Exhaled Nitric Oxide (FeNO),
Measured: 4 weeks from enrollment
Aerobic capacity
Maximum oxygen capacity (VO2max) assessed by Cardio Pulmonary Exercise Test, (CPET).
Measured: 4 weeks from enrollment
Quadriceps and biceps strength
Maximal Voluntary isometric Strength (MVS).
Measured: 4 weeks from enrollment
Quadriceps and biceps strength
Maximal Voluntary isometric Strength (MVS).
Measured: 1 year
Treatment satisfaction
Global Perceived Effect (GPE) score 1 (best) - 7 (worst)
Measured: 1 year
Numbers of exacerbations
number of exacerbations in the last 12 months.
Measured: 1 year
Asthma control
Asthma Control Questionnaire (ACQ-6) Range 0 (best) - 6 (worst)
Measured: 1 year
Eosinophilic airway inflammation
Fractional Exhaled Nitric Oxide (FeNO).
Measured: 1 year
Aerobic capacity
Maximum oxygen capacity(VO2max) assessed by Cardio Pulmonary Exercise Test (CPET)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2021
- Study start13 Apr 2021
- Primary completion23 Feb 2024
- Study completion23 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Istituti Clinici Scientifici Maugeri SpAThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04935125
- Sponsor's protocol ID
- 2525CE
- Status last verified
- Feb 2024
- First submitted
- 5 May 2021
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 41370562
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Combined Endurance and Strength Training on Quality of Life in Subjects With Moderate-severe Asthma: a Randomized Controlled Study.
- ClinicalTrials.gov ID
- NCT04935125
- Acronym / sponsor ID
- 2525CE
- Conditions
- Asthma
- Keywords
- Asthma, Resistance Training, Endurance Training, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpAUniversity, hospital or other
- Study start
- 13 Apr 2021 (actual)
- Primary completion
- 23 Feb 2024 (actual)
- Study completion
- 23 Feb 2024 (actual)
- First posted
- 22 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Program | Active comparator | Procedure: Standard Program + Endurance and Strength training, Procedure: Standard Programtwelve 30-minute daily sessions of supervised incremental exercise training over a period of 3 weeks. |
| Strength training | Experimental | Procedure: Standard 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Program + Endurance and Strength trainingSessions of strength training added to a standard inpatient multidisciplinary programme | Procedure or surgery | Standard Program, Strength training |
| Standard ProgramStandard inpatient multidisciplinary programme (including endurance training) | Procedure or surgery | Standard Program |
Primary outcome
asthma related Quality of Life
Time frame: 4 weeks from enrollment
Asthma Quality of Life Questionnaire (AQLQ). Range 0 (worst) - 7 (best)
asthma related Quality of Life
Time frame: 1 year
Asthma Quality of Life Questionnaire (AQLQ). Range 0 (worst) - 7 (best)
10 secondary outcomes
Asthma control
Time frame: 4 weeks from enrollment
Eosinophilic airway inflammation
Time frame: 4 weeks from enrollment
Aerobic capacity
Time frame: 4 weeks from enrollment
Quadriceps and biceps strength
Time frame: 4 weeks from enrollment
Quadriceps and biceps strength
Time frame: 1 year
Treatment satisfaction
Time frame: 1 year
Numbers of exacerbations
Time frame: 1 year
Asthma control
Time frame: 1 year
Eosinophilic airway inflammation
Time frame: 1 year
Aerobic capacity
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
- Derived from this study: PubMed 41370562Bello 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Program + Endurance and Strength training and Standard Program in people with Asthma, run by Istituti Clinici Scientifici Maugeri SpA at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
asthma related Quality of Life (time frame: 4 weeks from enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04935125, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2024.