AsthmaNCT05486689
Evaluation of Physical Activity in Asthmatic Subjects
A study testing Pulmonary Rehabilitation in people with Asthma and Physical Activity, run by Istituti Clinici Scientifici Maugeri SpA at 1 site in Italy.
Trial summary
Asthma is a chronic disease, which leads to a number of adverse outcomes, including lower levels of physical activity (PA). Physical inactivity is an important risk factor, increasing PA has become a patient-centred goal for the treatment of subjects with asthma. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Asthma, Physical Activity
- What is being tested?
- Pulmonary Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteItaly
- Study dates
- 30 Jun 2022to 5 Dec 2023
- 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 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of asthma according to GINA step 3-5
- body mass index (BMI) between 18.5 and 24.9 kg/m2
- under optimal medical treatment for at least 3 months according to GINA guideline
- able to perform and complete with studies procedures.
Who cannot join
- diagnosis of any other chronic pulmonary disease
- smokers or ex-smokers with pack/years ≥10
- acute exacerbation of asthma in the last 30 days
- engagement in exercise training program in the previous 6 months
- history of significant oncological, neurological, cardiovascular diseases
- musculoskeletal impairment
Show all 9Show fewer
- medical diseases that are likely to compromise mobility and precluding exercise testing and PR
- use of a walker when moving
- reduced spontaneous gait speed (10 m walk test< at 0.8 m/sec).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Physical Activity Before and After Respiratory Rehabilitation in Normal Weight
Asthma is a chronic disease, which leads to a number of adverse outcomes, including lower levels of physical activity (PA). Physical inactivity is an important risk factor, increasing PA has become a patient-centred goal for the treatment of subjects with asthma. Data provided by activity monitors are commonly used to measure daily PA.
A recent systematic review showed that adults with asthma had lower levels of total, moderate and vigorous physical activity than those without asthma. There are no data showing the possible effects of a Pulmonary Rehabilitation (PR) program on PA (number of daily steps) in normal-weight subjects with asthma. The main objective of this pilot study is to obtain estimates of the mean value of number of daily steps, time spent on activity in hours and of other variables in normal-weight subjects with asthma measured before and after the PR program. No estimates about these parameters in the same population are currently available from literature search.
Read the detailed description
Asthma is a chronic disease, which leads to a number of adverse outcomes, including possible lower levels of physical activity (PA). Physical inactivity is an important risk factor, it and was shown that training improves cardiopulmonary fitness, symptoms and quality of life. Increasing PA has become a patient-centred goal for the treatment of subjects with asthma.
Data provided by activity monitors are commonly used to measure daily PA. For PA assessments using an accelerometer, recordings of at least 4 weekly days with a minimum of 8 hours of monitor use (during waking hours) are recommended. A recent systematic review showed that adults with asthma had lower levels of total, moderate and vigorous physical activity than those without asthma. Physical activity appears to be influenced by comorbidities such as obesity in addition to age and sex, decreased disease control, and increased severity. Ather authors involved obese subjects with asthma assigned to a 12-month lifestyle intervention dually targeted modest weight loss (achieve and maintain a weight loss of 7% of baseline body weight) and increased physical activity (achieve and maintain a minimum of 150 minutes per week of moderate intensity physical activity) compared with usual care (control group). Moderately and severely obese adults with uncontrolled asthma showed modest average weight reduction and PA improvements. Finally was showed that a comprehensive pulmonary rehabilitation (PR) program including a weight loss program and exercise training improves PA in moderately-severely obese adults with asthma.
There are no data showing the possible effects of a PR program on PA (number of daily steps) in normal-weight subjects with asthma.
The main objective of this pilot study is to obtain estimates of the mean value (and standard deviation) of number of daily steps, time spent on activity in hours and of other variables in normal-weight subjects with asthma measured before and after the PR program. No estimates about these parameters in the same population are currently available from literature search. This information will be used for formal sample size calculations when planning a future larger study investigating the number of daily steps and time in activity of normal-weight subjects with asthma before and after PR.
- Conditions
- Asthma, Physical Activity
- Being tested
- Pulmonary Rehabilitation
- Medical subject headings
- Asthma, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary RehabilitationOther
The enrolled subjects will receivePR program. The 3 weeks inpatient PR will include education, exercise training, nutritional and psychological counselling.
Education: individualized session of 20 minutes each and group session of 45 minutes each. Endurance training: at least twelve 30-minute daily sessions of supervised incremental exercise training according to Maltais, continuous cycling at 50-70% of the maximal load calculated on the basis of the baseline 6MWT according to Hill. Strength training: twelve 30-minute daily sessions of peripheral limb muscle strength training: 2 set of 8 repetitions during the first week, increased at 12 from the second. The initial load will be set at 30/50% of maximal voluntary isometric strength (MVS). Psychological intervention: individual tailored intervention will be offered when the Hospital Anxiety and Depression Scale (HADS) score is >10 or judged necessary by clinicians, after verifying the subject's motivation.
| Study group | Role | What they receive |
|---|---|---|
| Standard Program | Experimental | Pulmonary Rehabilitation Receives: Other: Pulmonary Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity
number of daily steps
Measured: 5 days after pulmonary rehabilitation
Daily activity
hours spent in activity in a day
Measured: 5 days after pulmonary rehabilitation
Secondary outcomes (6)
health-related quality of life
Asthma Quality of Life Questionnaire (AQLQ), 0-7 (higher score indicating better quality of life)
Measured: 1 day after pulmonary rehabilitation
Asthma control
Asthma Control Test (ACT), 5-25 (higher score indicating better asthma control)
Measured: 1 day after pulmonary rehabilitation
Exercise capacity
Six minute walking test (6MWT)
Measured: 1 day after pulmonary rehabilitation
Quadriceps strength
maximal voluntary strength (MVS)
Measured: 1 day after pulmonary rehabilitation
Biceps strength
maximal voluntary strength (MVS)
Measured: 1 day after pulmonary rehabilitation
Mood
Hospital Anxiety and depression scale (HADS), 0-21 0-50 (higher score indicating worst mood)
Measured: 1 day after pulmonary rehabilitation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2022
- Study start30 Jun 2022
- Primary completion1 Dec 2023
- Study completion5 Dec 2023
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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpA
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, RicercaTradate, Istituti Clinici Scientifici Maugeri SpA
- Investigators
- Dina Visca, Prof, Study chair, ICS Maugeri
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05486689
- Sponsor's protocol ID
- 2652
- Status last verified
- Dec 2023
- First submitted
- 14 Jul 2022
- Last updated
- 6 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Oliva FM, Tarasconi M, Malovini A, Zappa M, Visca D, Zampogna E. Evaluation of physical activity before and after respiratory rehabilitation in normal weight individuals with asthma: a feasibility study. Front Sports Act Living. 2024 May 9;6:1372048. doi: 10.3389/fspor.2024.1372048. eCollection 2024.
PubMed 38783863
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Physical Activity Before and After Respiratory Rehabilitation in Normal Weight
- ClinicalTrials.gov ID
- NCT05486689
- Acronym / sponsor ID
- 2652
- Conditions
- Asthma, Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpAUniversity, hospital or other
- Study start
- 30 Jun 2022 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 5 Dec 2023 (actual)
- First posted
- 3 Aug 2022 (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.
Asthma is a chronic disease, which leads to a number of adverse outcomes, including lower levels of physical activity (PA). Physical inactivity is an important risk factor, increasing PA has become a patient-centred goal for the treatment of subjects with asthma. Data provided by activity monitors are commonly used to measure daily PA.
A recent systematic review showed that adults with asthma had lower levels of total, moderate and vigorous physical activity than those without asthma. There are no data showing the possible effects of a Pulmonary Rehabilitation (PR) program on PA (number of daily steps) in normal-weight subjects with asthma. The main objective of this pilot study is to obtain estimates of the mean value of number of daily steps, time spent on activity in hours and of other variables in normal-weight subjects with asthma measured before and after the PR program. No estimates about these parameters in the same population are currently available from literature search.
Detailed description
Asthma is a chronic disease, which leads to a number of adverse outcomes, including possible lower levels of physical activity (PA). Physical inactivity is an important risk factor, it and was shown that training improves cardiopulmonary fitness, symptoms and quality of life. Increasing PA has become a patient-centred goal for the treatment of subjects with asthma.
Data provided by activity monitors are commonly used to measure daily PA. For PA assessments using an accelerometer, recordings of at least 4 weekly days with a minimum of 8 hours of monitor use (during waking hours) are recommended. A recent systematic review showed that adults with asthma had lower levels of total, moderate and vigorous physical activity than those without asthma. Physical activity appears to be influenced by comorbidities such as obesity in addition to age and sex, decreased disease control, and increased severity. Ather authors involved obese subjects with asthma assigned to a 12-month lifestyle intervention dually targeted modest weight loss (achieve and maintain a weight loss of 7% of baseline body weight) and increased physical activity (achieve and maintain a minimum of 150 minutes per week of moderate intensity physical activity) compared with usual care (control group). Moderately and severely obese adults with uncontrolled asthma showed modest average weight reduction and PA improvements. Finally was showed that a comprehensive pulmonary rehabilitation (PR) program including a weight loss program and exercise training improves PA in moderately-severely obese adults with asthma.
There are no data showing the possible effects of a PR program on PA (number of daily steps) in normal-weight subjects with asthma.
The main objective of this pilot study is to obtain estimates of the mean value (and standard deviation) of number of daily steps, time spent on activity in hours and of other variables in normal-weight subjects with asthma measured before and after the PR program. No estimates about these parameters in the same population are currently available from literature search. This information will be used for formal sample size calculations when planning a future larger study investigating the number of daily steps and time in activity of normal-weight subjects with asthma before and after PR.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective
| Arm | Type | Receives |
|---|---|---|
| Standard Program | Experimental | Other: Pulmonary RehabilitationPulmonary Rehabilitation |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- diagnosis of asthma according to GINA step 3-5
- body mass index (BMI) between 18.5 and 24.9 kg/m2
- under optimal medical treatment for at least 3 months according to GINA guideline
- able to perform and complete with studies procedures.
Key exclusion criteria (9 listed)
- diagnosis of any other chronic pulmonary disease
- smokers or ex-smokers with pack/years ≥10
- acute exacerbation of asthma in the last 30 days
- engagement in exercise training program in the previous 6 months
- history of significant oncological, neurological, cardiovascular diseases
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 |
|---|---|---|
| Pulmonary RehabilitationThe enrolled subjects will receivePR program. The 3 weeks inpatient PR will include education, exercise training, nutritional and psychological counselling. Education: individualized session of 20 minutes each and group session of 45 minutes each. Endurance training: at least twelve 30-minute daily sessions of supervised incremental exercise training according to Maltais, continuous cycling at 50-70% of the maximal load calculated on the basis of the baseline 6MWT according to Hill. Strength training: twelve 30-minute daily sessions of peripheral limb muscle strength training: 2 set of 8 repetitions during the first week, increased at 12 from the second. The initial load will be set at 30/50% of maximal voluntary isometric strength (MVS). Psychological intervention: individual tailored intervention will be offered when the Hospital Anxiety and Depression Scale (HADS) score is >10 or judged necessary by clinicians, after verifying the subject's motivation. | Other | Standard Program |
Primary outcome
Physical activity
Time frame: 5 days after pulmonary rehabilitation
number of daily steps
Daily activity
Time frame: 5 days after pulmonary rehabilitation
hours spent in activity in a day
6 secondary outcomes
health-related quality of life
Time frame: 1 day after pulmonary rehabilitation
Asthma control
Time frame: 1 day after pulmonary rehabilitation
Exercise capacity
Time frame: 1 day after pulmonary rehabilitation
Quadriceps strength
Time frame: 1 day after pulmonary rehabilitation
Biceps strength
Time frame: 1 day after pulmonary rehabilitation
Mood
Time frame: 1 day after pulmonary rehabilitation
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 6 Dec 2023.
- Derived from this study: PubMed 38783863Oliva FM, Tarasconi M, Malovini A, Zappa M, Visca D, Zampogna E. Evaluation of physical activity before and after respiratory rehabilitation in normal weight individuals with asthma: a feasibility study. Front Sports Act Living. 2024 May 9;6:1372048. doi: 10.3389/fspor.2024.1372048. eCollection 2024.
- Individual participant dataSharing planned: No
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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.
Dina Visca, Prof study chair
ICS Maugeri
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulmonary Rehabilitation in people with Asthma and Physical Activity, 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 4 inclusion and 9 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 6 Dec 2023. 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?
Physical activity (time frame: 5 days after pulmonary rehabilitation). 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 NCT05486689, 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 6 Dec 2023.