OutcomeNCT03922789
Minimal Important Difference of Walking Test in Subjects With Bronchial Asthma
An observational study of Outcome and Asthma, run by Maugeri Foundation at 1 site in Italy.
Trial summary
The Six Minute Walking Test (6MWT) efficiently represents the exercise capacity in subjects with chronic respiratory disease, as asthma. The variation of the walking distance is a parameter used to evaluate the effectiveness of pharmacologic ando non-pharmacologic interventions, as Pulmonary Rehabilitation (PR). Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Outcome, Asthma, Pulmonary Rehabilitation
- What is being tested?
- 6 minute walking test
- How many people
- 36 participants
- Where
- 1 siteItaly
- Study dates
- 16 Apr 2019to 1 Aug 2020
- Phase
- Observational
- 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 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects hospitalized in a Rehabilitation Center to complete a pulmonary rehabilitation programme
Who may be able to join
- Documented diagnosis of asthma according to the current guidelines "Global Initiative for Asthma (GINA)
- In therapy with inhaled and/or oral drugs ≥30 days
- Signature of Informed Consent.
Who cannot join
- Concomitant pathologies with severe short term prognosis.
- Documented Chronic Obstructive Pulmonary Disease diagnosis.
- Inability to perform the 6 Minute Walking Test
Trial locations and contacts
1 site in 1 country.
About this study
The Six Minute Walking Test (6MWT) efficiently represents the exercise capacity in subjects with chronic respiratory disease, as asthma. The variation of the walking distance is a parameter used to evaluate the effectiveness of pharmacologic ando non-pharmacologic interventions, as Pulmonary Rehabilitation (PR). However, statistically significant changes in the walking distance do not always represent clinically significant variations.The aim of this prospective study is to determine the Minimal Important Difference (MID) for the 6MWT in subjects affected by asthma, regardless of the severity of the disease.
Read the detailed description
The Six Minute Walking Test (6MWT) efficiently represents the exercise capacity in subjects with chronic respiratory disease, as asthma. The variation of the walking distance is a parameter used to evaluate the effectiveness of pharmacologic and non-pharmacologic interventions, asPulmonary Rehabilitation (PR). However, statistically significant changes in the walking distance do not always represent clinically significant variations. For this reason, it is important to understand in terms of clinical impact, how to interpret the 6MWT when the walking distance changes over time in the same subject (for example, at the beginning and after PR) or when it differs between subjects (some subjects may improve more and some subjects less). It is not enough to state that the intervention works, it is necessary to say how much it works. The demonstration of a clinically relevant effect must be the primary goal of every treatment. A clinically relevant effect is defined as the minimum achievable benefit, which may lead the medical doctor to change his strategy towards the patient, for example by recommending a particular therapy or treatment. The international scientific community calls the minimum achievable benefit with different names; one of the most common is the Minimal Important Difference (MID). The identification of MID is relevant for the clinician, for the agency that is paying the treatment, for the Regulatory Agency and is equally important for the patient for whose health these groups are responsible. MID for 6MWT has been estimated in subjects with different respiratory diseases and not. In Chronic Obstructive Pulmonary Diseases, a variation of 25 meters is considered significant. Recent studies have shown that asthmatic subjects cover a distance of about 500 meters during 6MWT, and that this distance improves after PR on average of 30-60 meters. Up to-day, however, the 6MWT MID in asthmatic patients has not been investigated.
The aim of this prospective study is to determine the MID for the 6MWT in subjects affected by asthma, regardless of the severity of the disease.
- Conditions
- Outcome, Asthma, Pulmonary Rehabilitation
- Being tested
- 6 minute walking test
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6 minute walking testDiagnostic test
change of 6MWT pre to post pulmonary rehabilitation
What is being measured
The primary outcome is the main question the study is designed to answer.
meters
define the MID for the 6MWT in subjects affected by bronchial asthma of different degrees of severity
Measured: 20 days
Secondary outcomes (3)
Asthma Control Questionnaire (ACQ)
to measure the degree of asthma control. Scores range between 0 (totally controlled) and 6 (severely uncontrolled).
Measured: 20 days
St George Respiratory Questionnaire (SGRQ)
to evaluate the quality of life. Score range 0 (better), 100 (worse)
Measured: 20 days
Chronic Obstructive Pulmonary Disease Assessment Test (CAT)
to evaluate the health status. Score range 0 (better), 40 (worse)
Measured: 20 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2019
- Study start16 Apr 2019
- Primary completion1 Aug 2020
- Study completion1 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OutcomeStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maugeri Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Università degli Studi di Sassari
- Responsible party
- Principal investigator, elisabetta zampogna, Maugeri Foundation
- Investigators
- Antonio Spanevello, Prof, Study director, Maugeri Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03922789
- Sponsor's protocol ID
- 2279 CE
- Status last verified
- Aug 2020
- First submitted
- 17 Apr 2019
- Last updated
- 4 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: no decision till now about plan to share
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimal Important Difference of Walking Test in Subjects With Bronchial Asthma
- ClinicalTrials.gov ID
- NCT03922789
- Acronym / sponsor ID
- 2279 CE
- Conditions
- Outcome, Asthma, Pulmonary Rehabilitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Maugeri FoundationUniversity, hospital or other
- Collaborators
- Università degli Studi di Sassari
- Study start
- 16 Apr 2019 (actual)
- Primary completion
- 1 Aug 2020 (actual)
- Study completion
- 1 Aug 2020 (actual)
- First posted
- 22 Apr 2019 (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.
The Six Minute Walking Test (6MWT) efficiently represents the exercise capacity in subjects with chronic respiratory disease, as asthma. The variation of the walking distance is a parameter used to evaluate the effectiveness of pharmacologic ando non-pharmacologic interventions, as Pulmonary Rehabilitation (PR). However, statistically significant changes in the walking distance do not always represent clinically significant variations.The aim of this prospective study is to determine the Minimal Important Difference (MID) for the 6MWT in subjects affected by asthma, regardless of the severity of the disease.
Detailed description
The Six Minute Walking Test (6MWT) efficiently represents the exercise capacity in subjects with chronic respiratory disease, as asthma. The variation of the walking distance is a parameter used to evaluate the effectiveness of pharmacologic and non-pharmacologic interventions, asPulmonary Rehabilitation (PR). However, statistically significant changes in the walking distance do not always represent clinically significant variations. For this reason, it is important to understand in terms of clinical impact, how to interpret the 6MWT when the walking distance changes over time in the same subject (for example, at the beginning and after PR) or when it differs between subjects (some subjects may improve more and some subjects less). It is not enough to state that the intervention works, it is necessary to say how much it works. The demonstration of a clinically relevant effect must be the primary goal of every treatment. A clinically relevant effect is defined as the minimum achievable benefit, which may lead the medical doctor to change his strategy towards the patient, for example by recommending a particular therapy or treatment. The international scientific community calls the minimum achievable benefit with different names; one of the most common is the Minimal Important Difference (MID). The identification of MID is relevant for the clinician, for the agency that is paying the treatment, for the Regulatory Agency and is equally important for the patient for whose health these groups are responsible. MID for 6MWT has been estimated in subjects with different respiratory diseases and not. In Chronic Obstructive Pulmonary Diseases, a variation of 25 meters is considered significant. Recent studies have shown that asthmatic subjects cover a distance of about 500 meters during 6MWT, and that this distance improves after PR on average of 30-60 meters. Up to-day, however, the 6MWT MID in asthmatic patients has not been investigated.
The aim of this prospective study is to determine the MID for the 6MWT in subjects affected by asthma, regardless of the severity of the disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects hospitalized in a Rehabilitation Center to complete a pulmonary rehabilitation programme
Key inclusion criteria (3 listed)
- Documented diagnosis of asthma according to the current guidelines "Global Initiative for Asthma (GINA)
- In therapy with inhaled and/or oral drugs ≥30 days
- Signature of Informed Consent.
Key exclusion criteria (3 listed)
- Concomitant pathologies with severe short term prognosis.
- Documented Chronic Obstructive Pulmonary Disease diagnosis.
- Inability to perform the 6 Minute Walking Test
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 |
|---|---|---|
| 6 minute walking testchange of 6MWT pre to post pulmonary rehabilitation | Diagnostic test | – |
Primary outcome
meters
Time frame: 20 days
define the MID for the 6MWT in subjects affected by bronchial asthma of different degrees of severity
3 secondary outcomes
Asthma Control Questionnaire (ACQ)
Time frame: 20 days
St George Respiratory Questionnaire (SGRQ)
Time frame: 20 days
Chronic Obstructive Pulmonary Disease Assessment Test (CAT)
Time frame: 20 days
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 4 Aug 2020.
- Individual participant dataSharing planned: Undecided. no decision till now about plan to share
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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.
Antonio Spanevello, Prof study director
Maugeri Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Outcome and Asthma, run by Maugeri Foundation 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 3 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 4 Aug 2020. 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?
meters (time frame: 20 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Aug 2020.