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Minimal Important Difference of Walking Test in Subjects With Bronchial Asthma

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ClinicalTrials.gov Identifier: NCT03922789
Recruitment Status : Recruiting
First Posted : April 22, 2019
Last Update Posted : April 30, 2019
Sponsor:
Collaborator:
University of Sassari, Italy
Information provided by (Responsible Party):
elisabetta zampogna, Maugeri Foundation

Brief 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). 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.

Condition or disease Intervention/treatment
Outcome Asthma Pulmonary Rehabilitation Diagnostic Test: 6 minute walking test

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.


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Study Type : Observational
Estimated Enrollment : 36 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Minimal Important Difference of Walking Test in Subjects With Bronchial Asthma
Actual Study Start Date : April 16, 2019
Estimated Primary Completion Date : October 30, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma


Intervention Details:
  • Diagnostic Test: 6 minute walking test
    change of 6MWT pre to post pulmonary rehabilitation


Primary Outcome Measures :
  1. meters [ Time Frame: 20 days ]
    define the MID for the 6MWT in subjects affected by bronchial asthma of different degrees of severity


Secondary Outcome Measures :
  1. Asthma Control Questionnaire (ACQ) [ Time Frame: 20 days ]
    to measure the degree of asthma control. Scores range between 0 (totally controlled) and 6 (severely uncontrolled).

  2. St George Respiratory Questionnaire (SGRQ) [ Time Frame: 20 days ]
    to evaluate the quality of life. Score range 0 (better), 100 (worse)

  3. Chronic Obstructive Pulmonary Disease Assessment Test (CAT) [ Time Frame: 20 days ]
    to evaluate the health status. Score range 0 (better), 40 (worse)



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects hospitalized in a Rehabilitation Center to complete a pulmonary rehabilitation programme
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Concomitant pathologies with severe short term prognosis.
  • Documented Chronic Obstructive Pulmonary Disease diagnosis.
  • Inability to perform the 6 Minute Walking Test

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03922789


Contacts
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Contact: Elisabetta Zampogna +39 0331 829503 elisabetta.zampogna@icsmaugeri.it
Contact: Dina Visca, MD +39 0331 829597 dina.visca@icsmaugeri.it

Locations
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Italy
Istituti Clinici Scientifici Maugeri Recruiting
Tradate, VA, Italy, 21049
Contact: Elisabetta Zampogna, M.Sc.    +39 0331829599    elisabetta.zampogna@fsm.it   
Sponsors and Collaborators
Maugeri Foundation
University of Sassari, Italy
Investigators
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Study Director: Antonio Spanevello, Prof Maugeri Foundation

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Responsible Party: elisabetta zampogna, Principal Investigator, Maugeri Foundation
ClinicalTrials.gov Identifier: NCT03922789     History of Changes
Other Study ID Numbers: 2279 CE
First Posted: April 22, 2019    Key Record Dates
Last Update Posted: April 30, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: no decision till now about plan to share

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases