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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.

Minimal Important Difference of Walking Test in Subjects With Bronchial Asthma

Clinicaltrials.gov identifier NCT03922789

Recruitment Status Completed

First Posted April 22, 2019

Last update posted August 4, 2020

Study Description

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:Outcome
    Pulmonary Rehabilitation
    Asthma
  • Intervention/Treatment: Diagnostic Test: 6 minute walking test
  • Phase: N/A
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
  • Study Type: Observational
  • Actual 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 2019
  • Actual Primary Completion Date: August 2020
  • Actual Study Completion Date: August 2020
Outcome Measures
  • 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)
Eligibility Criteria
  • Ages Eligible for Study: 45 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

Contacts and Locations
Contacts
Locations

Italy, VA
Istituti Clinici Scientifici Maugeri
Tradate

Sponsors and Collaborators

Maugeri Foundation

University of Sassari, Italy

Investigators

Study Director: Antonio Spanevello, Prof Maugeri Foundation

More Information
  • Responsible Party: 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: August 4, 2020
  • Last Verified: August 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: Undecided
  • Plan Description: no decision till now about plan to share
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Asthma