Minimal Important Difference of Walking Test in Subjects With Bronchial Asthma

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.

Study Overview

• Status: Completed
• Conditions: Asthma; Pulmonary Rehabilitation; Outcome
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 36

Contacts and Locations

Study Locations

• Italy
  • VA
    • Tradate, VA, Italy, 21049
      • Istituti Clinici Scientifici Maugeri

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 43 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects hospitalized in a Rehabilitation Center to complete a pulmonary rehabilitation programme

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
meters	define the MID for the 6MWT in subjects affected by bronchial asthma of different degrees of severity	20 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Asthma Control Questionnaire (ACQ)	to measure the degree of asthma control. Scores range between 0 (totally controlled) and 6 (severely uncontrolled).	20 days
St George Respiratory Questionnaire (SGRQ)	to evaluate the quality of life. Score range 0 (better), 100 (worse)	20 days
Chronic Obstructive Pulmonary Disease Assessment Test (CAT)	to evaluate the health status. Score range 0 (better), 40 (worse)	20 days

Collaborators and Investigators

• Sponsor: Maugeri Foundation
• Collaborators: University of Sassari, Italy
• Investigators: Study Director: Antonio Spanevello, Prof, Maugeri Foundation

Study record dates

Study Major Dates

• Study Start (Actual): April 16, 2019
• Primary Completion (Actual): August 1, 2020
• Study Completion (Actual): August 1, 2020

Study Registration Dates

• First Submitted: April 17, 2019
• First Submitted That Met QC Criteria: April 17, 2019
• First Posted (Actual): April 22, 2019

Study Record Updates

• Last Update Posted (Actual): August 4, 2020
• Last Update Submitted That Met QC Criteria: August 3, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: 2279 CE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: no decision till now about plan to share

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No