Minimal Important Difference of Walking Test in Subjects With Bronchial Asthma

Completed

• Conditions: Outcome; Asthma; Pulmonary Rehabilitation

• Registration Number: NCT03922789
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2019-04-16
• Study First Submitted: 2019-04-17
• Study First Submitted QC: 2019-04-17
• Study First Posted: 2019-04-22
• Status Verified: 2020-08
• Primary Completion: 2020-08-01
• Study Completion: 2020-08-01
• Last Update Submitted: 2020-08-03
• Last Update Posted: 2020-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
meters	20 days	define the MID for the 6MWT in subjects affected by bronchial asthma of different degrees of severity

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Istituti Clinici Scientifici Maugeri; 🇮🇹 Tradate, VA, Italy