NCT03922789

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 16, 2019

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

April 17, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 22, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

August 4, 2020

Status Verified

August 1, 2020

Enrollment Period

1.3 years

First QC Date

April 17, 2019

Last Update Submit

August 3, 2020

Conditions

OutcomeAsthmaPulmonary Rehabilitation

Outcome Measures

Primary Outcomes (1)

  • meters

    define the MID for the 6MWT in subjects affected by bronchial asthma of different degrees of severity

    20 days

Secondary Outcomes (3)

  • Asthma Control Questionnaire (ACQ)

    20 days

  • St George Respiratory Questionnaire (SGRQ)

    20 days

  • Chronic Obstructive Pulmonary Disease Assessment Test (CAT)

    20 days

Interventions

6 minute walking testDIAGNOSTIC_TEST

change of 6MWT pre to post pulmonary rehabilitation

Eligibility Criteria

Age45 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituti Clinici Scientifici Maugeri

Tradate, VA, 21049, Italy

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Antonio Spanevello, Prof

    Maugeri Foundation

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 17, 2019

First Posted

April 22, 2019

Study Start

April 16, 2019

Primary Completion

August 1, 2020

Study Completion

August 1, 2020

Last Updated

August 4, 2020

Record last verified: 2020-08

Locations

IT(1)