NCT02348151

Brief Summary

It is still not clearly known whether doing the walk test in a course is different from doing it on a treadmill in the lack of a ten-meter-long corridor. In case of a positive outcome in this study, we will have an alternative for this test in places where there is not enough room, benefiting the assessment of COPD patients' functional capacity. In the literature, there are still some controversies about performing the test on a treadmill or in a corridor and whether there is interference with the distance walked. Our hypothesis is that there is no interference with the distance walked, and thus we have one more option to perform the test in case there is no 10-meter corridor available.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
47

participants targeted

Target at P25-P50 for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Jan 2014

Typical duration for not_applicable chronic-obstructive-pulmonary-disease

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2014

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 22, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 28, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

March 10, 2015

Status Verified

March 1, 2015

Enrollment Period

1.2 years

First QC Date

January 22, 2015

Last Update Submit

March 9, 2015

Conditions

Keywords

COPDSWTiTreadmill

Outcome Measures

Primary Outcomes (1)

  • The distance reached in shuttle walk test

    two year

Study Arms (2)

Treadmill

EXPERIMENTAL

The Shuttle is going to play on treadmill

Other: Treadmill

Corridor

ACTIVE COMPARATOR

The Shuttle is going to play on corridor

Other: Corridor

Interventions

The volunteers will perform the shuttle walk test on the treadmill

Treadmill

The volunteers will perform the shuttle walk test on the corridor

Corridor

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • clinically stable
  • not dependent on oxygen to exercise
  • diagnosis of COPD according to the GOLD

You may not qualify if:

  • cognitive deficit or musculoskeletal
  • in process of exacerbation
  • have performed pulmonary rehabilitation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Patricia Lira dos Santos

Mogi das Cruzes, São Paulo/Mogi Das Cruzes, 08773535, Brazil

RECRUITING

Related Publications (2)

  • Singh SJ, Morgan MD, Scott S, Walters D, Hardman AE. Development of a shuttle walking test of disability in patients with chronic airways obstruction. Thorax. 1992 Dec;47(12):1019-24. doi: 10.1136/thx.47.12.1019.

  • Stevens D, Elpern E, Sharma K, Szidon P, Ankin M, Kesten S. Comparison of hallway and treadmill six-minute walk tests. Am J Respir Crit Care Med. 1999 Nov;160(5 Pt 1):1540-3. doi: 10.1164/ajrccm.160.5.9808139.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisRespiratory Function TestsDiagnostic Techniques, Respiratory SystemErgometryInvestigative Techniques

Study Officials

  • Patrícia L Santos, Professional

    551198408-4006

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fernanda C Lanza, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Patricia Lira dos Santos

Study Record Dates

First Submitted

January 22, 2015

First Posted

January 28, 2015

Study Start

January 1, 2014

Primary Completion

March 1, 2015

Study Completion

June 1, 2016

Last Updated

March 10, 2015

Record last verified: 2015-03

Locations