Shuttle Walk Test Performed on a Treadmill Versus a Corridor in Patients With COPD

Analysis of Metabolic and Ventilatory Demands During the Shuttle Walk Test Performed on a Treadmill Versus a Corridor in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Lead Sponsor

University of Nove de Julho

Source

University of Nove de Julho

Oversight Info

Has Dmc

Yes

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.

Detailed Description

Spirometry tests will be performed using ULTIMA CPX equipment. Volunteers will perform the tests twice, on different days (see protocol description), in a corridor and on a treadmill, until reaching their limit of tolerance. In the test performed on the treadmill and in the one performed in the corridor, subjects will simultaneously use the VO 2000. And the volunteers will fill out the Saint George's Respiratory Questionnaire (SGRQ).

Overall Status

Unknown status

Start Date

2014-01-01

Completion Date

2016-06-01

Primary Completion Date

2015-03-01

Phase

N/A

Study Type

Interventional

Primary Outcome

Measure	Time Frame
The distance reached in shuttle walk test	two year

Enrollment

Condition

Chronic Obstructive Pulmonary Disease

Intervention

Intervention Type

Other

Intervention Name

Treadmill

Description

The volunteers will perform the shuttle walk test on the treadmill

Arm Group Label

Treadmill

Intervention Type

Other

Intervention Name

Corridor

Description

The volunteers will perform the shuttle walk test on the corridor

Arm Group Label

Corridor

Eligibility

Criteria

Inclusion Criteria: - clinically stable - not dependent on oxygen to exercise - diagnosis of COPD according to the GOLD Exclusion Criteria: - cognitive deficit or musculoskeletal - in process of exacerbation - have performed pulmonary rehabilitation

Gender

All

Minimum Age

18 Years

Maximum Age

85 Years

Healthy Volunteers

Overall Official

Last Name	Role	Affiliation
Patrícia L Santos, Professional	Principal Investigator	551198408-4006

Overall Contact

Last Name

Fernanda C Lanza, PhD

Phone

55113385-9241

Email

[email protected]

Location

Facility	Status	Contact	Investigator
Patricia Lira dos Santos Mogi das Cruzes São Paulo/Mogi das Cruzes 08773535 Brazil	Recruiting	Last Name: Patricia L Santos, Profissional Phone: 551198408-4006 Email: [email protected]	Last Name: Patricia L Santos, Profissional Role: Principal Investigator Last Name: Fernanda C Lanza, PhD Role: Sub-Investigator Last Name: Simone D Corso, PhD Role: Sub-Investigator

Location Countries

Country

Brazil

Verification Date

2015-03-01

Lastchanged Date

N/A

Firstreceived Date

N/A

Responsible Party

Responsible Party Type

Principal Investigator

Investigator Affiliation

University of Nove de Julho

Investigator Full Name

Patricia Lira dos Santos

Investigator Title

Patricia Lira dos Santos

Keywords

COPD

, SWTi

, Treadmill

Has Expanded Access

Condition Browse

Lung Diseases

, Lung Diseases, Obstructive

, Pulmonary Disease, Chronic Obstructive

Number Of Arms

Arm Group

Arm Group Label

Treadmill

Arm Group Type

Experimental

Description

The Shuttle is going to play on treadmill

Arm Group Label

Corridor

Arm Group Type

Active Comparator

Description

The Shuttle is going to play on corridor

Results Reference

Citation

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.

PMID

1494764

Citation

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.

PMID

10556117

Firstreceived Results Date

N/A

Acronym

(SWTiCOPD)

Firstreceived Results Disposition Date

N/A

Study Design Info

Allocation

Randomized

Intervention Model

Single Group Assignment

Masking

None (Open Label)

Study First Submitted

January 22, 2015

Study First Submitted Qc

January 22, 2015

Study First Posted

January 28, 2015

Last Update Submitted

March 9, 2015

Last Update Submitted Qc

March 9, 2015

Last Update Posted

March 10, 2015

Last Known Status

Recruiting

ClinicalTrials.gov processed this data on January 15, 2020

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.

Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.

Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.

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Analysis of Metabolic and Ventilatory Demands During the Shuttle Walk Test Performed on a Treadmill Versus a Corridor in Patients With Chronic Obstructive Pulmonary Disease (COPD)