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Impact of Walking Behind the COPD Patient on 6MWD

NCT ID: NCT04033783

Last Updated: 2019-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-18

Study Completion Date

2019-12-16

Brief Summary

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The six-minute walk test (6MWT) is a well established field exercise test to assess the functional exercise capacity in chronic obstructive pulmonary disease (COPD). The objective of this study is to assess the impact of walking behind the patient on 6MWT distance in patients with COPD.

Detailed Description

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In a single-center, randomized crossover study, the investigators aim to elucidate whether there is a difference in the 6MWT distance when the assessor walks behind the patient compared to the patient walking alone.

Patients with COPD referred for pulmonary rehabilitation will be invited to perform an accompanied 6MWT (assessor walks behind the patient) and unaccompanied 6MWT (assessor does not walk behind the patient) in random order.

The tests will be performed at the end of a pulmonary rehabilitation program, after patients are familiarised with the 6MWT testing procedure and learning effects can be excluded.

Conditions

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COPD

Keywords

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Six minute walk test Field test Exercise capacity Functional capacity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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6MWT - assessor walks behind the patient

In this experimental condition, the assessor walks behind the patient to continuously measure oxygen saturation during the test (recommended procedure)

Group Type EXPERIMENTAL

6MWT - accompanied

Intervention Type OTHER

Assessor walks behind the patient

6MWT - assessor does not walk behind the patient

In this experimental condition, the assessor does not walk behind the patient. The patient carries the pulse oximeter to continuously measure oxygen saturation during the test.

Group Type ACTIVE_COMPARATOR

6MWT - not accompanied

Intervention Type OTHER

Assessor does not walk behind the patient

Interventions

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6MWT - accompanied

Assessor walks behind the patient

Intervention Type OTHER

6MWT - not accompanied

Assessor does not walk behind the patient

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients with a diagnosis of COPD according to GOLD II-IV (FEV1/FVC \< 0.7, FEV1%Norm \< 80%)

Exclusion Criteria

* Inability to perform a 6MWT when arriving at the clinic (e.g., lower limb joint surgery within preceding 3 months, unstable cardiac disease, predominant neurological limitations)
* Inability to understand the instructions of the 6MWT, either of language or cognitive reasons
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anja Frei, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Zurich, EBPI, Switzerland

Locations

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Berner Rehazentrum AG

Heiligenschwendi, Canton of Bern, Switzerland

Site Status

University of Zurich

Zurich, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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2019-00827

Identifier Type: -

Identifier Source: org_study_id