Skip to main content
OpenTrials
Completed

NCT Number: NCT04033783

Impact of Walking Behind the COPD Patient on 6MWD

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.

Completed

Looking for future studies?

Notify Me

Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Berner Rehazentrum AG, Heiligenschwendi, Canton of Bern, Switzerland

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

6MWT - accompanied

Other

Assessor walks behind the patient

6MWT - not accompanied

Other

Assessor does not walk behind the patient

Primary outcomes

  1. Exercise capacity

    Time frame: During pulmonary rehabilitation, approximately 14 days

    Difference in six minute walk test distance between the two experimental conditions (in meter)

Secondary outcomes

  1. Six minute walk test

    Time frame: During pulmonary rehabilitation, approximately 14 days

    Difference in patient reported perception during the two different walking tests assessed with a self-administered questionnaire. The questionnaire contains 5 questions with five response categories: 1=not at all; 2 = somewhat; 3=modestly; 4=strongly; 5= very strongly

Other outcomes

  1. Oxygen saturation

    Time frame: During pulmonary rehabilitation, approximately 14 days

    Difference in oxygen saturation profiles between the two experimental conditions

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

The Impact of Walking Behind the Patient on Six-Minute Walk Test Distance in Chronic Obstructive Pulmonary Disease: a Randomized Cross-over Study

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jul 26, 2019
Registry last updated
Dec 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.