Impact of Walking Behind the COPD Patient on 6MWD

Study Overview
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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.

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

Conditions
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COPD

Intervention / Treatment
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* Other: 6MWT - accompanied
* Other: 6MWT - not accompanied


Participation Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 6MWT - assessor walks behind the patient<br>In this experimental condition, the assessor walks behind the patient to continuously measure oxygen saturation during the test (recommended procedure) | Other: 6MWT - accompanied<br>* Assessor walks behind the patient<br>|
| Active Comparator: 6MWT - assessor does not walk behind the patient<br>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. | Other: 6MWT - not accompanied<br>* Assessor does not walk behind the patient<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exercise capacity | Difference in six minute walk test distance between the two experimental conditions (in meter) | During pulmonary rehabilitation, approximately 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Six minute walk test | 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 | During pulmonary rehabilitation, approximately 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Six minute walk test, Field test, Exercise capacity, Functional capacity