Impact of Walking Behind the COPD Patient on 6MWD

Not Applicable

Completed

• Conditions: COPD
• Interventions: Other: 6MWT - accompanied; Other: 6MWT - not accompanied

• Registration Number: NCT04033783
• Lead Sponsor: University of Zurich

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2019-07-08
• Study First Submitted QC: 2019-07-25
• Study First Posted: 2019-07-26
• Study Start: 2019-09-18
• Status Verified: 2019-12
• Primary Completion: 2019-12-16
• Study Completion: 2019-12-16
• Last Update Submitted: 2019-12-19
• Last Update Posted: 2019-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
6MWT - assessor walks behind the patient	6MWT - accompanied	In this experimental condition, the assessor walks behind the patient to continuously measure oxygen saturation during the test (recommended procedure)
6MWT - assessor does not walk behind the patient	6MWT - not accompanied	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.

Primary Outcome Measures

Name	Time	Method
Exercise capacity	During pulmonary rehabilitation, approximately 14 days	Difference in six minute walk test distance between the two experimental conditions (in meter)

Secondary Outcome Measures

Name	Time	Method
Six minute walk test	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

Trial Locations

Locations (2)

University of Zurich; 🇨🇭 Zurich, Switzerland

Berner Rehazentrum AG; 🇨🇭 Heiligenschwendi, Bern, Switzerland