Impact of Walking Behind the COPD Patient on 6MWD

COPD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04033783
• Other study ID #: 2019-00827
• Status: Completed
• Phase: N/A
• Start date: September 18, 2019
• Est. completion date: December 16, 2019

Study information

• Verified date: December 2019
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: December 16, 2019
• Est. primary completion date: December 16, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• COPD

Intervention

Other:
• 6MWT - accompanied
Assessor walks behind the patient
• 6MWT - not accompanied
Assessor does not walk behind the patient

Locations

Country	Name	City	State
Switzerland	Berner Rehazentrum AG	Heiligenschwendi	Bern
Switzerland	University of Zurich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Oxygen saturation	Difference in oxygen saturation profiles between the two experimental conditions	During pulmonary rehabilitation, approximately 14 days
Primary	Exercise capacity	Difference in six minute walk test distance between the two experimental conditions (in meter)	During pulmonary rehabilitation, approximately 14 days
Secondary	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