Impact of Walking Behind the COPD Patient on 6MWD

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

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.

Study Overview

• Status: Completed
• Conditions: COPD
• Intervention / Treatment: Other: 6MWT - accompanied; Other: 6MWT - not accompanied

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 Type: Interventional
• Enrollment (Actual): 49
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Zurich, Switzerland, 8001
    • University of Zurich
  • Bern
    • Heiligenschwendi, Bern, Switzerland, 3625
      • Berner Rehazentrum AG

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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)	Other: 6MWT - accompanied; Assessor walks behind the patient
Active Comparator: 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.	Other: 6MWT - not accompanied; Assessor does not walk behind the patient

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxygen saturation	Difference in oxygen saturation profiles between the two experimental conditions	During pulmonary rehabilitation, approximately 14 days

Collaborators and Investigators

• Sponsor: University of Zurich
• Investigators: Principal Investigator: Anja Frei, PhD, University of Zurich, EBPI, Switzerland

Study record dates

Study Major Dates

• Study Start (Actual): September 18, 2019
• Primary Completion (Actual): December 16, 2019
• Study Completion (Actual): December 16, 2019

Study Registration Dates

• First Submitted: July 8, 2019
• First Submitted That Met QC Criteria: July 25, 2019
• First Posted (Actual): July 26, 2019

Study Record Updates

• Last Update Posted (Actual): December 20, 2019
• Last Update Submitted That Met QC Criteria: December 19, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: Field test; Exercise capacity; Functional capacity; Six minute walk test
• Other Study ID Numbers: 2019-00827

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No