Impact of Walking Behind the COPD Patient on 6MWD

NCT04033783 | Completed

• 1 other identifier: 2019-00827
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 2

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.

Conditions

COPD

Keywords

Six minute walk test; Field test; Exercise capacity; Functional capacity

Outcome Measures

Primary Outcomes (1)

• Exercise capacity

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

  During pulmonary rehabilitation, approximately 14 days

Secondary Outcomes (1)

• Six minute walk test

  During pulmonary rehabilitation, approximately 14 days

Other Outcomes (1)

• Oxygen saturation

  During pulmonary rehabilitation, approximately 14 days

Study Arms (2)

6MWT - assessor walks behind the patient

EXPERIMENTAL

In this experimental condition, the assessor walks behind the patient to continuously measure oxygen saturation during the test (recommended procedure)

Other: 6MWT - accompanied

6MWT - assessor does not walk behind the patient

ACTIVE COMPARATOR

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

Interventions

6MWT - accompanied OTHER

Assessor walks behind the patient

6MWT - assessor walks behind the patient

6MWT - not accompanied OTHER

Assessor does not walk behind the patient

6MWT - assessor does not walk behind the patient

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a diagnosis of COPD according to GOLD II-IV (FEV1/FVC \< 0.7, FEV1%Norm \< 80%)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (2)

Berner Rehazentrum AG

Heiligenschwendi, Canton of Bern, 3625, Switzerland

Location

University of Zurich

Zurich, 8001, Switzerland

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Anja Frei, PhD

  University of Zurich, EBPI, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2019
• First Posted: July 26, 2019
• Study Start: September 18, 2019
• Primary Completion: December 16, 2019
• Study Completion: December 16, 2019
• Last Updated: December 20, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

CH (2)