Comparison of the 6-minute Walking Test in a Corridor and on a Non-motorized Treadmill (TDM6)

Comparison of the 6-minute Walking Test in a Corridor and on a Non-motorized Treadmill, Feasibility Study

Evaluation of the equivalence of 6-minute walking test performed on a non-motorized treadmill to the reference test : a 6-minute walking test on a corridor.

Study Overview

• Status: Completed
• Conditions: Walking, Difficulty
• Intervention / Treatment: Diagnostic test: 6-minutes walking test on a corridor; Diagnostic test: 6-minutes walking test on a treadmill

Detailed Description

The Six-Minute Walk Test (6-WT) is a standardized test to assess a person's functional ability to walk as far as they can in six minutes. It is widely used in the assessment of functional disability in response to medical intervention in respiratory and cardiac conditions.

This test requires a corridor measuring between 20 and 30 metres and does not require any special technical equipment or training.

While the test appears simple to set up, factors such as the length or width of the corridor, and external disruptive elements, may affect the results. Indeed, the configuration of the test site plays a role in the test result. For example, the distance traveled in a 6-minute walking test is greater on a continuous circuit than in a lane that requires people to walk back and forth or when others are using the lane (zigzags, slowdowns). In a hospital setting, while it is easy to find a corridor that is long enough, it is not always possible to dedicate it exclusively to walking tests.

An alternative would be to perform this test on a non-motorized treadmill to avoid these biases. The main objective of this study is to evaluate the equivalence of a 6-minute walking test performed on a non-motorized treadmill to the reference test in healthy subjects. In addition, a small number of patients will be invited to perform a 6-minute CT scan on a non-motorized treadmill in order to first evaluate the perception and acceptability of this new method in this population (seniors, pathologies). If the results are conclusive, a similar study with patients only will be performed.

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Ile-de-France
    • Suresnes, Ile-de-France, France, 92150
      • Hopital FOCH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy subject 18 years of age or older
• Have signed a consent form
• Be affiliated with a Health Insurance Plan
• Having a pathology requiring the monitoring of the evolution of the distance performed by 6-WT (patients only)

Exclusion Criteria:

• Being unable to walk for several minutes for physical, neurological or psychological reasons
• Recent acute coronary syndrome
• Rest tachycardia greater than 120 pulses/min.
• Resting blood pressure greater than 180/100 mmHg
• Pregnant, Parturient or Nursing Women
• Persons deprived of liberty: minors or adults who are subject to a legal protection measure or who are unable to express their consent.
• Subjects under guardianship or curatorship.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Healthy subject; Healthy subject will be asked to performed two 6-minutes walking test : one in a corridor and one on the non-motorized treadmill. Oxygen saturation, heart rate and Borg score will be collected before and after each test.	Diagnostic test: 6-minutes walking test on a corridor; 6-minutes walking test on a corridor : patient will be asked to achieve the longest possible distance without running. He/she will be allowed to take breaks if he/she feels the need to do so.; Diagnostic test: 6-minutes walking test on a treadmill; 6-minutes walking test on a treadmill : patient will be asked to achieve the longest possible distance without running on the treadmill. He/she will be allowed to take breaks if he/she feels the need to do so.
Experimental: Patients; Patients will be asked to to performed a 6-minutes walking test on the non-motorized treadmill and to answer a questionnaire regarding the acceptability and ease of use of the new method.	Diagnostic test: 6-minutes walking test on a treadmill; 6-minutes walking test on a treadmill : patient will be asked to achieve the longest possible distance without running on the treadmill. He/she will be allowed to take breaks if he/she feels the need to do so.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess the equivalence of walking distances obtained with the 6-minute walk test on a non-motorized treadmill to the baseline (6-WT on a corridor) test in healthy subjects.	Total distance on the 6-WT on a corridor and on a non-motorized treadmill in healthy subjects.	[length on the test - 1 day]

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the change in heart rate during the two test methods in healthy subjects	Heart rate before and after each test : 6-WT on a corridor and on a non-motorized treadmill in healthy subjects.	[length on the test - 1 day]
Evaluate the change in oxygen saturation during the two test methods in healthy subjects.	Oxygen saturation before and after each test : 6-WT on a corridor and on a non-motorized treadmill in healthy subjects.	[length on the test - 1 day]
To measure the perception of exertion after both test methods in healthy subjects.	Borg scale before and after each test : 6-WT on a corridor and on a non-motorized treadmill in healthy subjects.	[length on the test - 1 day]
Evaluate patients' perception of the use of the new method.	Non-standardized questionnaire assessing the acceptability and ease of use of the new method	[length on the test - 1 day]

Collaborators and Investigators

• Sponsor: Hopital Foch
• Investigators: Principal Investigator: Nina GOUDIER, Hopital FOCH

Study record dates

Study Major Dates

• Study Start (Actual): August 28, 2020
• Primary Completion (Actual): February 26, 2022
• Study Completion (Actual): February 27, 2022

Study Registration Dates

• First Submitted: September 1, 2020
• First Submitted That Met QC Criteria: September 1, 2020
• First Posted (Actual): September 9, 2020

Study Record Updates

• Last Update Posted (Actual): August 3, 2022
• Last Update Submitted That Met QC Criteria: August 2, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: 6-minutes walking test; 6-WT
• Additional Relevant MeSH Terms: Mobility Limitation
• Other Study ID Numbers: 2020_0047

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