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

Walking, Difficulty Clinical Trial

— TDM6  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04541511
• Other study ID #: 2020_0047
• Status: Completed
• Phase: N/A
• Start date: August 28, 2020
• Est. completion date: February 27, 2022

Study information

• Verified date: August 2022
• Source: Hopital Foch
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: February 27, 2022
• Est. primary completion date: February 26, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Mobility Limitation
• Walking, Difficulty

Intervention

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.
• 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.

Locations

Country	Name	City	State
France	Hopital Foch	Suresnes	Ile-de-France

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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]
Secondary	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]
Secondary	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]
Secondary	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]