Clinical trial NCT04541511: Comparison of the 6-minute Walking Test in a Corridor and on a Non-motorized Treadmill
Official title: Comparison of the 6-minute Walking Test in a Corridor and on a Non-motorized Treadmill, Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Walking, Difficulty
Keywords: 6-minutes walking test; 6-WT
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2020-09-09
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: * 31 healthy subjects
* 6 patients
Primary purpose: OTHER

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: [length on the test - 1 day]
Secondary outcomes:
measure: Evaluate the change in heart rate during the two test methods in healthy subjects
timeFrame: [length on the test - 1 day]
measure: Evaluate the change in oxygen saturation during the two test methods in healthy subjects.
timeFrame: [length on the test - 1 day]
measure: To measure the perception of exertion after both test methods in healthy subjects.
timeFrame: [length on the test - 1 day]
measure: Evaluate patients' perception of the use of the new method.
timeFrame: [length on the test - 1 day]
Other outcomes:
Locations:
city: Suresnes
country: France
facility: Hopital Foch
state: Ile-de-France
Study officials:
affiliation: Hopital Foch
name: Nina GOUDIER
role: PRINCIPAL_INVESTIGATOR
References: