Comparison of the 6-minute Walking Test in a Corridor and on a Non-motorized Treadmill (TDM6)
Primary Purpose
Walking, Difficulty
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
6-minutes walking test on a corridor
6-minutes walking test on a treadmill
Sponsored by
About this trial
This is an interventional other trial for Walking, Difficulty focused on measuring 6-minutes walking test; 6-WT
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.
Sites / Locations
- Hopital Foch
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Healthy subject
Patients
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Evaluate patients' perception of the use of the new method.
Non-standardized questionnaire assessing the acceptability and ease of use of the new method
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04541511
Brief Title
Comparison of the 6-minute Walking Test in a Corridor and on a Non-motorized Treadmill
Acronym
TDM6
Official Title
Comparison of the 6-minute Walking Test in a Corridor and on a Non-motorized Treadmill, Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
August 28, 2020 (Actual)
Primary Completion Date
February 26, 2022 (Actual)
Study Completion Date
February 27, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hopital Foch
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Walking, Difficulty
Keywords
6-minutes walking test; 6-WT
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
31 healthy subjects
6 patients
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Healthy subject
Arm Type
Experimental
Arm Description
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.
Arm Title
Patients
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
6-minutes walking test on a corridor
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
6-minutes walking test on a treadmill
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Description
Total distance on the 6-WT on a corridor and on a non-motorized treadmill in healthy subjects.
Time Frame
[length on the test - 1 day]
Secondary Outcome Measure Information:
Title
Evaluate the change in heart rate during the two test methods in healthy subjects
Description
Heart rate before and after each test : 6-WT on a corridor and on a non-motorized treadmill in healthy subjects.
Time Frame
[length on the test - 1 day]
Title
Evaluate the change in oxygen saturation during the two test methods in healthy subjects.
Description
Oxygen saturation before and after each test : 6-WT on a corridor and on a non-motorized treadmill in healthy subjects.
Time Frame
[length on the test - 1 day]
Title
To measure the perception of exertion after both test methods in healthy subjects.
Description
Borg scale before and after each test : 6-WT on a corridor and on a non-motorized treadmill in healthy subjects.
Time Frame
[length on the test - 1 day]
Title
Evaluate patients' perception of the use of the new method.
Description
Non-standardized questionnaire assessing the acceptability and ease of use of the new method
Time Frame
[length on the test - 1 day]
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nina GOUDIER
Organizational Affiliation
Hopital Foch
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital Foch
City
Suresnes
State/Province
Ile-de-France
ZIP/Postal Code
92150
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
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Comparison of the 6-minute Walking Test in a Corridor and on a Non-motorized Treadmill
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