Walking, Difficulty Clinical Trial
— TDM6Official title:
Comparison of the 6-minute Walking Test in a Corridor and on a Non-motorized Treadmill, Feasibility Study
Verified date | August 2022 |
Source | Hopital Foch |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
France | Hopital Foch | Suresnes | Ile-de-France |
Lead Sponsor | Collaborator |
---|---|
Hopital Foch |
France,
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] |
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