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Completed

NCT Number: NCT04541511

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

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.

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Key information

Conditions

Walking, Difficulty Mobility Limitation Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hopital Foch

Suresnes, Île-de-France Region, 92150, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

6-minutes walking test on a corridor

Diagnostic Test

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

Diagnostic Test

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 outcomes

  1. 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.

    Time frame: [length on the test - 1 day]

    Total distance on the 6-WT on a corridor and on a non-motorized treadmill in healthy subjects.

Secondary outcomes

  1. Evaluate the change in heart rate during the two test methods in healthy subjects

    Time frame: [length on the test - 1 day]

    Heart rate before and after each test : 6-WT on a corridor and on a non-motorized treadmill in healthy subjects.

  2. Evaluate the change in oxygen saturation during the two test methods in healthy subjects.

    Time frame: [length on the test - 1 day]

    Oxygen saturation before and after each test : 6-WT on a corridor and on a non-motorized treadmill in healthy subjects.

  3. To measure the perception of exertion after both test methods in healthy subjects.

    Time frame: [length on the test - 1 day]

    Borg scale before and after each test : 6-WT on a corridor and on a non-motorized treadmill in healthy subjects.

  4. Evaluate patients' perception of the use of the new method.

    Time frame: [length on the test - 1 day]

    Non-standardized questionnaire assessing the acceptability and ease of use of the new method

Sponsors and collaborators

Lead sponsor

Hopital Foch

Other

Registry information

Official study title

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

Acronym: TDM6

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Sep 9, 2020
Registry last updated
Aug 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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