Walking, DifficultyTDM6NCT04541511
Comparison of the 6-minute Walking Test in a Corridor and on a Non-motorized Treadmill
A study testing 6-minutes walking test on a corridor and 6-minutes walking test on a treadmill in people with Walking, Difficulty, run by Hopital Foch at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Walking, Difficulty
- What is being tested?
- 6-minutes walking test on a corridor and 6-minutes walking test on a treadmill
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteFrance
- Study dates
- 28 Aug 2020to 27 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the 6-minute Walking Test in a Corridor and on a Non-motorized Treadmill, Feasibility Study
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.
Read the 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.
- Conditions
- Walking, Difficulty
- Being tested
- 6-minutes walking test on a corridor, 6-minutes walking test on a treadmill
- Keywords
- 6-minutes walking test; 6-WT
- Medical subject headings
- Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6-minutes walking test on a corridorDiagnostic 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 treadmillDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy subject | Experimental | 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. Receives: Diagnostic Test: 6-minutes walking test on a corridor; Diagnostic Test: 6-minutes walking test on a treadmill |
| Patients | Experimental | 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. Receives: Diagnostic Test: 6-minutes walking test on a treadmill |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: [length on the test - 1 day]
Secondary outcomes (4)
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.
Measured: [length on the test - 1 day]
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.
Measured: [length on the test - 1 day]
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.
Measured: [length on the test - 1 day]
Evaluate patients' perception of the use of the new method.
Non-standardized questionnaire assessing the acceptability and ease of use of the new method
Measured: [length on the test - 1 day]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2020
- Study start28 Aug 2020
- Primary completion26 Feb 2022
- Study completion27 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Walking, DifficultyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- * 31 healthy subjects * 6 patients
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nina GOUDIER, Principal investigator, Hopital Foch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04541511
- Sponsor's protocol ID
- 2020_0047
- Acronym
- TDM6
- Status last verified
- Aug 2022
- First submitted
- 1 Sep 2020
- Last updated
- 3 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the 6-minute Walking Test in a Corridor and on a Non-motorized Treadmill, Feasibility Study
- ClinicalTrials.gov ID
- NCT04541511
- Acronym / sponsor ID
- TDM6 / 2020_0047
- Conditions
- Walking, Difficulty
- Keywords
- 6-minutes walking test; 6-WT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- 28 Aug 2020 (actual)
- Primary completion
- 26 Feb 2022 (actual)
- Study completion
- 27 Feb 2022 (actual)
- First posted
- 9 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- * 31 healthy subjects * 6 patients
| Arm | Type | Receives |
|---|---|---|
| Healthy subject | Experimental | Diagnostic Test: 6-minutes walking test on a corridor, Diagnostic Test: 6-minutes walking test on a treadmillHealthy 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 | Experimental | Diagnostic Test: 6-minutes walking test on a treadmillPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 6-minutes walking test on a corridor6-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. | Diagnostic test | Healthy subject |
| 6-minutes walking test on a treadmill6-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. | Diagnostic test | Healthy subject, Patients |
Primary outcome
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.
4 secondary outcomes
Evaluate the change in heart rate during the two test methods in healthy subjects
Time frame: [length on the test - 1 day]
Evaluate the change in oxygen saturation during the two test methods in healthy subjects.
Time frame: [length on the test - 1 day]
To measure the perception of exertion after both test methods in healthy subjects.
Time frame: [length on the test - 1 day]
Evaluate patients' perception of the use of the new method.
Time frame: [length on the test - 1 day]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nina GOUDIER principal investigator
Hopital Foch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 6-minutes walking test on a corridor and 6-minutes walking test on a treadmill in people with Walking, Difficulty, run by Hopital Foch at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: [length on the test - 1 day]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2022.