NCT04541511

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 28, 2020

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

September 1, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 9, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 26, 2022

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 27, 2022

Completed
Last Updated

August 3, 2022

Status Verified

August 1, 2022

Enrollment Period

1.5 years

First QC Date

September 1, 2020

Last Update Submit

August 2, 2022

Conditions

Walking, Difficulty

Keywords

6-minutes walking test; 6-WT

Outcome Measures

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.

    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 Outcomes (4)

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

    [length on the test - 1 day]

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

    [length on the test - 1 day]

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

    [length on the test - 1 day]

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

    [length on the test - 1 day]

Study Arms (2)

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.

Diagnostic Test: 6-minutes walking test on a corridorDiagnostic 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.

Diagnostic Test: 6-minutes walking test on a treadmill

Interventions

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.

Healthy subject
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.

Healthy subjectPatients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Foch

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

Location

MeSH Terms

Conditions

Mobility Limitation

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Nina GOUDIER

    Hopital Foch

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: * 31 healthy subjects * 6 patients
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2020

First Posted

September 9, 2020

Study Start

August 28, 2020

Primary Completion

February 26, 2022

Study Completion

February 27, 2022

Last Updated

August 3, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)