Validation of the Two-minute Walk Test and the Ten-meter Walk Test in Individuals With Cancer (2MWTOnco)

December 30, 2022 updated by: Aline Reinmann

Comparison of the 2MWT, the 10MeWT and the 6MWT in Individuals With Cancer, a Validation Observational Study.

The aim of this study is to assess the feasibility and the validity of the 2-minute walk test (2MWT) and the 10-meter walk test (10MeWT) compared to the 6-minute walk test (6MWT) for subjects with onco-hematological disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Cancer and its treatments have an impact on the body as a whole. The analysis of the subject's physical capacity is essential to know the basic level of the subject pre-treatment, to evaluate progress following rehabilitation, to set goals to prevent decline in physical capacity or to evaluate changes in physical capacity at different stages of survival. The 6-minute walk test (6MWT) is frequently used in the clinic to assess the physical capacity of the subject in oncology. A variant of the 6MWT exists and has been little studied in an oncological context: the 2-minute walk test (2MWT). The 2MWT is performed in the same way as the 6MWT: the same instructions and the same test procedure. It offers the advantage of being less tiring for the test subjects and saves clinicians time. The 2MWT has been validated in the past for people with COPD or after cardiac surgery. To our knowledge, it has not been validated for cancer patients.

The 10-meter walk test (10MeWT) is frequently used in practice to assess patients' functional capacity. It would be another way to assess the walking ability with a short test.

However, the relationship between the 2MWT, 6MWT and 10MeWT in an oncological context remain unclear.

Study Type

Observational

Enrollment (Actual)

56

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Geneva, Switzerland, 1205
        • Geneva University Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The study population will consist of 50 adults consulting at the University Hospitals for their oncological disease.

Description

Inclusion Criteria:

  • Have an onco-hematologic disease
  • Have medical authorization from the patient's oncologist authorizing gait tests
  • Participate in the HUG rehabilitation program
  • Be able to give consent by signature
  • To be of legal age
  • Do not present pain when walking more than 2/10
  • Be able to walk with or without technical aids for a period of 6 minutes (as per patient's statement)

Exclusion Criteria:

  • Suffer from heart problems
  • Bone metastases at risk of fracture
  • Osteoporosis at high risk of fracture
  • Unbalanced Hypertension (hypertension)
  • Not being able to carry out the walk tests in their entirety
  • Not being able to perform the gait tests for reasons related to the side effects of the treatments (anemia, undernutrition, vomiting, severe fatigue, risk of thrombocytopenia, pain).
  • Not being able to carry out the walking test because of a lack of understanding of the instructions or because of psychological problems.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cancer
Individuals with an oncology disease will be included in the study.
Diagnostic test: One leg stance test
The time held in unipodal equilibrium is measured by the examiner.
Diagnostic test: 6-minute walking test
The subject walks as far as possible for 6 minutes along a 30m long corridor.
Diagnostic test: 2-minute walking test
The subject walks as far as possible for 2 minutes along a 30m long corridor.
Diagnostic test: 10-meter walk test
The natural and fast walking speeds of the subject are measured over 10m. This speed is measured by the examiner as well as by the subject (self-tested version).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary endpoint: feasibility of the 2MWT and the 10MeWT
Time Frame: through study completion, an average of 1 year
The feasibility of the different tests will be assessed in an oncological setting.
through study completion, an average of 1 year
Primary endpoint: criterion validity with the 6MWT
Time Frame: through study completion, an average of 1 year
Criterion validity will be assessed by calculating the strength of the correlation between the 2MWT/10MeWT and the 6MWT.
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary endpoint: convergent construct validity
Time Frame: through study completion, an average of 1 year
Convergent construct validity will be evaluated by calculating the strength of the correlation between the 2MWT and the 10m walk test at comfortable/fast speed
through study completion, an average of 1 year
Secondary endpoint: criterion validity between 10m walk test and 10m walk test self-tested
Time Frame: through study completion, an average of 1 year
Criterion validity will be assessed by calculating the strength of the correlation between the 10m walk test self-tested and the 10m walk test timed by the examiner.
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aline Reinmann

Investigators

  • Principal Investigator: Aline Reinmann, School of Health Sciences Geneva

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2021

Primary Completion (Actual)

March 31, 2021

Study Completion (Actual)

March 31, 2021

Study Registration Dates

First Submitted

January 29, 2021

First Submitted That Met QC Criteria

February 7, 2021

First Posted (Actual)

February 11, 2021

Study Record Updates

Last Update Posted (Estimate)

January 4, 2023

Last Update Submitted That Met QC Criteria

December 30, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2020-00126

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

De-identified individual participant data for all primary and secondary outcomes will be made available.

IPD Sharing Time Frame

Data will be available within 6 months of study completion

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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