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NCT Number: NCT04750148

Validation of the Two-minute Walk Test and the Ten-meter Walk Test in Individuals With Cancer

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.

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Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Geneva University Hospitals

Geneva, 1205, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

6-minute walking test

Diagnostic Test

The subject walks as far as possible for 6 minutes along a 30m long corridor.

2-minute walking test

Diagnostic Test

The subject walks as far as possible for 2 minutes along a 30m long corridor.

10-meter walk test

Diagnostic 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).

One leg stance test

Diagnostic Test

The time held in unipodal equilibrium is measured by the examiner.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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

  2. 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.

Sponsors and collaborators

Lead sponsor

Aline Reinmann

Other

Registry information

Official study title

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

Acronym: 2MWTOnco

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 11, 2021
Registry last updated
Jan 4, 2023

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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