Clinical trial NCT04750148: Validation of the Two-minute Walk Test and the Ten-meter Walk Test in Individuals With Cancer
Official title: Comparison of the 2MWT, the 10MeWT and the 6MWT in Individuals With Cancer, a Validation Observational Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Keywords: 6-minute walking test
2-minute walking test
10-meter walk test
Lead sponsor: School of Health Sciences Geneva
Sponsor class: OTHER
First posted: 2021-02-11
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will consist of 50 adults consulting at the University Hospitals for their oncological disease.

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Primary endpoint: feasibility of the 2MWT and the 10MeWT
timeFrame: through study completion, an average of 1 year
measure: Primary endpoint: criterion validity with the 6MWT
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Secondary endpoint: convergent construct validity
timeFrame: through study completion, an average of 1 year
measure: Secondary endpoint: criterion validity between 10m walk test and 10m walk test self-tested
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Geneva University Hospitals
Study officials:
affiliation: School of Health Sciences Geneva
name: Aline Reinmann
role: PRINCIPAL_INVESTIGATOR
References:
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