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

Completed

• Conditions: Cancer
• Interventions: Diagnostic Test: 6-minute walking test; Diagnostic Test: 2-minute walking test; Diagnostic Test: 10-meter walk test; Diagnostic Test: One leg stance test

• Registration Number: NCT04750148
• Lead Sponsor: Aline Reinmann

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.

Study Timeline

• Study First Submitted: 2021-01-29
• Study First Submitted QC: 2021-02-07
• Study First Posted: 2021-02-11
• Study Start: 2021-02-15
• Primary Completion: 2021-03-31
• Study Completion: 2021-03-31
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-30
• Last Update Posted: 2023-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cancer	2-minute walking test	Individuals with an oncology disease will be included in the study.
Cancer	6-minute walking test	Individuals with an oncology disease will be included in the study.
Cancer	One leg stance test	Individuals with an oncology disease will be included in the study.
Cancer	10-meter walk test	Individuals with an oncology disease will be included in the study.

Primary Outcome Measures

Name	Time	Method
Primary endpoint: feasibility of the 2MWT and the 10MeWT	through study completion, an average of 1 year	The feasibility of the different tests will be assessed in an oncological setting.
Primary endpoint: criterion validity with the 6MWT	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 Outcome Measures

Name	Time	Method
Secondary endpoint: convergent construct validity	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
Secondary endpoint: criterion validity between 10m walk test and 10m walk test self-tested	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.

Trial Locations

Locations (1)

Geneva University Hospitals; 🇨🇭 Geneva, Switzerland