2MWTOnco: Validation of the Two-minute Walk Test in an Oncology Setting

Sponsor
Aline Reinmann (Other)
Overall Status
Completed
CT.gov ID
NCT04750148
Collaborator
(none)
56
1
1.4
38.7

Study Details

Study Description

Brief Summary

The aim of this study is to assess the validity of the 2-minute walk test (2MWT) compared to the 6-minute walk test (TM6) for subjects with onco-hematological disease.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: 6-minute walk test
  • Diagnostic Test: 2-minutes walk test
  • Diagnostic Test: 10-meters walk test
  • Diagnostic Test: One leg stance test

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.

Study Design

Study Type:
Observational
Actual Enrollment :
56 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Assessment of Physical Ability in Oncology: a Validation Study of the Two-minute Walk Test
Actual Study Start Date :
Feb 15, 2021
Actual Primary Completion Date :
Mar 31, 2021
Actual Study Completion Date :
Mar 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Cancer

Individuals with an oncology disease will be included in the study.

Diagnostic Test: 6-minute walk test
The subject walks as far as possible for 6 minutes along a 30m long corridor.

Diagnostic Test: 2-minutes walk test
The subject walks as far as possible for 2 minutes along a 30m long corridor.

Diagnostic Test: 10-meters 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).

Diagnostic Test: One leg stance test
The time held in unipodal equilibrium is measured by the examiner.

Outcome Measures

Primary Outcome Measures

  1. Primary endpoint: criterion validity with 6MWT [One year and through study completion]

    Criterion validity will be assessed by calculating the strength of the correlation between 2MWT and 6MWT.

Secondary Outcome Measures

  1. Secondary endpoint: convergent construct validity [One year and through study completion]

    Convergent construct validity will be evaluated by calculating the strength of the correlation between the 2MWT and the 10m walk test at spontaneous/fast speed as well as with the unipodal equilibrium test.

  2. Secondary endpoint: criterion validity between 10m walk test and 10m walk test self-tested [One year and through study completion]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Geneva University Hospitals Geneva Switzerland 1205

Sponsors and Collaborators

  • Aline Reinmann

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Aline Reinmann, Principal Investigator, School of Health Sciences Geneva
ClinicalTrials.gov Identifier:
NCT04750148
Other Study ID Numbers:
  • 2020-00126
First Posted:
Feb 11, 2021
Last Update Posted:
Jul 7, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Aline Reinmann, Principal Investigator, School of Health Sciences Geneva

Study Results

No Results Posted as of Jul 7, 2021