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

Cancer Clinical Trial

— 2MWTOnco  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04750148
• Other study ID #: 2020-00126
• Status: Completed
• Start date: February 15, 2021
• Est. completion date: March 31, 2021

Study information

• Verified date: December 2022
• Source: School of Health Sciences Geneva
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: March 31, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer

Intervention

Diagnostic Test:
• 6-minute walking test
The subject walks as far as possible for 6 minutes along a 30m long corridor.
• 2-minute walking test
The subject walks as far as possible for 2 minutes along a 30m long corridor.
• 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).
• One leg stance test
The time held in unipodal equilibrium is measured by the examiner.

Locations

Country	Name	City	State
Switzerland	Geneva University Hospitals	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
Aline Reinmann

Country where clinical trial is conducted

Switzerland, 

References & Publications (10)

Bohannon RW, Bubela D, Magasi S, McCreath H, Wang YC, Reuben D, Rymer WZ, Gershon R. Comparison of walking performance over the first 2 minutes and the full 6 minutes of the Six-Minute Walk Test. BMC Res Notes. 2014 Apr 25;7:269. doi: 10.1186/1756-0500-7-269. — View Citation

Butland RJ, Pang J, Gross ER, Woodcock AA, Geddes DM. Two-, six-, and 12-minute walking tests in respiratory disease. Br Med J (Clin Res Ed). 1982 May 29;284(6329):1607-8. doi: 10.1136/bmj.284.6329.1607. No abstract available. — View Citation

Chan WLS, Pin TW. Reliability, validity and minimal detectable change of 2-minute walk test, 6-minute walk test and 10-meter walk test in frail older adults with dementia. Exp Gerontol. 2019 Jan;115:9-18. doi: 10.1016/j.exger.2018.11.001. Epub 2018 Nov 10. — View Citation

Eden MM, Tompkins J, Verheijde JL. Reliability and a correlational analysis of the 6MWT, ten-meter walk test, thirty second sit to stand, and the linear analog scale of function in patients with head and neck cancer. Physiother Theory Pract. 2018 Mar;34(3):202-211. doi: 10.1080/09593985.2017.1390803. Epub 2017 Oct 25. — View Citation

Gijbels D, Eijnde BO, Feys P. Comparison of the 2- and 6-minute walk test in multiple sclerosis. Mult Scler. 2011 Oct;17(10):1269-72. doi: 10.1177/1352458511408475. Epub 2011 Jun 3. — View Citation

Kosak M, Smith T. Comparison of the 2-, 6-, and 12-minute walk tests in patients with stroke. J Rehabil Res Dev. 2005 Jan-Feb;42(1):103-7. doi: 10.1682/jrrd.2003.11.0171. — View Citation

Leung AS, Chan KK, Sykes K, Chan KS. Reliability, validity, and responsiveness of a 2-min walk test to assess exercise capacity of COPD patients. Chest. 2006 Jul;130(1):119-25. doi: 10.1378/chest.130.1.119. — View Citation

Reid L, Thomson P, Besemann M, Dudek N. Going places: Does the two-minute walk test predict the six-minute walk test in lower extremity amputees? J Rehabil Med. 2015 Mar;47(3):256-61. doi: 10.2340/16501977-1916. — View Citation

Scalzitti DA, Harwood KJ, Maring JR, Leach SJ, Ruckert EA, Costello E. Validation of the 2-Minute Walk Test with the 6-Minute Walk Test and Other Functional Measures in Persons with Multiple Sclerosis. Int J MS Care. 2018 Jul-Aug;20(4):158-163. doi: 10.7224/1537-2073.2017-046. — View Citation

Schmidt K, Vogt L, Thiel C, Jager E, Banzer W. Validity of the six-minute walk test in cancer patients. Int J Sports Med. 2013 Jul;34(7):631-6. doi: 10.1055/s-0032-1323746. Epub 2013 Feb 26. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary endpoint: feasibility of the 2MWT and the 10MeWT	The feasibility of the different tests will be assessed in an oncological setting.	through study completion, an average of 1 year
Primary	Primary endpoint: criterion validity with the 6MWT	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	Secondary endpoint: convergent construct validity	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	Secondary endpoint: criterion validity between 10m walk test and 10m walk test self-tested	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