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

NCT04750148 | Completed

• 1 other identifier: 2020-00126
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

6-minute walking test; 2-minute walking test; 10-meter walk test

Outcome Measures

Primary Outcomes (2)

• 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 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 Outcomes (2)

• Secondary endpoint: convergent construct validity

  through study completion, an average of 1 year

• Secondary endpoint: criterion validity between 10m walk test and 10m walk test self-tested

  through study completion, an average of 1 year

Study Arms (1)

Cancer

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

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

Interventions

6-minute walking test DIAGNOSTIC_TEST

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

Cancer

2-minute walking test DIAGNOSTIC_TEST

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

Cancer

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).

Cancer

One leg stance test DIAGNOSTIC_TEST

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

Cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population will consist of 50 adults consulting at the University Hospitals for their oncological disease.

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aline Reinmann: lead

Study Sites (1)

Geneva University Hospitals

Geneva, 1205, Switzerland

Location

Related 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.

  PMID: 24767634 BACKGROUND

• 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.

  PMID: 6805625 BACKGROUND

• 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.

  PMID: 30423359 BACKGROUND

• 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.

  PMID: 29068767 BACKGROUND

• 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.

  PMID: 21642370 BACKGROUND

• 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.

  PMID: 15742254 BACKGROUND

• 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.

  PMID: 16840391 BACKGROUND

• 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.

  PMID: 25588644 BACKGROUND

• 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.

  PMID: 30150899 BACKGROUND

• 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.

  PMID: 23444095 BACKGROUND

MeSH Terms

Conditions

Neoplasms

Study Officials

• Aline Reinmann

  School of Health Sciences Geneva

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 29, 2021
• First Posted: February 11, 2021
• Study Start: February 15, 2021
• Primary Completion: March 31, 2021
• Study Completion: March 31, 2021
• Last Updated: January 4, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be available within 6 months of study completion

Locations

CH (1)