Cancer2MWTOncoNCT04750148
Validation of the Two-minute Walk Test and the Ten-meter Walk Test in Individuals With Cancer
An observational study of Cancer, run by Aline Reinmann at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- 6-minute walking test, 2-minute walking test and 10-meter walk test
- How many people
- 56 participants
- Where
- 1 siteSwitzerland
- Study dates
- 15 Feb 2021to 31 Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of 50 adults consulting at the University Hospitals for their oncological disease.
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the 2MWT, the 10MeWT and the 6MWT in Individuals With Cancer, a Validation Observational Study.
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.
Read the 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.
- Conditions
- Cancer
- Being tested
- 6-minute walking test, 2-minute walking test, 10-meter walk test, One leg stance test
- Keywords
- 6-minute walking test, 2-minute walking test, 10-meter walk test
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6-minute walking testDiagnostic test
The subject walks as far as possible for 6 minutes along a 30m long corridor.
2-minute walking testDiagnostic test
The subject walks as far as possible for 2 minutes along a 30m long corridor.
10-meter walk testDiagnostic 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 testDiagnostic test
The time held in unipodal equilibrium is measured by the examiner.
| Study group | Role | What they receive |
|---|---|---|
| Cancer | Individuals with an oncology disease will be included in the study. Receives: Diagnostic Test: 6-minute walking test; Diagnostic Test: 2-minute walking test; Diagnostic Test: 10-meter walk test; Diagnostic Test: One leg stance test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary endpoint: feasibility of the 2MWT and the 10MeWT
The feasibility of the different tests will be assessed in an oncological setting.
Measured: 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.
Measured: through study completion, an average of 1 year
Secondary outcomes (2)
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
Measured: through study completion, an average of 1 year
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.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2021
- Study start15 Feb 2021
- Primary completion31 Mar 2021
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aline Reinmann
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Aline Reinmann, School of Health Sciences Geneva
- Investigators
- Aline Reinmann, Principal investigator, School of Health Sciences Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04750148
- Sponsor's protocol ID
- 2020-00126
- Acronym
- 2MWTOnco
- Status last verified
- Dec 2022
- First submitted
- 29 Jan 2021
- Last updated
- 4 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data for all primary and secondary outcomes will be made available.
Publications
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.
PubMed 24767634Butland 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.
PubMed 6805625Chan 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.
PubMed 30423359Eden 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.
PubMed 29068767Gijbels 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.
PubMed 21642370Kosak 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.
PubMed 15742254Leung 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.
PubMed 16840391Reid 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.
PubMed 25588644Scalzitti 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.
PubMed 30150899Schmidt 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.
PubMed 23444095
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the 2MWT, the 10MeWT and the 6MWT in Individuals With Cancer, a Validation Observational Study.
- ClinicalTrials.gov ID
- NCT04750148
- Acronym / sponsor ID
- 2MWTOnco / 2020-00126
- Conditions
- Cancer
- Keywords
- 6-minute walking test, 2-minute walking test, 10-meter walk test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Aline ReinmannUniversity, hospital or other
- Study start
- 15 Feb 2021 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 11 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cancer | – | Diagnostic Test: 6-minute walking test, Diagnostic Test: 2-minute walking test, Diagnostic Test: 10-meter walk test, Diagnostic Test: One leg stance testIndividuals with an oncology disease will be included in the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of 50 adults consulting at the University Hospitals for their oncological disease.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 6-minute walking testThe subject walks as far as possible for 6 minutes along a 30m long corridor. | Diagnostic test | Cancer |
| 2-minute walking testThe subject walks as far as possible for 2 minutes along a 30m long corridor. | Diagnostic test | Cancer |
| 10-meter walk testThe 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 | Cancer |
| One leg stance testThe time held in unipodal equilibrium is measured by the examiner. | Diagnostic test | Cancer |
Primary outcome
Primary endpoint: feasibility of the 2MWT and the 10MeWT
Time frame: 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
Time frame: 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.
2 secondary outcomes
Secondary endpoint: convergent construct validity
Time frame: through study completion, an average of 1 year
Secondary endpoint: criterion validity between 10m walk test and 10m walk test self-tested
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2023.
- Background: PubMed 24767634Bohannon 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.
- Background: PubMed 6805625Butland 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.
- Background: PubMed 30423359Chan 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.
- Background: PubMed 29068767Eden 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.
- Background: PubMed 21642370Gijbels 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.
- Background: PubMed 15742254Kosak 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.
- Background: PubMed 16840391Leung 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.
- Background: PubMed 25588644Reid 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.
- Background: PubMed 30150899Scalzitti 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.
- Background: PubMed 23444095Schmidt 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.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary and secondary outcomes will be made available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aline Reinmann principal investigator
School of Health Sciences Geneva
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Aline Reinmann at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary endpoint: feasibility of the 2MWT and the 10MeWT (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04750148, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2023.