SurgeryNCT04155151
Can the 6MWT Can be Used to Identify Reduced Patient Fitness at Surgical Clinic
A study testing 6 minute walk test in people with Surgery, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The aim of this study is to assess the feasibility of using the 6 minute walk test (6MWT) as a cardiorespiratory fitness (CRF) screening tool. The screening would take place when the patient attends the hospital for their initial surgical outpatient appointment. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Surgery
- What is being tested?
- 6 minute walk test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 8 Feb 2021to 4 May 2022
- Phase
- Interventional
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Considered for major abdominal surgery who can weight bear
Who cannot join
- Considered for major surgery who cannot weight bear
- Unable to follow the verbal instructions on walking test procedure provided by the researcher
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Northern General Hospital
Sheffield, South Yorks, S5 7AU
About this study
Official title: Feasibility Study to Assess if Using the 6 Minute Walk Test at a Patients First Visit to Surgical Outpatients Will Identify Those Individuals With a Significantly Reduced Level of Cardiorespiratory Fitness.
The aim of this study is to assess the feasibility of using the 6 minute walk test (6MWT) as a cardiorespiratory fitness (CRF) screening tool. The screening would take place when the patient attends the hospital for their initial surgical outpatient appointment. By screening all potential major intra-abdominal surgery patients for a period of 6 months and recording the distance walked in the 6 minutes (6MWD) the aim is to produce a threshold distance for the patients of Sheffield that would identify those with sufficient CRF what would allow them to proceed to surgery without further investigations or fitness interventions.
Having identified the fit it would allow the perioperative team to focus resources on the less fit with the aim of improving CRF and other elements that would lead to reduced postoperative morbidity and mortality.
Read more
Other primary aims include noting the time to surgery. This data will inform on wither instigation of the early screening test would facilitate enrolment and completion of an exercise programme before surgery.
The secondary aim is to assess the relationship between the 6MWD and routine CPET to confirm if those that walk the furthest are in fact the fittest.
Read the detailed description
This is a prospective observational study that would run for a period of 6 months. The population proceeding to undergo major abdominal surgery is estimated to be 500 patients a year. The primary aim is to invite all patients being considered for major abdominal surgery to participate in a simple screening test of fitness, the 6 minute walk test (6MWT).
Potential participants would be identified by the participating surgical teams during their first visit to this institutions Surgical Outpatient Department (SOPD). Upon identification the individual would be provided with information designed to be read on returning to the waiting area from the SOPD clinic room.
The study walker, who would be an appropriately trained research nurse or outpatient clinic support worker, would approach the patient to answer questions and provide further information if required. Consent for participation would then be obtained. The participating individual would then be walked the short distance to the testing area and would be offered a seat whilst the 6MWT procedure was explained in more detail. Time would be allowed for questions. The 6MWT would be then conducted as per the American Thoracic Society guidance. Heart rate will be recorded manually both at baseline and at the cessation of the test.
Following the 6MWT patients could either depart the hospital or return to the SOPD if it was felt a period of recovery was required.
The 6 minute walk distance (6MWD) would be recorded against the patient's participant study identification number. Patient identifiers that would link the patient study number to a particular patient would be stored safely behind lock and key or encryption when electronic. The case report forms will be paper to allow timely collection of data and this information will be collated onto a spreadsheet which will facilitate future analysis.
At a later date information will also be collected on date of operation, this will be used to assess the present 'window' of opportunity for enrolling the less fit into an exercise programme.
A secondary aim of this study is to investigate the relationship between the 6MWD and the objectively measured anaerobic threshold and peak oxygen consumption that will be obtained when some of these patients undergo cardiopulmonary exercise testing (CPET) as part of their standard pathway to surgery. Reports produced following CPET interpretation are stored as PDFs upon this institutions server, named individuals involved in collecting data for this study will have access to the this server to complete case report forms that require details from the CPET reports.
Statistical analysis:
Descriptive statistics will be undertaken on the population that participates in the 6MWT, the population will be split into quartiles based on what the investigators know about our non-cardiopulmonary surgery population following analysis of our CPET database. Those deemed significantly less fit occupied the lowest quartile. The aim would be to assess for population normality and produce thresholds for the most fit; the greatest distance walked by 25% of the population with the least fit the lowest 25% of the population. The middle 50% would be less fit.
Linear regression analysis will be used to determine the 6MWD threshold that correlates with a level of anaerobic threshold or peak oxygen consumption objectively measured by CPET, deemed acceptable and indicating those individuals for whom no further preoperative interventions are required.
During the 12 months of 2017 the investigators undertook 483 preoperative major abdominal surgery cardiopulmonary exercise (CPET) tests. The investigators anticipate collecting 6MWT data on 250 patients and CPET data on at least 240 patients. Hopefully all those who undergo CPET will have consented to undergo a 6MWT whilst in the SOPD during their first visit on their pathway toward surgery.
- Conditions
- Surgery
- Being tested
- 6 minute walk test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6 minute walk testOther
A test of fitness that requests the participant to walk as far as they can at their own pace in 6 minutes, the distance walked in those 6 minutes is recorded.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | 6 Minute Walking Test Receives: Other: 6 minute walk test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Can all the patients invited to 6MWT complete the walk test
Number of participants who are able to complete the walk test at their first visit
Measured: Day 1
Distance walked by the participants during the 6MWT measured in meters
measured in meters completed
Measured: Day 1
The duration in time between the walk test and the participant attending for surgery
measured in days
Measured: within 60 days of original single point measurement
Secondary outcomes (2)
Correlation between the distance walked during the 6 minute walk test and anaerobic threshold as measured by cardiopulmonary exercise testing (CPET) in ml/kg/min.
statistical analysis
Measured: for 90 days beyond the closure of the study
Correlation between the distance walked during the 6 minute walk test and peak oxygen consumption as measured by cardiopulmonary exercise testing (CPET) in ml/kg/min.
statistical analysis
Measured: for 90 days beyond the closure of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2019
- Study start8 Feb 2021
- Primary completion8 Mar 2022
- Study completion4 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective observational
- Masking
- None (open label)
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Angela Pinder, Study chair, Sheffield Teaching Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04155151
- Sponsor's protocol ID
- STH21039
- Status last verified
- May 2022
- First submitted
- 29 Oct 2019
- Last updated
- 10 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study to Assess if Using the 6 Minute Walk Test at a Patients First Visit to Surgical Outpatients Will Identify Those Individuals With a Significantly Reduced Level of Cardiorespiratory Fitness.
- ClinicalTrials.gov ID
- NCT04155151
- Acronym / sponsor ID
- STH21039
- Conditions
- Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- 8 Feb 2021 (actual)
- Primary completion
- 8 Mar 2022 (actual)
- Study completion
- 4 May 2022 (actual)
- First posted
- 7 Nov 2019 (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 of using the 6 minute walk test (6MWT) as a cardiorespiratory fitness (CRF) screening tool. The screening would take place when the patient attends the hospital for their initial surgical outpatient appointment. By screening all potential major intra-abdominal surgery patients for a period of 6 months and recording the distance walked in the 6 minutes (6MWD) the aim is to produce a threshold distance for the patients of Sheffield that would identify those with sufficient CRF what would allow them to proceed to surgery without further investigations or fitness interventions.
Having identified the fit it would allow the perioperative team to focus resources on the less fit with the aim of improving CRF and other elements that would lead to reduced postoperative morbidity and mortality.
Other primary aims include noting the time to surgery. This data will inform on wither instigation of the early screening test would facilitate enrolment and completion of an exercise programme before surgery.
The secondary aim is to assess the relationship between the 6MWD and routine CPET to confirm if those that walk the furthest are in fact the fittest.
Detailed description
This is a prospective observational study that would run for a period of 6 months. The population proceeding to undergo major abdominal surgery is estimated to be 500 patients a year. The primary aim is to invite all patients being considered for major abdominal surgery to participate in a simple screening test of fitness, the 6 minute walk test (6MWT).
Potential participants would be identified by the participating surgical teams during their first visit to this institutions Surgical Outpatient Department (SOPD). Upon identification the individual would be provided with information designed to be read on returning to the waiting area from the SOPD clinic room.
The study walker, who would be an appropriately trained research nurse or outpatient clinic support worker, would approach the patient to answer questions and provide further information if required. Consent for participation would then be obtained. The participating individual would then be walked the short distance to the testing area and would be offered a seat whilst the 6MWT procedure was explained in more detail. Time would be allowed for questions. The 6MWT would be then conducted as per the American Thoracic Society guidance. Heart rate will be recorded manually both at baseline and at the cessation of the test.
Following the 6MWT patients could either depart the hospital or return to the SOPD if it was felt a period of recovery was required.
The 6 minute walk distance (6MWD) would be recorded against the patient's participant study identification number. Patient identifiers that would link the patient study number to a particular patient would be stored safely behind lock and key or encryption when electronic. The case report forms will be paper to allow timely collection of data and this information will be collated onto a spreadsheet which will facilitate future analysis.
At a later date information will also be collected on date of operation, this will be used to assess the present 'window' of opportunity for enrolling the less fit into an exercise programme.
A secondary aim of this study is to investigate the relationship between the 6MWD and the objectively measured anaerobic threshold and peak oxygen consumption that will be obtained when some of these patients undergo cardiopulmonary exercise testing (CPET) as part of their standard pathway to surgery. Reports produced following CPET interpretation are stored as PDFs upon this institutions server, named individuals involved in collecting data for this study will have access to the this server to complete case report forms that require details from the CPET reports.
Statistical analysis:
Descriptive statistics will be undertaken on the population that participates in the 6MWT, the population will be split into quartiles based on what the investigators know about our non-cardiopulmonary surgery population following analysis of our CPET database. Those deemed significantly less fit occupied the lowest quartile. The aim would be to assess for population normality and produce thresholds for the most fit; the greatest distance walked by 25% of the population with the least fit the lowest 25% of the population. The middle 50% would be less fit.
Linear regression analysis will be used to determine the 6MWD threshold that correlates with a level of anaerobic threshold or peak oxygen consumption objectively measured by CPET, deemed acceptable and indicating those individuals for whom no further preoperative interventions are required.
During the 12 months of 2017 the investigators undertook 483 preoperative major abdominal surgery cardiopulmonary exercise (CPET) tests. The investigators anticipate collecting 6MWT data on 250 patients and CPET data on at least 240 patients. Hopefully all those who undergo CPET will have consented to undergo a 6MWT whilst in the SOPD during their first visit on their pathway toward surgery.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective observational
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Other: 6 minute walk test6 Minute Walking Test |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Considered for major abdominal surgery who can weight bear
Key exclusion criteria (2 listed)
- Considered for major surgery who cannot weight bear
- Unable to follow the verbal instructions on walking test procedure provided by the researcher
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 walk testA test of fitness that requests the participant to walk as far as they can at their own pace in 6 minutes, the distance walked in those 6 minutes is recorded. | Other | Single Arm |
Primary outcome
Can all the patients invited to 6MWT complete the walk test
Time frame: Day 1
Number of participants who are able to complete the walk test at their first visit
Distance walked by the participants during the 6MWT measured in meters
Time frame: Day 1
measured in meters completed
The duration in time between the walk test and the participant attending for surgery
Time frame: within 60 days of original single point measurement
measured in days
2 secondary outcomes
Correlation between the distance walked during the 6 minute walk test and anaerobic threshold as measured by cardiopulmonary exercise testing (CPET) in ml/kg/min.
Time frame: for 90 days beyond the closure of the study
Correlation between the distance walked during the 6 minute walk test and peak oxygen consumption as measured by cardiopulmonary exercise testing (CPET) in ml/kg/min.
Time frame: for 90 days beyond the closure of the study
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 10 May 2022.
- Individual participant dataSharing planned: No
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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.
Angela Pinder study chair
Sheffield Teaching Hospitals NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 6 minute walk test in people with Surgery, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
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 1 inclusion and 2 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 10 May 2022. 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 United Kingdom. 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?
Can all the patients invited to 6MWT complete the walk test (time frame: Day 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 May 2022.