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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in United Kingdom

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 groups in NCT04155151
Study groupRoleWhat they receive
Single ArmExperimental6 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.

  1. 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

  2. Distance walked by the participants during the 6MWT measured in meters

    measured in meters completed

    Measured: Day 1

  3. 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)
  1. 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

  2. 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.

  1. First posted7 Nov 2019
  2. Study start8 Feb 2021
  3. Primary completion8 Mar 2022
  4. Study completion4 May 2022

Resources

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)
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

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.

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