Can the 6MWT Can be Used to Identify Reduced Patient Fitness at Surgical Clinic

NCT04155151 | Completed

• 1 other identifier: STH21039
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Surgery

Outcome Measures

Primary Outcomes (3)

• 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

  Day 1

• Distance walked by the participants during the 6MWT measured in meters

  measured in meters completed

  Day 1

• The duration in time between the walk test and the participant attending for surgery

  measured in days

  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.

  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.

  for 90 days beyond the closure of the study

Study Arms (1)

Single Arm

EXPERIMENTAL

6 Minute Walking Test

Other: 6 minute walk test

Interventions

6 minute walk test OTHER

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.

Single Arm

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Considered for major abdominal surgery who can weight bear

You may not qualify if:

• Considered for major surgery who cannot weight bear
• Unable to follow the verbal instructions on walking test procedure provided by the researcher

Sponsors & Collaborators

• Sheffield Teaching Hospitals NHS Foundation Trust: lead

Study Sites (1)

Northern General Hospital

Sheffield, South Yorks, S5 7AU, United Kingdom

Location

Study Officials

• Angela Pinder

  Sheffield Teaching Hospitals NHS Foundation Trust

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective observational

Study Record Dates

• First Submitted: October 29, 2019
• First Posted: November 7, 2019
• Study Start: February 8, 2021
• Primary Completion: March 8, 2022
• Study Completion: May 4, 2022
• Last Updated: May 10, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)