The Inter and Intra Reliability of Cardiopulmonary Exercise Testing in Abdominal Aortic Aneurysm Patients

NCT02973308 | Completed

• 1 other identifier: 199037
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Exercise testing is commonly being used in patients before surgery to test their overall fitness. One group it is being used in is patients who have an enlarged blood vessel in their stomach. This is known as an abdominal aortic aneurysm. The exercise test used is known as a cardiopulmonary exercise test as it looks at both heart and lung function at the same time. Whilst this test is commonly used there have been no studies (to date) which have looked at how reliable this test is; this means how well the investigators can obtain the same (or very similar) results after multiple tests. The investigators would like to test this reliability both between patients and the clinicians performing the testing.

Conditions

Abdominal Aortic Aneurysm

Outcome Measures

Primary Outcomes (1)

• Anaerobic threshold

  The anaerobic threshold is a physiological measurement which is generated via breath by breath analysis and determined by the v-slope method as described in the summary.

  Up to One week

Secondary Outcomes (6)

• Minute ventilation

  Up to One week

• Respiratory exchange ratio

  Up to One week

• Total time of exercise

  Up to One week

• Quality of life Questionnaire

  Up to One week

• Time to anaerobic threshold

  Up to One week

Study Arms (4)

Treadmill-Test operator A

OTHER

Randomised to motorised treadmill group A for inter reliability, observer A will perform both exercise tests

Other: Observer

Treadmill-Test operator B

OTHER

Randomised to motorised treadmill group B for intra reliability, observer A will perform one exercise test, followed by observed B

Other: Observer

Cycle-Test operator A

OTHER

Randomised to cycle group B for inter reliability, observer A will perform both exercise tests

Other: Observer

Cycle-Test operator B

OTHER

Randomised to cycle group B for intra reliability, observer A will perform one exercise test, followed by observed B

Other: Observer

Interventions

Observer OTHER

Observer A and observer B

Cycle-Test operator A; Cycle-Test operator B; Treadmill-Test operator A; Treadmill-Test operator B

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be over the age of 45
• The patients must have the ability to walk unaided
• Must be considered for open or endovascular repair
• Have an AAA diameter of 5.4 cm or over.
• English speaking and able to follow simple protocol instructions

You may not qualify if:

• Active cancer treatment.
• Patients whom are not able to give informed consent
• Severe cardiovascular, musculo-skeletal or pulmonary illness precluding ability to partake in CPEX testing.

Sponsors & Collaborators

• Hull University Teaching Hospitals NHS Trust: lead
• University of Hull: collaborator

Study Sites (1)

Academic Vascular Surgery Unit, Vascular Laboratory, Alderson House, Hull Royal Infirmary

Hull, East Riding Of Yorkshire, HU3 2JZ, United Kingdom

Location

Related Publications (1)

• Harwood AE, Pymer S, Hitchman L, Totty J, Wallace T, Smith GE, Carradice D, Carroll S, Chetter IC. The Intrarater and Interrater Reliability of Measures Derived from Cardiopulmonary Exercise Testing in Patients with Abdominal Aortic Aneurysms. Ann Vasc Surg. 2019 Apr;56:175-182. doi: 10.1016/j.avsg.2018.08.087. Epub 2018 Nov 23.

  PMID: 30476603 RESULT

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Interventions

Observer Variation

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Errors; Diagnosis; Medical Errors; Health Services; Health Care Facilities Workforce and Services; Bias; Epidemiologic Factors; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Amy E Harwood, MSc

  AVSU Hull Royal Infirmary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2016
• First Posted: November 25, 2016
• Study Start: July 3, 2016
• Primary Completion: March 31, 2017
• Study Completion: June 14, 2017
• Last Updated: July 1, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)