Feasibility of CPET in Patients Prior to TKA

Osteoarthritis, Knee Clinical Trial

Official title:

Submaximal Cardiopulmonary Exercise Testing in Patients With Knee Osteoarthritis Scheduled for Total Knee Arthroplasty: a Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04773262
• Other study ID #: NL76561.068.21
• Status: Completed
• Start date: February 1, 2021
• Est. completion date: June 11, 2021

Study information

• Verified date: February 2021
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Higher aerobic capacity before surgery, as indicated during submaximal exercise testing by the oxygen uptake (VO2) at the ventilatory anaerobic threshold (VAT), is assumed to be prognostic for a better and faster postoperative recovery in patients with knee osteoarthritis (OA) undergoing total knee arthroplasty (TKA). Cardiopulmonary exercise testing (CPET) is the gold standard to measure aerobic capacity; however, it is unclear whether it is feasible to perform CPET using cycle ergometry in patients with knee OA prior to TKA surgery. The hypothesis is that performing CPET is feasible and participants will meet the feasibility criteria for success.

The primary objective of this cross-sectional feasibility study is to investigate the feasibility of CPET in patients with knee OA three to six weeks prior to TKA surgery in three domains: a) recruitment rate of participants who are representative of the target study population; b) reaching the VAT during CPET; and c) acceptability and suitability. The secondary objective is to investigate aerobic capacity of the study population and to compare values with normative values.

The study population consists of patients with knee OA scheduled for primary unilateral TKA surgery.

Feasibility of CPET will be assessed against five criteria: 1) recruitment rate ≥20%; 2) CPET performance rate ≥90%; 3) ≥90% of participants reached the VAT; 4) no serious adverse events; and 5) ≥80% of participants had a positive attitude towards CPET. Aerobic capacity is determined by the VO2 at the VAT and the oxygen uptake efficiency slope (OUES).

CPET is considered a safe procedure. Participants perform the CPET instead of a walking test following the standard preoperative screening and complete a questionnaire to examine their experiences. The investigator will contact the participants one week after the CPET to inquire whether they have developed any complaints afterwards. Benefit from participation is that all patients objectively get insight in their preoperative aerobic capacity.

Description:

It is unclear whether it is feasible to perform submaximal exercise testing using cycle ergometry to measure aerobic capacity in patients with knee osteoarthritis (OA) undergoing total knee arthroplasty (TKA). Individuals prior to TKA surgery experience increasing knee pain and are progressively restricted in their activities of daily living (ADL), sports and work, which negatively affect their aerobic capacity. This causes severe deconditioning, which is more prominent in patients with more severe knee OA. As part of usual care before TKA procedure, patients are screened for risk factors for delayed recovery by measuring physical functioning. Although various practical performance-based tests are performed, measuring aerobic capacity is included nowhere. Therefore, a walking test will be replaced by cardiopulmonary exercise testing (CPET) using cycle ergometry, which is the gold standard for measuring aerobic capacity.

A higher aerobic capacity prior to TKA surgery is assumed to be prognostic for a better and faster postoperative recovery. The first step is to explore whether it is feasible to perform a submaximal CPET prior to TKA surgery using cycle ergometry in patients with knee OA. When the feasibility criteria are met, the possible prognostic value of preoperative aerobic capacity on postoperative recovery can be investigated in a subsequent prospective cohort study.

Primary objective: to investigate the feasibility of submaximal CPET in patients with knee OA three to six weeks prior to TKA surgery in the MUMC+ and Anna Hospital regarding three domains: 1) recruitment rate of participants who are representative of the target study population; 2) feasibility of CPET procedure; and 3) acceptability and suitability of CPET. These domains are operationalized with five feasibility criteria.

Secondary objective: to explore the aerobic capacity of the study population, individuals with knee OA scheduled for TKA surgery, using submaximal parameters (VO2 at the VAT and OUES) and compare their aerobic capacity with normative values.

This cross-sectional study will be conducted at the Maastricht University Medical Center (MUMC+) and Anna Hospital. CPET will be performed three to six weeks before the TKA surgery following the preoperative screening. The study will include 15 to 20 participants.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: June 11, 2021
• Est. primary completion date: June 11, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Scheduled for primary unilateral TKA surgery in MUMC+ or Anna Hospital;

• Diagnosis of OA;

• CPET can be performed three to six weeks before TKA surgery following the preoperative screening;

• Mastery of the Dutch language.

Exclusion Criteria:

• Undergoing revision arthroplasty, bilateral TKA or hemi-arthroplasty surgery;

• Contraindications for CPET according to the American Thoracic Society (ATS) Statement on CPET and following the American Heart Association/American College of Sports Medicine (AHA/ACSM) Health/Fitness facility pre-participation screening questionnaire;

• Unable to get on and off a stationary bike;

• Complete dependence on a wheelchair;

• Serious comorbidities (e.g. malignancy, stroke);

• Cognitive impairments;

• Unable to sign informed consent.

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Locations

Country	Name	City	State
Netherlands	Maastricht UMC	Maastricht	Limburg

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University Medical Center	Anna Hospital

Country where clinical trial is conducted

Netherlands, 

References & Publications (5)

Orsmond GI, Cohn ES. The Distinctive Features of a Feasibility Study: Objectives and Guiding Questions. OTJR (Thorofare N J). 2015 Jul;35(3):169-77. — View Citation

Philbin EF, Groff GD, Ries MD, Miller TE. Cardiovascular fitness and health in patients with end-stage osteoarthritis. Arthritis Rheum. 1995 Jun;38(6):799-805. — View Citation

Philbin EF, Ries MD, French TS. Feasibility of maximal cardiopulmonary exercise testing in patients with end-stage arthritis of the hip and knee prior to total joint arthroplasty. Chest. 1995 Jul;108(1):174-81. — View Citation

Ries MD, Philbin EF, Groff GD, Sheesley KA, Richman JA, Lynch F Jr. Improvement in cardiovascular fitness after total knee arthroplasty. J Bone Joint Surg Am. 1996 Nov;78(11):1696-701. — View Citation

Ries MD, Philbin EF, Groff GD. Relationship between severity of gonarthrosis and cardiovascular fitness. Clin Orthop Relat Res. 1995 Apr;(313):169-76. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of CPET	Feasibility criteria: recruitment rate =20%: the percentage of eligible patients who gave informed consent to participate in the study; CPET performance rate =90%: the percentage of recruited participants actually performing CPET. They were able to pedal the bicycle around with 60 revolutions per minute (rpm) and cycling was not hindered by restricted knee flexion; =90% of participants reached the VAT (success rate): the percentage of participants who reached the VO2 at the VAT during CPET performance; 0% of participants experience serious adverse events during or after the test; and; =80% of participants had a positive attitude towards CPET: the percentage of participants who are willing to perform the exercise test again at a later moment.	Item 1 through study completion, an average of 9 months; items 2-4 immediately after CPET performance; and item 5 within one week after CPET performance.
Secondary	Aerobic capacity: oxygen uptake (VO2) at the ventilatory anaerobic threshold (VAT), absolute value	VO2 at the VAT in ml min-1.	Immediately after CPET performance.
Secondary	Aerobic capacity: oxygen uptake (VO2) at the ventilatory anaerobic threshold (VAT), relative value	VO2 at the VAT in ml kg-1 min-1.	Immediately after CPET performance.
Secondary	Aerobic capacity: oxygen uptake efficiency slope (OUES), absolute value	OUES; using all test data.	Immediately after CPET performance.
Secondary	Aerobic capacity: oxygen uptake efficiency slope (OUES), normalised for body mass	OUES.kg-1; using all test data.	Immediately after CPET performance.