Feasibility of CPET in Patients Prior to TKA

NCT04773262 | Completed DMC

• 1 other identifier: NL76561.068.21
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Osteoarthritis, Knee

Keywords

Osteoarthritis; Knee; Cardiopulmonary Exercise Testing; Feasibility

Outcome Measures

Primary Outcomes (1)

• Feasibility of CPET

  Feasibility criteria: 1. recruitment rate ≥20%: the percentage of eligible patients who gave informed consent to participate in the study; 2. 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; 3. ≥90% of participants reached the VAT (success rate): the percentage of participants who reached the VO2 at the VAT during CPET performance; 4. 0% of participants experience serious adverse events during or after the test; and 5. ≥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 Outcomes (4)

• Aerobic capacity: oxygen uptake (VO2) at the ventilatory anaerobic threshold (VAT), absolute value

  Immediately after CPET performance.

• Aerobic capacity: oxygen uptake (VO2) at the ventilatory anaerobic threshold (VAT), relative value

  Immediately after CPET performance.

• Aerobic capacity: oxygen uptake efficiency slope (OUES), absolute value

  Immediately after CPET performance.

• Aerobic capacity: oxygen uptake efficiency slope (OUES), normalised for body mass

  Immediately after CPET performance.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be included from the preoperative assessment clinic for TKA at the department of Physical Therapy at the MUMC+ and Anna Hospital with a diagnosis of symptomatic end-stage OA of the knee. It was decided to undergo an unilateral primary TKA surgery, because of failing of conservative treatment(s) and/or worsening of knee complaints.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• Anna hospital: collaborator

Study Sites (1)

Maastricht UMC

Maastricht, Limburg, 6229, Netherlands

Location

Related Publications (5)

• 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. doi: 10.1378/chest.108.1.174.

  PMID: 7606955 BACKGROUND

• 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. doi: 10.1002/art.1780380613.

  PMID: 7779123 BACKGROUND

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

  PMID: 7641476 BACKGROUND

• 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. doi: 10.2106/00004623-199611000-00009.

  PMID: 8934484 BACKGROUND

• 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. doi: 10.1177/1539449215578649.

  PMID: 26594739 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• A.F. Lenssen, prof. dr.

  Department of physical therapy, Maastricht University Medical Center+ (MUMC+)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2021
• First Posted: February 26, 2021
• Study Start: February 1, 2021
• Primary Completion: June 11, 2021
• Study Completion: June 11, 2021
• Last Updated: February 1, 2022

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)