The primary objective of this 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…
ID
Source
Brief title
Condition
- Joint disorders
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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.
Secondary outcome
Aerobic capacity is determined by the VO2 at the VAT and the oxygen uptake
efficiency slope (OUES).
Background 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.
Study objective
The primary objective of this 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.
Study design
Cross-sectional feasibility study.
Study burden and risks
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 patients objectively
get insight in their preoperative aerobic capacity.
P. Debyelaan 25
Maastricht 6229 HX
NL
P. Debyelaan 25
Maastricht 6229 HX
NL
Listed location countries
Age
Inclusion criteria
* The patient is scheduled for primary unilateral TKA surgery in MUMC+ or St.
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 preparticipation
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCTID04773262 |
| CCMO | NL76561.068.21 |