Osteoarthritis, KneeNCT04773262
Feasibility of CPET in Patients Prior to TKA
An observational study of Osteoarthritis, Knee, run by Maastricht University Medical Center at 1 site in Netherlands.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- How many people
- 14 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Feb 2021to 11 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Submaximal Cardiopulmonary Exercise Testing in Patients With Knee Osteoarthritis Scheduled for Total Knee Arthroplasty: a Feasibility Study
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.
Read more
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.
Read the detailed 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.
- Conditions
- Osteoarthritis, Knee
- Keywords
- Osteoarthritis, Knee, Cardiopulmonary Exercise Testing, Feasibility
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
VO2 at the VAT in ml min-1.
Measured: Immediately after CPET performance.
Aerobic capacity: oxygen uptake (VO2) at the ventilatory anaerobic threshold (VAT), relative value
VO2 at the VAT in ml kg-1 min-1.
Measured: Immediately after CPET performance.
Aerobic capacity: oxygen uptake efficiency slope (OUES), absolute value
OUES; using all test data.
Measured: Immediately after CPET performance.
Aerobic capacity: oxygen uptake efficiency slope (OUES), normalised for body mass
OUES.kg-1; using all test data.
Measured: Immediately after CPET performance.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2021
- Study start1 Feb 2021
- Primary completion11 Jun 2021
- Study completion11 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Anna hospital
- Responsible party
- Sponsor
- Investigators
- A.F. Lenssen, prof. dr., Principal investigator, Department of physical therapy, Maastricht University Medical Center+ (MUMC+)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04773262
- Sponsor's protocol ID
- NL76561.068.21
- Status last verified
- Feb 2021
- First submitted
- 29 Jan 2021
- Last updated
- 1 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Once the feasibility study is published and the research team decide to proceed with a subsequent prospective cohort study to investigate the possible prognostic value of preoperative aerobic capacity on postoperative recovery, the data will not yet be accessible. However, data will be made available for inspection after completion of the study. For verification, data will be made available for people who have the necessary permissions/rights.
Publications
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.
PubMed 7606955Philbin 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.
PubMed 7779123Ries MD, Philbin EF, Groff GD. Relationship between severity of gonarthrosis and cardiovascular fitness. Clin Orthop Relat Res. 1995 Apr;(313):169-76.
PubMed 7641476Ries 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.
PubMed 8934484Orsmond 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.
PubMed 26594739
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Submaximal Cardiopulmonary Exercise Testing in Patients With Knee Osteoarthritis Scheduled for Total Knee Arthroplasty: a Feasibility Study
- ClinicalTrials.gov ID
- NCT04773262
- Acronym / sponsor ID
- NL76561.068.21
- Conditions
- Osteoarthritis, Knee
- Keywords
- Osteoarthritis, Knee, Cardiopulmonary Exercise Testing, Feasibility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Anna hospital
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 11 Jun 2021 (actual)
- Study completion
- 11 Jun 2021 (actual)
- First posted
- 26 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Feasibility of CPET
Time frame: 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.
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.
4 secondary outcomes
Aerobic capacity: oxygen uptake (VO2) at the ventilatory anaerobic threshold (VAT), absolute value
Time frame: Immediately after CPET performance.
Aerobic capacity: oxygen uptake (VO2) at the ventilatory anaerobic threshold (VAT), relative value
Time frame: Immediately after CPET performance.
Aerobic capacity: oxygen uptake efficiency slope (OUES), absolute value
Time frame: Immediately after CPET performance.
Aerobic capacity: oxygen uptake efficiency slope (OUES), normalised for body mass
Time frame: Immediately after CPET performance.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2022.
- Background: PubMed 7606955Philbin 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.
- Background: PubMed 7779123Philbin 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.
- Background: PubMed 7641476Ries MD, Philbin EF, Groff GD. Relationship between severity of gonarthrosis and cardiovascular fitness. Clin Orthop Relat Res. 1995 Apr;(313):169-76.
- Background: PubMed 8934484Ries 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.
- Background: PubMed 26594739Orsmond 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.
- Individual participant dataSharing planned: No. Once the feasibility study is published and the research team decide to proceed with a subsequent prospective cohort study to investigate the possible prognostic value of preoperative aerobic capacity on postoperative recovery, the data will not yet be accessible. However, data will be made available for inspection after completion of the study. For verification, data will be made available for people who have the necessary permissions/rights.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
A.F. Lenssen, prof. dr. principal investigator
Department of physical therapy, Maastricht University Medical Center+ (MUMC+)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, Knee, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of CPET (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04773262, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2022.