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Feasibility of CPET in Patients Prior to TKA

2022年1月17日更新者：Maastricht University Medical Center

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.

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.

調査の概要

状態

完了

条件

変形性関節症、膝

詳細な説明

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.

研究の種類

観察的

入学 (実際)

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

オランダ
- Limburg
  - Maastricht、Limburg、オランダ、6229
    - Maastricht UMC

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

サンプリング方法

非確率サンプル

調査対象母集団

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.

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

この研究は何を測定していますか？

主要な結果の測定

結果測定	メジャーの説明	時間枠
Feasibility of CPET 時間枠：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: 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.

二次結果の測定

結果測定	メジャーの説明	時間枠
Aerobic capacity: oxygen uptake (VO2) at the ventilatory anaerobic threshold (VAT), absolute value 時間枠：Immediately after CPET performance.	VO2 at the VAT in ml min-1.	Immediately after CPET performance.
Aerobic capacity: oxygen uptake (VO2) at the ventilatory anaerobic threshold (VAT), relative value 時間枠：Immediately after CPET performance.	VO2 at the VAT in ml kg-1 min-1.	Immediately after CPET performance.
Aerobic capacity: oxygen uptake efficiency slope (OUES), absolute value 時間枠：Immediately after CPET performance.	OUES; using all test data.	Immediately after CPET performance.
Aerobic capacity: oxygen uptake efficiency slope (OUES), normalised for body mass 時間枠：Immediately after CPET performance.	OUES.kg-1; using all test data.	Immediately after CPET performance.

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Maastricht University Medical Center

協力者

Anna Hospital

捜査官

主任研究者：A.F. Lenssen, prof. dr.、Department of physical therapy, Maastricht University Medical Center+ (MUMC+)

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2021年2月1日

一次修了 (実際)

2021年6月11日

研究の完了 (実際)

2021年6月11日

試験登録日

最初に提出

2021年1月29日

QC基準を満たした最初の提出物

2021年2月23日

最初の投稿 (実際)

2021年2月26日

学習記録の更新

投稿された最後の更新 (実際)

2022年2月1日

QC基準を満たした最後の更新が送信されました

2022年1月17日

最終確認日

2021年2月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

NL76561.068.21

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

IPD プランの説明

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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いいえ

米国FDA規制機器製品の研究

いいえ

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