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临床试验/NCT02265523
NCT02265523已完成不适用

The Effects of Exercise and Cycle Ergometry in Post-Operative Total Knee Patients-A Randomized Controlled Trial

Lakehead University2 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2016年1月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
55
试验地点
2
主要终点
Knee pain/functional status/swelling/ROM/strength

研究概览

简要总结

The purpose of this investigation is to examine the effect of, and improve patient compliance and motivation following total knee arthroplasty; to determine the efficacy of two post-surgical exercise programs on knee pain, function, range of motion, strength, and swelling (girth); and to establish a panel of biomarkers that will allow: a) early identification of patients at risk (i.e. unable to complete post-operative treatment) and; b) predict the likelihood of a successful treatment outcome post-surgically.

详细描述

Participants will be recruited from the current waiting list at either Thunder Bay Regional Health Sciences Centre or Big Thunder Orthopedics. The physician will be discussing the study and eligibility requirements with the potential participants. The research assistant at Big Thunder will then obtain signed consent from the potential participant during the pre-operative appointment. If the potential participant would like to discuss the study with the research team as well as the doctor before giving consent, the research team will be contacted. Adequate enrolment is expected as the amount of TKA performed in previous years has been above 300.

Eligibility screening will be performed by the physician in the surgeon's office prior to the potential participant giving informed consent. The physician will make the decision of whether or not someone is eligible based on examination of their medical history. If the potential participant is ineligible based on this information, they will not be involved in the study.

During a consultation, the physician will familiarize the potential participant with the study, the consent form, and any other relevant study material. The physician will answer any questions the potential participant has about the study and ask if they would rather speak with a member of the research team. The potential participant will be given the opportunity to discuss the study with an investigator and the Research Ethics Board prior to signing the consent form. If the participant wishes to consent to the study they will speak with the research assistant from Big Thunder at the pre-operative appointment who will obtain their signed consent form. The participant will be given a copy of the signed consent form and information letter for their records. The original form will be temporarily stored in a locked cabinet at Big Thunder, and picked up weekly to be retained by Dr. Paolo Sanzo in his locked office.

The two study groups will be the standard post-operative exercise protocol or the exercise protocol combined with the use of the Viscus V1.5 kinetic flywheel ergometer. The standard post-operative exercises are already currently recommended to patients. Briefly, they include deep breathing and coughing, ankle pumping, buttock contractions, and static quadriceps strengthening. The use of the kinetic flywheel ergometer will allow for pedal revolutions to be tracked as well as time of use. Participants randomized into the Viscus group will have access to a Viscus V1.5 24 hours per day in their recovery room to use at their leisure. All participants will track their own exercise in the exercise log which will be used to observe compliance. The participant's intensity of exercise will be rated on a 5-point Likert scale by the treating physiotherapist/nurse using the Sports Injury Rehabilitation Adherence Scale (SIRAS). The intensity of exercise will be rated from minimum effort to maximum effort; the frequency of exercise and the participants ability to follow instructions and advice will be rated from never to always; and the receptivity to changes in program will be rated from very unreceptive to very receptive.

Prior to surgery, demographic information such as height, weight, age and gender, as well as medical history and surgical history of the knee will be recorded.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
50 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Men and women aged 50-80 years awaiting unilateral total knee arthroplasties
  • Willing to provide informed consent
  • Willing to be randomized to either of the post-operative treatment pathways and willing to follow the study protocol

排除标准

  • Serious cardiac, renal, hepatic, neoplastic and psychiatric diseases
  • Abnormal thyroid and adrenal function.

研究组 & 干预措施

Standard Post-op Exercise Group

No Intervention

The standard post-operative exercises are already currently recommended to patients. Briefly, they include deep breathing and coughing, ankle pumping, buttock contractions, and static quadriceps strengthening. These are performed on a daily basis , 2-3 times per day, 30 repetitions.

Viscus Group

Experimental

The Viscus (intervention) group will complete the standard post-operative exercises and will also have access to a Viscus V1.5 cycle ergometer 24 hours per day in their recovery room to use at their leisure.

干预措施: Cycle ergometer (Other)

结局指标

主要结局

Knee pain/functional status/swelling/ROM/strength

时间窗: All will be measured pre-operatively (baseline measure), and at day 2 post-operatively, upon discharge (anywhere from day 5-14 post-operatively), and 12 weeks post-operatively to observe changes from the baseline measure.

Knee pain will be measured using the visual analog scale (VAS), and functional status will be measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Knee swelling will be measured via girth measures taken 15 cm superior to the superior pole of the patella; at the supra and infrapatellar regions; and 15 cm inferior to the inferior pole of patella, and flexion and extension ROM will be measured in degrees using a goniometer. The mean of three trials of resisted isometric knee flexor and extensor strength will be measured in lbs of force using a Lafayette Manual Muscle Tester.

Blood markers of inflammation/nutritional status/thrombogenesis risk

时间窗: All will be measured pre-operatively (baseline measure), at day 2 post-operatively, and upon discharge (anywhere from day 5-14 post-operatively) to observe changes from the baseline measure.

Plasma and serum will be isolated from whole blood samples and various assays will be completed to detect markers indicative of inflammation, poor nutritional status, and increased risk of thromboembolic events.

次要结局

  • Participant motivation.(Questionnaire will be completed pre-operatively, at day 2 post-operatively, upon discharge (anywhere from 5-14 days post-operatively), and 12 weeks post-operatively.)
  • Patient compliance.(Questionnaire will be completed pre-operatively, at day 2 post-operatively, upon discharge (anywhere from 5-14 days post-operatively), and 12 weeks post-operatively.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Paolo Sanzo

Dr. Paolo Sanzo

Lakehead University

研究点 (2)

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