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临床试验/NCT05189964
NCT05189964招募中不适用

Total Hip Arthroplasty and Physical Activity in Patients Younger Than 50 Years

Radboud University Medical Center1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2021年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
90
试验地点
1
主要终点
Change from MVPA in minutes per day

研究概览

简要总结

Rationale: THA is a widely applied procedure for osteoarthritis of the hip. After THA, one can expect an increase in physical activity due to the reduction of pain and increased range of motion of the hip joint, especially in young patients who in general have more active lifestyles. However, these young patients and their doctors don't know which increase in physical activity can be expected.

Objective: To measure the difference in physical activity before and after THA. Study design: Longitudinal prospective single center observational study. Study population: 87 patients who have primary THA under the age of 50 years. Excluding patients with an underlying oncologic disease which results in THA.

Intervention: N.a. Main study parameters/endpoints: The first primary endpoint is physical activity in minutes per day. The other primary endpoint is MVPA in minutes per day. Secondary endpoints are difference of TUG outcomes in seconds and the difference of 6MWT outcomes in meters. For the patients experience, the COPM total scores and NRS pain scores will be measured.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: This study requires three outpatient clinic visits. These visits will coincide with regular outpatient clinic visits, so patients will not have to come in extra for this study. During the preoperative and 1 year postoperative visit, the patients will complete the COPM. The patient will wear a PA monitor for 7 days after each visit. Patients might experience confronting feelings while being exposed to their PA activity profile after the study or experience mild discomfort while wearing the PA monitor since it will be worn 24 hours per day for 7 days. Also, filling in the questionnaires will take some time (5-10 minutes per questionnaire series). There are no significant physical risks associated to this study.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • The age of the patient is between 16 and 50 years.
  • The patient has an indication for primary THA.

排除标准

  • Patients with an underlying oncologic disease which results in THA.
  • Patients who are not able to walk.

结局指标

主要结局

Change from MVPA in minutes per day

时间窗: preoperative, 3 months postoperative, 12 months postoperative

Change from time spent active in minutes per day

时间窗: preoperative, 3 months postoperative, 12 months postoperative

次要结局

  • 6MWT(preoperative, 3 months postoperative, 12 months postoperative)
  • COPM(preoperative, 12 months postoperative)
  • TUG(preoperative, 3 months postoperative, 12 months postoperative)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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