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临床试验/NCT05031390
NCT05031390已完成不适用

the Horsens Aarhus FemoroAcetabular Impingement Syndrome Training Pilot Study

Horsens Hospital2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2021年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
15
试验地点
2
主要终点
Completion of training program

研究概览

简要总结

The aim of the study is to investigate the feasibility of a training intervention in patients with femoroacetabular impingement syndrome (FAIS).

详细描述

The aim of this study is to investigate the feasibility of a 12-weeks (progressive) exercise program in patients with FAIS. Feasibility is evaluated on the recruitment strategy, patient adherence to the exercises and their experiences with and motivation for performing exercises. Furthermore, the investigators wish to investigate the variation of data before and after the exercise program to help estimate a suitable sample size for a future randomized controlled trial.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Patients aged 18-50 years old
  • Diagnosed with FAIS according to the Warwick agreement
  • Patients having cam morphology should have an alpha angle of > 55 degrees on an anterior-posterior radiograph.
  • Patients having pincer should have a lateral centre edge angle of >39 degrees on an anterior-posterior radiograph.
  • Lateral joint space width should be >3 mm.
  • Body mass index is below
  • Motivated for participation in a 12 week training program with 8 physical attendances.

排除标准

  • Received physiotherapist-led treatment in the past 3 months,
  • Previous hip surgery in included hip or other major hip injury,
  • Systemic conditions e.g. rheumatoid arthritis, cancer,
  • Chronical pain syndromes,
  • Unable to perform testing procedures,
  • Unable to attend a 12-week treatment program or baseline and follow-up assessments
  • Contraindications to radiographs (e.g. pregnancy)
  • Unable to read or understand questionnaires and/or instructions

结局指标

主要结局

Completion of training program

时间窗: 0-12 weeks

The training program is considered completed if patients are not dropping out of the study before the end of the 12 weeks. Completion rate will be calculated as % patients who completed the study

Number of completed exercise sessions

时间窗: 0-12 weeks

Number of completed exercise sessions. A high adherence is defined as attendance of \> 75% of planned sessions

次要结局

  • Maximal hip muscle strength(Change from 0-12 weeks)
  • One-legged hop for distance(0-12 weeks)
  • The Copenhagen Hip and Groin Outcome Score (HAGOS)(Change from 0-12 weeks)
  • The Hip Sports Activity Scale (HSAS)(Change from 0-12 weeks)
  • Patient Acceptable Symptom State(0-12 weeks)
  • The International Hip Outcome Tool (iHOT-33)(Change from 0-12 weeks)
  • Y-balance board(0-12 weeks)

研究者

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

Jeppe Lange

Head of Research

Horsens Hospital

研究点 (2)

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