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临床试验/NCT06341920
NCT06341920招募中不适用

BoneFit: A Student-led Multimodal Prehabilitation Service for Orthopaedic Surgical Patients in Hull

University of Hull1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年5月16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
50
试验地点
1
主要终点
Recruitment

研究概览

简要总结

To conduct a pilot feasibility study to determine the effect of a student-led prehabilitation service in people awaiting total hip or knee replacement surgery.

详细描述

The aim of BoneFit is to provide local people living in the Hull region with a needs-based prehabilitation care package to improve their physical and mental health, quality of life & reduce their length of hospital stay, complications and readmission rates to hospital following orthopaedic surgery (total hip replacement, or total knee replacement.

Currently, Hull University Teaching Hospitals do not offer a prehabilitation service for local patients. The University of Hull will partner with them to provide a student-led multimodal prehabilitation service for referred patients awaiting orthopaedic surgery.

研究设计

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

盲法说明

Masking is not possible - referrals/care providers know whether they/referral is involved in the intervention or not.

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Waiting for unilateral total hip or knee replacement surgery for a minimum of 6 months;
  • Able to provide informed consent;

排除标准

  • Previous hip or knee surgery;
  • Any medical conditions for which moderate to vigorous exercise is contraindicated;
  • Patellar or hip joint instability;
  • Any other disease/condition which severely effects functional performance e.g. stroke or Parkinson's disease;
  • Chronic depression or significant psychiatric disorder;
  • Enrolled in a clinical trial (or recently completed one);
  • Cognitive impairment which would affect compliance to BoneFIt service;
  • Patients unable or unwilling to commit to required study follow-ups
  • Pregnancy;

结局指标

主要结局

Recruitment

时间窗: 2 years

Number of people recruited and trained

Adherence and attendance

时间窗: 2.5 years

Record the number of sessions attended and calculate adherence to protocol (%)

Acceptability

时间窗: 3 years

Conduct semi-structured interviews following the intervention with sample of participants and ask them about experiences of the intervention. The post-intervention interviews will focus on how participants viewed the intervention, perceived burdens, and perceived effectiveness from initiation through to completion. A list of burdens / perceived benefits will be reported alongside percentage rates of respondents.

次要结局

  • Readmission rates(3 years)
  • Length of stay(3 years)
  • Physical fitness(3 years)
  • Overall quality of life(3 years)
  • Knee or hip specific pain, function and quality of life(3 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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