跳至主要内容
临床试验/NCT04063553
NCT04063553Unknown不适用

Impact of Volunteerism in the Acute Setting: Guiding Rehabilitative Exercises in Patients After Total Knee Replacement (TKR). A Pilot Study

Tan Tock Seng Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年6月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
40
试验地点
1
主要终点
Quadriceps strength

研究概览

简要总结

Rehabilitation, with a particular emphasis on physiotherapy and exercise, is widely promoted and strongly recommended after total knee replacement (TKR). The primary goals of rehabilitation are to improve knee range-of-motion, muscle strength, functional mobility and perceived quality of life. Exercises are usually prescribed and guided by a physiotherapist attending to the patient. The intensity of rehabilitation has an impact on clinical outcome. A study done by Lee et al in 2012 concluded that higher exercise dose translates to better function after TKR, especially in older population and for those with higher pain. Various literatures has also strongly recommended twice a day rehabilitation session for patients after TKR (Cook et al, 2008; Smith et al 2012).

详细描述

Rehabilitation, with a particular emphasis on physiotherapy and exercise, is widely promoted and strongly recommended after total knee replacement (TKR). The primary goals of rehabilitation are to improve knee range-of-motion, muscle strength, functional mobility and perceived quality of life. Exercises are usually prescribed and guided by a physiotherapist attending to the patient. The intensity of rehabilitation has an impact on clinical outcome. A study done by Lee et al in 2012 concluded that higher exercise dose translates to better function after TKR, especially in older population and for those with higher pain. Various literatures has also strongly recommended twice a day rehabilitation session for patients after TKR (Cook et al, 2008; Smith et al 2012). The standard practice in the in-patient setting is that physiotherapist will attend to the TKR patients once a day and remind patients to perform exercises by themselves, following the exercise booklet given, during their free time in the ward to maximise their recovery. However, due to post-operative fatugue, pain and fearful of movement, most of the patients are not compliant to the exercises given.

Volunteers have been present in health care settings for centuries. Several studies have shown that volunteers can be an essential part of the healthcare system. They are commonly involved in non-clinical tasks such as providing emotional support to patients and families (Burbeck et al., 2014), assisting with meals (Robinson et al., 2014) and facilitating recreational activities in patients with dementia (Hall et al., 2017).

However, no study has investigated the involvement of volunteers in actual clinical work. Our study aim to explore the feasibility of volunteers involvement in teaching and guiding exercises which conventionally done by physiotherapists, and to investigate the effectiveness of such volunteer service. There is no existing evidence on volunteers dealing with elderly patients in acute stage right after surgery as well, and this clinical research will be the first to explore that.

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
Double (Investigator, Outcomes Assessor)

盲法说明

Investigator and outcome assessor will be blinded from the group allocation. Research coordinator will be the the only person handling randomization, group allocation, arrange for volunteers to attend to the patient or not, and arrange for assessor to assess the patients.

入排标准

年龄范围
55 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Standard unilateral TKR without complications
  • •55 years or older
  • •Pain less than or equal to 6/10 (i.e or between mild to moderate)
  • •Cognitively intact (able to follow at least 1-step instruction consistently)
  • •Vitals stable (Blood pressure, HR, oxygen saturation)
  • •Able to verbalise understanding and give informed consent
  • •Able to understand Mandarin or English

排除标准

  • •Unable to follow instructions consistently due to
  • •Cognitive impairment (Dementia, delirium)
  • •Behavioural issues (Confused, aggressive)
  • •Visually or hearing impaired
  • •Language illiteracy (listening)
  • •Medically unstable such as Hb drop (< 8) , acute desaturation
  • •Reduced exercises tolerance- Unable to tolerate a 20 minutes exercise session
  • •Post-operative complication such as delirium, DVT, cardiac issues.
  • •Excessive bleeding from the wound dressing

研究组 & 干预措施

Intervention arm

Other

Subjects in the intervention group will receive standard physiotherapy care and an additional volunteers session once a day for at least 3 times during their stay in the hospital. The volunteer will set up the TKR exercise video for the subjects, then supervise or guide the subjects with the exercises.

干预措施: Volunteers Service (Other)

Control arm

Other

The control group subjects will receive only standard physiotherapy care and they will be instructed to perform 1 set of exercises daily following a brochure given

干预措施: Exercise brochure (Other)

结局指标

主要结局

Quadriceps strength

时间窗: through study completion, an average of 5 days

Quads strength will be assessed by using handheld dynamo-meter

Knee flexion and extension range of motion

时间窗: through study completion, an average of 5 days

knee range of motion will be measured using goniometer

次要结局

  • Pain intensity(through study completion, an average of 5 days)
  • Length of stay(through study completion, an average of 5 days)
  • Timed up and Go test(through study completion, an average of 5 days)
  • survey(through study completion, an average of 5 days)
  • quiz(through study completion, an average of 5 days)

研究者

发起方
Tan Tock Seng Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Eng Chan Neoh

Senior Physiotherapist

Tan Tock Seng Hospital

研究点 (1)

Loading locations...

相似试验

Impact of Volunteerism in the Acute Setting | 临床试验