Clinical trial NCT04063553: Impact of Volunteerism in the Acute Setting
Official title: Impact of Volunteerism in the Acute Setting: Guiding Rehabilitative Exercises in Patients After Total Knee Replacement (TKR). A Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: Tan Tock Seng Hospital
Sponsor class: OTHER
First posted: 2019-08-21
Enrollment: 40
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomised controlled trial, eligible subjects will be randomised by research coordinator to either control or intervention group based on block randomisation with sealed envelop.
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Knee flexion and extension range of motion
timeFrame: through study completion, an average of 5 days
measure: Quadriceps strength
timeFrame: through study completion, an average of 5 days
Secondary outcomes:
measure: Pain intensity
timeFrame: through study completion, an average of 5 days
measure: Timed up and Go test
timeFrame: through study completion, an average of 5 days
measure: Length of stay
timeFrame: through study completion, an average of 5 days
measure: survey
timeFrame: through study completion, an average of 5 days
measure: quiz
timeFrame: through study completion, an average of 5 days
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital
Study officials:
affiliation: Senior Physiotherapist
name: Eng Chuan Neoh, masters
role: PRINCIPAL_INVESTIGATOR
References: