Impact of Volunteerism in the Acute Setting

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04063553
• Other study ID #: 2018/00638
• Status: Recruiting
• Phase: N/A
• Start date: June 16, 2019
• Est. completion date: June 15, 2020

Study information

• Verified date: August 2019
• Source: Tan Tock Seng Hospital
• Contact: Eng Chuan Neoh, Masters
• Phone: 91733222
• Email: eng_chuan_neoh[@]ttsh.com.sg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 15, 2020
• Est. primary completion date: June 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• Volunteers Service
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. All volunteers are recruited from TTSH volunteers pool managed by Center of Health Activation (CHA). TKR volunteers are trained by the study team, including a formal classroom session and a practical and role play session. After the training, volunteers need to pass 3 assessment by the physiotherapists in order to attend to patients independently by themselves. Volunteers who are bilingual will attend to the subject alone, or else those who can only converse in Chinese/ English will pair up with another volunteer who knows another language to make sure there is no communication barrier between volunteers and patients.
• Exercise brochure
. 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. The exercises in the brochure and exercises taught by the volunteers are the same. The video and brochure are available in both English and Chinese version.

Locations

Country	Name	City	State
Singapore	Tan Tock Seng Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Tan Tock Seng Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knee flexion and extension range of motion	knee range of motion will be measured using goniometer	through study completion, an average of 5 days
Primary	Quadriceps strength	Quads strength will be assessed by using handheld dynamo-meter	through study completion, an average of 5 days
Secondary	Pain intensity	pain intensity will be assessed by using VAS scale. VAS scale is a valid scale to assess pain intensity. It is a likert scale with 0-10 with 0 is no pain and 10 is maximum pain, Subject will be asked to give a number based on the pain level that they feel.	through study completion, an average of 5 days
Secondary	Timed up and Go test	Functional test to measure the duration needed to complete the task	through study completion, an average of 5 days
Secondary	Length of stay	Length of hospital stay to discharge home	through study completion, an average of 5 days
Secondary	survey	survey with likert scale 1-5 to investigate patient acceptance and satisfaction level towards volunteer service	through study completion, an average of 5 days
Secondary	quiz	quiz with Yes or No to test the knowledge of subjects about post TKR rehab	through study completion, an average of 5 days