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Impact of Volunteerism in the Acute Setting

Primary Purpose

Knee Osteoarthritis

Status
Unknown status
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Volunteers Service
Exercise brochure
Sponsored by
Tan Tock Seng Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

55 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tan Tock Seng HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Intervention arm

Control arm

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Knee flexion and extension range of motion
knee range of motion will be measured using goniometer
Quadriceps strength
Quads strength will be assessed by using handheld dynamo-meter

Secondary Outcome Measures

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.
Timed up and Go test
Functional test to measure the duration needed to complete the task
Length of stay
Length of hospital stay to discharge home
survey
survey with likert scale 1-5 to investigate patient acceptance and satisfaction level towards volunteer service
quiz
quiz with Yes or No to test the knowledge of subjects about post TKR rehab

Full Information

First Posted
August 16, 2019
Last Updated
August 20, 2019
Sponsor
Tan Tock Seng Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04063553
Brief Title
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

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 16, 2019 (Actual)
Primary Completion Date
June 15, 2020 (Anticipated)
Study Completion Date
June 15, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tan Tock Seng Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
InvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention arm
Arm Type
Other
Arm Description
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.
Arm Title
Control arm
Arm Type
Other
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Volunteers Service
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Exercise brochure
Intervention Description
. 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.
Primary Outcome Measure Information:
Title
Knee flexion and extension range of motion
Description
knee range of motion will be measured using goniometer
Time Frame
through study completion, an average of 5 days
Title
Quadriceps strength
Description
Quads strength will be assessed by using handheld dynamo-meter
Time Frame
through study completion, an average of 5 days
Secondary Outcome Measure Information:
Title
Pain intensity
Description
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.
Time Frame
through study completion, an average of 5 days
Title
Timed up and Go test
Description
Functional test to measure the duration needed to complete the task
Time Frame
through study completion, an average of 5 days
Title
Length of stay
Description
Length of hospital stay to discharge home
Time Frame
through study completion, an average of 5 days
Title
survey
Description
survey with likert scale 1-5 to investigate patient acceptance and satisfaction level towards volunteer service
Time Frame
through study completion, an average of 5 days
Title
quiz
Description
quiz with Yes or No to test the knowledge of subjects about post TKR rehab
Time Frame
through study completion, an average of 5 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eng Chuan Neoh, Masters
Phone
91733222
Email
eng_chuan_neoh@ttsh.com.sg
First Name & Middle Initial & Last Name or Official Title & Degree
Jaclyn Tan, Masters
Phone
97219976
Email
ee_chen_tan@ttsh.com.sg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eng Chuan Neoh, masters
Organizational Affiliation
Senior Physiotherapist
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tan Tock Seng Hospital
City
Singapore
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eng Chuan Neoh, masters
Phone
91733222
Email
eng_chuan_neoh@ttsh.com.sg

12. IPD Sharing Statement

Plan to Share IPD
No

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Impact of Volunteerism in the Acute Setting

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