ClinicalTrials.gg
Status unknownNCT04063553Updated Aug 21, 2019

Impact of Volunteerism in the Acute Setting

An interventional study of Volunteers Service and Exercise brochure in Knee Osteoarthritis, sponsored by Tan Tock Seng Hospital. Status unknown at 1 site in Singapore. Open to participants aged 55 Years to 85 Years. Per ClinicalTrials.gov, last updated 2019-08-21.

Sponsored by Tan Tock Seng Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
55 Years to 85 Years
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • Knee Osteoarthritis
03

In context

Osteoarthritis, Knee

3,391 studies on the registry are indexed under Osteoarthritis, Knee; 628 are open to participants now.

This study's planned enrollment of 40 is below the median of 69 across 2,808 interventional studies indexed under Osteoarthritis, Knee.

Browse Osteoarthritis, Knee studies →

Lead sponsor

Tan Tock Seng Hospital is the lead sponsor of 108 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
55 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
40 participants (estimated)

Study arms

  • Other
    Intervention arm

    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.

    Other: Volunteers Service

  • Other
    Control arm

    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

    Other: Exercise brochure

Interventions

  • OtherVolunteers 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.

  • OtherExercise 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.

06

What researchers measure

Primary outcomes

  1. Knee flexion and extension range of motion

    knee range of motion will be measured using goniometer

    Time frame: through study completion, an average of 5 days

  2. Quadriceps strength

    Quads strength will be assessed by using handheld dynamo-meter

    Time frame: through study completion, an average of 5 days

Secondary outcomes

  1. 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.

    Time frame: through study completion, an average of 5 days

  2. Timed up and Go test

    Functional test to measure the duration needed to complete the task

    Time frame: through study completion, an average of 5 days

  3. Length of stay

    Length of hospital stay to discharge home

    Time frame: through study completion, an average of 5 days

  4. survey

    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

  5. quiz

    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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2019 (actual). Primary completion is estimated for Jun 2020, 11 months after the start.

Of 1,143 non-industry interventional studies with no phase under Osteoarthritis, Knee, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 36. This study's planned 11 months is below that.

Counting every sponsor, half of 1,285 studies reached it within 18 months; a quarter within 8 and three quarters within 36.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 16, 2019
First posted
Aug 21, 2019
StartActual
Jun 16, 2019
Primary completionEst.
Jun 15, 2020
CompletionEst.
Jun 15, 2020
Last update
Aug 21, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 21, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04063553
Responsible party
Eng Chan Neoh (Senior Physiotherapist, Tan Tock Seng Hospital) — Principal investigator
First posted
Aug 21, 2019
Start date
Jun 16, 2019
Primary completion
Jun 15, 2020 (estimated)
Completion
Jun 15, 2020 (estimated)
Last update
Aug 21, 2019

Study contacts

Eng Chuan Neoh, Masters
Contact
eng_chuan_neoh@ttsh.com.sg
91733222
Jaclyn Tan, Masters
Contact
ee_chen_tan@ttsh.com.sg
97219976
Eng Chuan Neoh, masters
principal investigator · Senior Physiotherapist

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion