Impact of Volunteerism in the Acute Setting

NCT04063553 | Unknown

• 1 other identifier: 2018/00638
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (2)

• Knee flexion and extension range of motion

  knee range of motion will be measured using goniometer

  through study completion, an average of 5 days

• Quadriceps strength

  Quads strength will be assessed by using handheld dynamo-meter

  through study completion, an average of 5 days

Secondary Outcomes (5)

• Pain intensity

  through study completion, an average of 5 days

• Timed up and Go test

  through study completion, an average of 5 days

• Length of stay

  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

Study Arms (2)

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.

Other: Volunteers Service

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

Other: Exercise brochure

Interventions

Volunteers Service 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. 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 arm

Exercise brochure 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. 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.

Control arm

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Standard unilateral TKR without complications
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tan Tock Seng Hospital: lead

Study Sites (1)

Tan Tock Seng Hospital

Singapore, Singapore

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Eng Chuan Neoh, masters

  Senior Physiotherapist

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eng Chuan Neoh, Masters

CONTACT

91733222; eng_chuan_neoh@ttsh.com.sg

Jaclyn Tan, Masters

CONTACT

97219976; ee_chen_tan@ttsh.com.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Physiotherapist

Model Details: 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.

Study Record Dates

• First Submitted: August 16, 2019
• First Posted: August 21, 2019
• Study Start: June 16, 2019
• Primary Completion: June 15, 2020
• Study Completion: June 15, 2020
• Last Updated: August 21, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)