Total Knee ReplacementHUATRNCT04352972
Hospital-based Usual cAre Versus Tele-monitoring Rehabilitation
A study testing Tele-monitored home exercise program and Hospital-based rehabilitation program in people with Total Knee Replacement, run by Singapore General Hospital at 1 site in Singapore.
Trial summary
Knee osteoarthritis (OA) is a common, chronic, and costly condition, and patients with advanced knee OA and severe disability often require a total knee replacement (TKR) surgery. In Singapore, after TKR surgery, nearly all patients who are home discharged are referred to hospital-based outpatient rehabilitation. Read more about this study
- Who is it for?
- Ages 45 to 95 years
- Conditions the study is for
- Total Knee Replacement
- What is being tested?
- Tele-monitored home exercise program and Hospital-based rehabilitation program
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteSingapore
- Study dates
- 7 Jul 2020to 13 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary unilateral total knee replacement
- Age >= 45 years
- Willingness to be randomized to either tele-monitored home exercise program or outpatient rehabilitation program
- Ability to provide informed consent
Who cannot join
- Further lower limb joint replacement surgery anticipated within the next 6 months
- Rheumatoid arthritis and other systemic arthritis
- A previous history of stroke and other major neurological conditions
- An intention to transfer to step-down care facilities post-operatively.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Innovative Tele-monitored Home-Based Program for Post Total Knee Replacement Rehabilitation: A Noninferiority Randomized Controlled Trial
Knee osteoarthritis (OA) is a common, chronic, and costly condition, and patients with advanced knee OA and severe disability often require a total knee replacement (TKR) surgery. In Singapore, after TKR surgery, nearly all patients who are home discharged are referred to hospital-based outpatient rehabilitation. Although outpatient rehabilitation attendance is associated with better functional outcomes, access to rehabilitation care is limited as outpatient rehabilitation is costly and inconvenient for patients and their caregivers, resulting in suboptimal adherence. A tele-monitored home-based exercise program provides the best access to rehabilitation care and is a potential alternative for the majority of patients who do not require intensive "hands-on" rehabilitation therapy.
The primary aim of this non-inferiority randomized controlled trial is to compare patient functional outcomes and cost-effectiveness of an innovative tele-monitored rehabilitation program versus that of currently standard, hospital-based outpatient rehabilitation program among patients post TKR.
Read the detailed description
Study Hypotheses
Primary hypothesis: A 10-week home-based exercise program, combined with tele-monitoring of functional outcomes, will not be inferior to an 10-week hospital-based rehabilitation at 3 and at 6 months after total knee replacement (TKR) in improving physical function (fast gait speed).
Secondary hypothesis 1: A 10-week home-based exercise program, combined with tele-monitoring of functional outcomes, will not be inferior to a 10-week hospital-based rehabilitation at 3 and at 6 months after TKR in improving knee pain, physical impairments, and health-related quality of life.
Secondary hypothesis 2: A 10-week tele-monitored home-based exercise program will be more cost-effective than the 10-week hospital-based rehabilitation in total TKR-related costs
Approach and Methods
This will be an assessor-blinded, parallel design, non-inferiority randomised controlled trial, with assessments preoperatively(baseline), 3 months, and 6 months after total knee replacement surgery. The protocol conforms to the CONSORT guidelines for non-inferiority randomized controlled trials. Post TKR, all participants will undergo daily inpatient rehabilitation. At discharge, they will be given a standard booklet with advice on ice therapy and home exercises to be performed. Two weeks post TKR, randomization will occur and participants will be randomised to receive either the telemonitored home exercise program or the hospital-based rehabilitation program.
- Conditions
- Total Knee Replacement
- Being tested
- Tele-monitored home exercise program, Hospital-based rehabilitation program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tele-monitored home exercise programDevice
Tele-monitoring home exercise program used in the home with monitoring by physiotherapists.
Hospital-based rehabilitation programOther
Participants will receive a maximum of 8 sessions over 10 weeks with the option of two additional sessions. Participants will receive exercises, patient education, manual therapy and other modalities that were prescribed and progressed at the project physiotherapist's discretion. Participants will also receive a set of home exercises and they will be instructed to exercise on days when not attending rehabilitation.
| Study group | Role | What they receive |
|---|---|---|
| Hospital-based rehabilitation program | Active comparator | Not described Receives: Other: Hospital-based rehabilitation program |
| Tele-monitored home exercise program | Experimental | Not described Receives: Device: Tele-monitored home exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Fast-paced gait speed
Difference in fast gait speed (over 10 metres) between the two treatment groups.
Measured: Pre-operation; 3 months and 6 months post-surgery
Secondary outcomes (11)
Knee injury and Osteoarthritis Outcome Score (KOOS)
The physical function subscale of the Knee injury and Osteoarthritis Outcome Score (KOOS) is designed to evaluate the patient's opinion about their physical function. All items are scored on 5-point Likert scales. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for the subscale.
Measured: Pre-operation; 3 months and 6 months post-surgery
Quadriceps muscle strength
Maximum voluntary isometric torque of the quadriceps muscles (at 70 degrees knee flexion) will be measured using a Biodex dynamometer
Measured: Pre-operation; 3 months and 6 months post-surgery
30s chair stand test
Total number of sit-to-stand repetitions completed in 30 seconds will be recorded. This is a measure of lower limb strength and endurance.
Measured: Pre-operation; 3 months and 6 months post-surgery
Knee Pain: Numeric Pain Rating Scale (NPRS)
Knee pain intensity during climbing stairs, walking, and sitting-to-standing will be measured using separate 11-point numeric pain rating scale, with zero representing no pain at all and 10 representing worst imaginable pain.
Measured: Pre-operation; 3 months and 6 months post-surgery
Knee range-of-motion
A long-arm goniometer will be used to measure active-assisted knee flexion and extension range-of-motion with the participants in supine position.
Measured: Pre-operation; 3 months and 6 months post-surgery
EuroQol-5 Dimensions (EQ-5D-5L) descriptive system
The EuroQol-5 Dimensions (EQ-5D-5L) is a standardised instrument to measure health related quality of life in cost-effectiveness analysis. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patients' decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
Measured: Pre-operation; 3 months and 6 months post-surgery
Cost
Cost questionnaire measuring the direct and indirect costs.
Measured: 3 months and 6 months post-surgery
Treatment satisfaction: scale
Participants will rate their satisfaction with treatment on a 11 point likert scale, with 0 indicating "no satisfaction" and 10 indicating "complete satisfaction".
Measured: 3 months post-surgery
Treatment credibility
To assess participants' confidence about the benefits of the intervention. Participants will rate their satisfaction with treatment on a 11 point likert scale, with 0 indicating "not confident" and 10 indicating "extremely confident".
Measured: 3 months post-surgery
STarT Back Screening Tool
The psychological subscale of the STarT Back Screening Tool will be determined by summing all items related to fear, anxiety, catastrophizing, depression, and bothersomeness. The STarT Back Screening Tool will be modified for use in the total knee replacement population by replacing the word "back" with "knee".
Measured: Pre-operation; 3 months and 6 months post-surgery
Örebro Musculoskeletal Pain Screening Questionnaire (short form)
This 10 item questionnaire evaluates psychological factors that potentially influence pain and/or function. These items are scored 0-10, where 0 refers to absence of impairment and 10 to severe impairment. Three items need to be reversed in order for all the questions to be oriented in the same direction. The total score will range between 1 and 100. A score above 50 indicates higher estimated risk for future work disability.
Measured: Pre-operation; 3 months and 6 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2020
- Study start7 Jul 2020
- Primary completion13 Jul 2023
- Study completion13 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Total Knee ReplacementStudies of the same condition, open and under way.
- More trials run by Singapore General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of the Sunshine Coast, Duke University, Duke-NUS Graduate Medical School, Monash University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04352972
- Sponsor's protocol ID
- TA18may-0007
- Acronym
- HUATR
- Status last verified
- Nov 2023
- First submitted
- 10 Apr 2020
- Last updated
- 8 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Pua YH, Koh SS, Terluin B, Woon EL, Chew ES, Yeo SJ, Chen JY, Liow LMH, Clark R, Thumboo J. Effect of Context Specificity on Response to the Shortened WOMAC Function Scale in Patients Undergoing Total Knee Arthroplasty. Arch Phys Med Rehabil. 2024 Sep;105(9):1725-1732. doi: 10.1016/j.apmr.2024.05.005. Epub 2024 May 7.
PubMed 38723858Pua YH, Yeo SJ, Clark RA, Tan BY, Haines T, Bettger JP, Woon EL, Tan HH, Tan JW, Low J, Chew E, Thumboo J. Cost and outcomes of Hospital-based Usual cAre versus Tele-monitor self-directed Rehabilitation (HUATR) in patients with total knee arthroplasty: A randomized, controlled, non-inferiority trial. Osteoarthritis Cartilage. 2024 May;32(5):601-611. doi: 10.1016/j.joca.2023.11.017. Epub 2023 Dec 2.
PubMed 38049030
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovative Tele-monitored Home-Based Program for Post Total Knee Replacement Rehabilitation: A Noninferiority Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04352972
- Acronym / sponsor ID
- HUATR / TA18may-0007
- Conditions
- Total Knee Replacement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Collaborators
- University of the Sunshine Coast, Duke University, Duke-NUS Graduate Medical School, Monash University
- Study start
- 7 Jul 2020 (actual)
- Primary completion
- 13 Jul 2023 (actual)
- Study completion
- 13 Jul 2023 (actual)
- First posted
- 20 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Knee osteoarthritis (OA) is a common, chronic, and costly condition, and patients with advanced knee OA and severe disability often require a total knee replacement (TKR) surgery. In Singapore, after TKR surgery, nearly all patients who are home discharged are referred to hospital-based outpatient rehabilitation. Although outpatient rehabilitation attendance is associated with better functional outcomes, access to rehabilitation care is limited as outpatient rehabilitation is costly and inconvenient for patients and their caregivers, resulting in suboptimal adherence. A tele-monitored home-based exercise program provides the best access to rehabilitation care and is a potential alternative for the majority of patients who do not require intensive "hands-on" rehabilitation therapy.
The primary aim of this non-inferiority randomized controlled trial is to compare patient functional outcomes and cost-effectiveness of an innovative tele-monitored rehabilitation program versus that of currently standard, hospital-based outpatient rehabilitation program among patients post TKR.
Detailed description
Study Hypotheses
Primary hypothesis: A 10-week home-based exercise program, combined with tele-monitoring of functional outcomes, will not be inferior to an 10-week hospital-based rehabilitation at 3 and at 6 months after total knee replacement (TKR) in improving physical function (fast gait speed).
Secondary hypothesis 1: A 10-week home-based exercise program, combined with tele-monitoring of functional outcomes, will not be inferior to a 10-week hospital-based rehabilitation at 3 and at 6 months after TKR in improving knee pain, physical impairments, and health-related quality of life.
Secondary hypothesis 2: A 10-week tele-monitored home-based exercise program will be more cost-effective than the 10-week hospital-based rehabilitation in total TKR-related costs
Approach and Methods
This will be an assessor-blinded, parallel design, non-inferiority randomised controlled trial, with assessments preoperatively(baseline), 3 months, and 6 months after total knee replacement surgery. The protocol conforms to the CONSORT guidelines for non-inferiority randomized controlled trials. Post TKR, all participants will undergo daily inpatient rehabilitation. At discharge, they will be given a standard booklet with advice on ice therapy and home exercises to be performed. Two weeks post TKR, randomization will occur and participants will be randomised to receive either the telemonitored home exercise program or the hospital-based rehabilitation program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hospital-based rehabilitation program | Active comparator | Other: Hospital-based rehabilitation program |
| Tele-monitored home exercise program | Experimental | Device: Tele-monitored home exercise program |
Who may qualify
- Ages
- 45 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Primary unilateral total knee replacement
- Age >= 45 years
- Willingness to be randomized to either tele-monitored home exercise program or outpatient rehabilitation program
- Ability to provide informed consent
Key exclusion criteria (4 listed)
- Further lower limb joint replacement surgery anticipated within the next 6 months
- Rheumatoid arthritis and other systemic arthritis
- A previous history of stroke and other major neurological conditions
- An intention to transfer to step-down care facilities post-operatively.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tele-monitored home exercise programTele-monitoring home exercise program used in the home with monitoring by physiotherapists. | Device | Tele-monitored home exercise program |
| Hospital-based rehabilitation programParticipants will receive a maximum of 8 sessions over 10 weeks with the option of two additional sessions. Participants will receive exercises, patient education, manual therapy and other modalities that were prescribed and progressed at the project physiotherapist's discretion. Participants will also receive a set of home exercises and they will be instructed to exercise on days when not attending rehabilitation. | Other | Hospital-based rehabilitation program |
Primary outcome
Difference in Fast-paced gait speed
Time frame: Pre-operation; 3 months and 6 months post-surgery
Difference in fast gait speed (over 10 metres) between the two treatment groups.
11 secondary outcomes
Knee injury and Osteoarthritis Outcome Score (KOOS)
Time frame: Pre-operation; 3 months and 6 months post-surgery
Quadriceps muscle strength
Time frame: Pre-operation; 3 months and 6 months post-surgery
30s chair stand test
Time frame: Pre-operation; 3 months and 6 months post-surgery
Knee Pain: Numeric Pain Rating Scale (NPRS)
Time frame: Pre-operation; 3 months and 6 months post-surgery
Knee range-of-motion
Time frame: Pre-operation; 3 months and 6 months post-surgery
EuroQol-5 Dimensions (EQ-5D-5L) descriptive system
Time frame: Pre-operation; 3 months and 6 months post-surgery
Cost
Time frame: 3 months and 6 months post-surgery
Treatment satisfaction: scale
Time frame: 3 months post-surgery
Treatment credibility
Time frame: 3 months post-surgery
STarT Back Screening Tool
Time frame: Pre-operation; 3 months and 6 months post-surgery
Örebro Musculoskeletal Pain Screening Questionnaire (short form)
Time frame: Pre-operation; 3 months and 6 months post-surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2023.
- Derived from this study: PubMed 38723858Pua YH, Koh SS, Terluin B, Woon EL, Chew ES, Yeo SJ, Chen JY, Liow LMH, Clark R, Thumboo J. Effect of Context Specificity on Response to the Shortened WOMAC Function Scale in Patients Undergoing Total Knee Arthroplasty. Arch Phys Med Rehabil. 2024 Sep;105(9):1725-1732. doi: 10.1016/j.apmr.2024.05.005. Epub 2024 May 7.
- Derived from this study: PubMed 38049030Pua YH, Yeo SJ, Clark RA, Tan BY, Haines T, Bettger JP, Woon EL, Tan HH, Tan JW, Low J, Chew E, Thumboo J. Cost and outcomes of Hospital-based Usual cAre versus Tele-monitor self-directed Rehabilitation (HUATR) in patients with total knee arthroplasty: A randomized, controlled, non-inferiority trial. Osteoarthritis Cartilage. 2024 May;32(5):601-611. doi: 10.1016/j.joca.2023.11.017. Epub 2023 Dec 2.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tele-monitored home exercise program and Hospital-based rehabilitation program in people with Total Knee Replacement, run by Singapore General Hospital at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in Fast-paced gait speed (time frame: Pre-operation; 3 months and 6 months post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04352972, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2023.