Hospital-based Usual cAre Versus Tele-monitoring Rehabilitation
- Conditions
- Total Knee Replacement
- Interventions
- Device: Tele-monitored home exercise programOther: Hospital-based rehabilitation program
- Registration Number
- NCT04352972
- Lead Sponsor
- Singapore General Hospital
- Brief 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. 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 114
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tele-monitored home exercise program Tele-monitored home exercise program - Hospital-based rehabilitation program Hospital-based rehabilitation program -
- Primary Outcome Measures
Name Time Method Difference in Fast-paced gait speed Pre-operation; 3 months and 6 months post-surgery Difference in fast gait speed (over 10 metres) between the two treatment groups.
- Secondary Outcome Measures
Name Time Method Knee Pain: Numeric Pain Rating Scale (NPRS) Pre-operation; 3 months and 6 months post-surgery 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.
STarT Back Screening Tool Pre-operation; 3 months and 6 months post-surgery 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".
30s chair stand test Pre-operation; 3 months and 6 months post-surgery Total number of sit-to-stand repetitions completed in 30 seconds will be recorded. This is a measure of lower limb strength and endurance.
Knee injury and Osteoarthritis Outcome Score (KOOS) Pre-operation; 3 months and 6 months post-surgery 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.
Treatment credibility 3 months post-surgery 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".
Quadriceps muscle strength Pre-operation; 3 months and 6 months post-surgery Maximum voluntary isometric torque of the quadriceps muscles (at 70 degrees knee flexion) will be measured using a Biodex dynamometer
Treatment satisfaction: scale 3 months post-surgery Participants will rate their satisfaction with treatment on a 11 point likert scale, with 0 indicating "no satisfaction" and 10 indicating "complete satisfaction".
Knee range-of-motion Pre-operation; 3 months and 6 months post-surgery A long-arm goniometer will be used to measure active-assisted knee flexion and extension range-of-motion with the participants in supine position.
EuroQol-5 Dimensions (EQ-5D-5L) descriptive system Pre-operation; 3 months and 6 months post-surgery 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.
Cost 3 months and 6 months post-surgery Cost questionnaire measuring the direct and indirect costs.
Örebro Musculoskeletal Pain Screening Questionnaire (short form) Pre-operation; 3 months and 6 months post-surgery 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.
Trial Locations
- Locations (1)
Singapore General Hospital
🇸🇬Singapore, Singapore