Hospital-based Usual cAre Versus Tele-monitoring Rehabilitation (HUATR)

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.

Study Overview

• Status: Completed
• Conditions: Total Knee Replacement
• Intervention / Treatment: Other: Hospital-based rehabilitation program; Device: Tele-monitored home exercise program

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 Type: Interventional
• Enrollment (Actual): 114
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yong-Hao Pua, PhD; Phone Number: 63266111; Email: pua.yong.hao@sgh.com.sg

Study Locations

• Singapore
  • Singapore, Singapore, 168582
    • Singapore General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Hospital-based rehabilitation program	Other: Hospital-based rehabilitation program; 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.
Experimental: Tele-monitored home exercise program	Device: Tele-monitored home exercise program; Tele-monitoring home exercise program used in the home with monitoring by physiotherapists.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in Fast-paced gait speed	Difference in fast gait speed (over 10 metres) between the two treatment groups.	Pre-operation; 3 months and 6 months post-surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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.	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.	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.	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.	Pre-operation; 3 months and 6 months post-surgery
Cost	Cost questionnaire measuring the direct and indirect costs.	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".	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".	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".	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.	Pre-operation; 3 months and 6 months post-surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of adverse events	Adverse events (AE) and serious adverse events (SAE) will be recorded at all follow-ups by asking the participants about potential AEs using open-probe questioning to ensure that all AEs are recorded.	3 months and 6 months post-surgery

Collaborators and Investigators

• Sponsor: Singapore General Hospital
• Collaborators: Duke University; Monash University; Duke-NUS Graduate Medical School; University of the Sunshine Coast

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2020
• Primary Completion (Actual): July 13, 2023
• Study Completion (Actual): July 13, 2023

Study Registration Dates

• First Submitted: April 10, 2020
• First Submitted That Met QC Criteria: April 15, 2020
• First Posted (Actual): April 20, 2020

Study Record Updates

• Last Update Posted (Estimated): November 8, 2023
• Last Update Submitted That Met QC Criteria: November 6, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: TA18may-0007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No