Remote Exercise Program for Knee Replacement

(MOST Energized Trial)

Overseen By Christine Pellegrini, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of South Carolina

Disqualifiers: Scheduled surgery, Mobility limiting, BMI >40, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 6 months

336 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It mainly focuses on your physical activity and knee replacement history.

What data supports the effectiveness of the treatment 'Hear from Others' Videos, Individualized Feedback, Online exercise program, Phone Coaching, Progress reports to providers for knee replacement?

Research shows that structured telephone follow-up can improve patient compliance with home exercises after knee replacement, and using patient-reported outcome measures (PROMs) can enhance treatment outcomes by providing valuable feedback to both patients and providers. These elements suggest that the components of the remote exercise program, such as phone coaching and progress reports, may be effective in improving recovery after knee replacement. ^{1 2 3 4 5}

Is the remote exercise program for knee replacement safe for humans?

Research shows that home-based exercise programs, including digital coaching and smartphone-based systems, are generally safe for people after knee replacement surgery, as they are not inferior to traditional in-person therapy. ^{6 7 8 9 10}

How is the 'Remote Exercise Program for Knee Replacement' treatment different from other treatments for knee replacement recovery?

This treatment is unique because it combines 'Hear from Others' videos, individualized feedback, an online exercise program, phone coaching, and progress reports to providers, which together aim to enhance adherence and improve recovery. Unlike traditional supervised programs, this approach leverages remote and digital tools to support patients in their home environment, potentially increasing convenience and engagement. ^{3 9 11 12 13}

What is the purpose of this trial?

The purpose of this study is to identify which supplemental intervention components added to an online exercise program contribute to the greatest increases in physical activity (total MVPA and percent meeting guidelines \[≥150 min/week of MVPA\]) in adults with knee replacement at 6 and 12 months. Secondary outcomes will examine changes in pain and physical function.

Research Team

Christine Pellegrini, PhD

Principal Investigator

University of South Carolina

Jessica Unick, PhD

Principal Investigator

The Miriam Hospital

Eligibility Criteria

This trial is for adults who had a knee replacement at least a year ago, are not very active (less than 60 minutes of moderate exercise per week), and can access the internet. They should be willing to try an online exercise program and additional support methods. People with health issues that limit mobility, those already in physical therapy or other programs, or planning surgery within a year cannot join.

Inclusion Criteria

I had a knee replacement surgery over a year ago.

Be willing to complete the 4 remote assessments, including physical activity monitoring

Have a computer, tablet, or smartphone with active internet access

Exclusion Criteria

Any contraindications to physical activity (e.g., chest pain)

Are participating in a structured weight loss or physical activity program

Score >30 on PROMIS cognitive function

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 6-month, fully automated online behavioral exercise program designed to increase moderate-intensity physical activity

6 months

Weekly video lessons during months 1-3, monthly lessons during months 4-6

Follow-up

Participants are monitored for changes in physical activity, pain, and physical function

6 months

Treatment Details

Interventions

• 'Hear from Others' Videos
• Individualized Feedback
• Online exercise program
• Phone Coaching
• Progress reports to providers

Trial Overview The study tests how well different supports like motivational videos, progress reports to doctors, phone coaching, and personalized feedback work alongside an online exercise program to help people with knee replacements become more physically active and improve their pain and function.

Participant Groups

Group I: Experimental condition 9 Experimental Treatment 4 Interventions

Energize Online Program plus progress reports to physicians, 'Hear From Others' videos, and individualized feedback

Group II: Experimental condition 8 Experimental Treatment 2 Interventions

Energize Online Program plus phone coaching

Group III: Experimental condition 7 Experimental Treatment 3 Interventions

Energize Online Program plus phone coaching and individualized feedback

Group IV: Experimental condition 6 Experimental Treatment 3 Interventions

Energize Online Program plus phone coaching and 'Hear From Others' videos

Group V: Experimental condition 5 Experimental Treatment 4 Interventions

Energize Online Program plus phone coaching, 'Hear From Others' videos, and individualized feedback

Group VI: Experimental condition 4 Experimental Treatment 3 Interventions

Energize Online Program plus phone coaching and progress reports to physicians

Group VII: Experimental condition 3 Experimental Treatment 4 Interventions

Energize Online Program plus phone coaching, progress reports to physicians, and individualized feedback

Group VIII: Experimental condition 2 Experimental Treatment 4 Interventions

Energize Online Program plus phone coaching, progress reports to physicians, and 'Hear From Others' videos

Group IX: Experimental condition 16 Experimental Treatment 1 Intervention

Energize Online Program

Group X: Experimental condition 15 Experimental Treatment 2 Interventions

Energize Online Program plus individualized feedback

Group XI: Experimental condition 14 Experimental Treatment 2 Interventions

Energize Online Program plus 'Hear From Others' videos

Group XII: Experimental condition 13 Experimental Treatment 3 Interventions

Energize Online Program plus 'Hear From Others' videos and individualized feedback

Group XIII: Experimental condition 12 Experimental Treatment 2 Interventions

Energize Online Program plus progress reports to physicians

Group XIV: Experimental condition 11 Experimental Treatment 3 Interventions

Energize Online Program plus progress reports to physicians and individualized feedback

Group XV: Experimental condition 10 Experimental Treatment 3 Interventions

Energize Online Program plus progress reports to physicians and 'Hear From Others' videos

Group XVI: Experimental condition 1 Experimental Treatment 5 Interventions

Energize Online Program plus phone coaching, progress reports to physicians, 'Hear From Others' videos, and individualized feedback

Who Is Running the Clinical Trial?

University of South Carolina

Lead Sponsor

Trials

233

Recruited

122,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Findings from Research

A study involving 202 elderly patients showed that structured telephone follow-up after total knee arthroplasty (TKA) significantly increased home-exercise compliance compared to routine care.

Both groups experienced improvements in pain, functional ability, and quality of life after TKA, but the intervention group showed greater enhancements in mental health and active range of motion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of structured telephone follow-up on patient compliance with rehabilitation after total knee arthroplasty. Chen, M., Li, P., Lin, F.[2020]

Patient-reported outcome measures (PROMs) are becoming essential in total knee arthroplasty as they help improve patient outcomes and align with the shift towards value-based healthcare in the U.S.

Electronic platforms for collecting and analyzing PROMs provide real-time data that enhances shared decision-making and allows for better comparisons of care quality among different healthcare practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of Patient-reported Outcome Measures in Total Knee Arthroplasty. Ayers, DC.[2022]

The 'Virtual Clinic' follow-up system for hip and knee replacement patients achieved a 36% compliance rate, with 710 out of 1405 contactable patients completing the process, demonstrating its feasibility for patient monitoring.

Surgeons identified 23% of patients as needing face-to-face assessments based on their Oxford scores, leading to the detection of 14 patients requiring revision surgery, highlighting the system's effectiveness in managing post-operative care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Two and a half years on: data and experiences establishing a 'Virtual Clinic' for joint replacement follow up. Lovelock, T., O'Brien, M., Young, I., et al.[2019]

The study emphasizes the importance of using patient-reported outcomes to guide treatment decisions and improve care quality in total knee arthroplasty, highlighting the need for clinicians and hospital managers to interpret these outcomes effectively.

It suggests that research should focus on identifying best practices to reduce variations in patient health status before surgery and to customize care pathways, ensuring safer and more effective treatment for individual patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Research Priorities for Optimal Use of Patient-reported Outcomes in Quality and Outcome Improvement for Total Knee Arthroplasty. Franklin, PD.[2017]

A study involving 621 participants compared a home-based rehabilitation program (CORKA) to traditional outpatient physiotherapy after knee arthroplasty, finding no significant differences in patient outcomes at 6 or 12 months.

The CORKA program was found to be more cost-effective, saving £66 per participant and reducing total societal costs by £316, suggesting it could be a viable alternative to usual care despite similar effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outpatient physiotherapy versus home-based rehabilitation for patients at risk of poor outcomes after knee arthroplasty: CORKA RCT. Barker, KL., Room, J., Knight, R., et al.[2021]

A study involving 202 participants undergoing total knee replacement (TKR) found that combining telephonic health coaching (THC) with financial incentives (FI) significantly increased physical activity levels, with the THC + FI group achieving an average of 1,808 more steps per day compared to the control group.

The dual intervention not only improved daily step counts but also led to a notable increase in weekly physical activity, demonstrating that financial incentives and health coaching can effectively motivate individuals to enhance their post-surgery activity levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Financial Incentives and Health Coaching to Improve Physical Activity Following Total Knee Replacement: A Randomized Controlled Trial. Losina, E., Collins, JE., Deshpande, BR., et al.[2020]

In a review of 112 randomized controlled trials on post-operative rehabilitation for total knee replacement, 63% did not report on exercise adherence, highlighting a significant gap in the quality of reporting.

The overall quality of the studies was poor, with 85% showing high or unclear risk of bias, and only 21% of the reporting criteria from the Consensus for Exercise Reporting Tool (CERT) being adequately fulfilled.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reporting of post-operative rehabilitation interventions for Total knee arthroplasty: a scoping review. Bakaa, N., Chen, LH., Carlesso, L., et al.[2022]

A smartphone-based exercise educational care management system showed non-inferiority to traditional in-person physiotherapy after knee arthroplasty, with similar outcomes in knee range of motion and functional tests over 90 days.

Patients using the smartphone system required significantly less physiotherapy and had fewer emergency department visits, suggesting potential for reduced postoperative costs and improved patient engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

2021 Mark Coventry Award: Use of a smartphone-based care platform after primary partial and total knee arthroplasty: a prospective randomized controlled trial. Crawford, DA., Duwelius, PJ., Sneller, MA., et al.[2021]

The study investigates whether an accelerometer-based activity coaching system can enhance adherence to home-based exercise programs after total knee arthroplasty (TKA), with 110 participants divided into intervention and control groups.

The primary outcome is physical functioning, assessed through the Timed Up and Go test at multiple time points, aiming to determine if the coaching system improves recovery compared to standard home-based exercises.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of the use of a digital activity coaching system in addition to a two-week home-based exercise program in patients after total knee arthroplasty: study protocol for a randomized controlled trial. Harmelink, KEM., Zeegers, AVCM., Tönis, TM., et al.[2018]

In a study of 52 individuals aged 60-75 who underwent total knee replacement, those using customized home-based exergaming showed significantly greater improvements in mobility compared to those following a standard exercise protocol, particularly in the Timed Up and Go test at 2 and 4 months post-surgery.

Both groups reported meaningful improvements in knee-related function and pain, with 100% satisfaction in the exergaming group compared to 74% in the standard exercise group, indicating that exergaming may enhance patient satisfaction after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a home-based, exergaming intervention on physical function and pain after total knee replacement in older adults: a randomised controlled trial. Janhunen, M., Katajapuu, N., Paloneva, J., et al.[2023]

A systematic review of 11 randomized trials involving 1861 participants found that remote exercise programs can lead to clinically meaningful improvements in knee pain for individuals with osteoarthritis, although only one trial showed significant differences between groups.

The most effective interventions included personalized communication to tailor the exercise programs, highlighting the importance of engagement in remote management strategies for knee OA pain relief.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of remote exercise programs in reducing pain for patients with knee osteoarthritis: A systematic review of randomized trials. McHugh, CG., Kostic, AM., Katz, JN., et al.[2022]

A randomized controlled trial involving 142 patients showed that a 2-week interactive virtual telerehabilitation program is as effective as conventional outpatient physical therapy in improving knee function after total knee arthroplasty.

Both rehabilitation methods led to significant improvements in knee movement, muscle strength, walking speed, and pain levels, suggesting that telerehabilitation could be a viable option for patients who face challenges in attending traditional therapy sessions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of an interactive virtual telerehabilitation system in patients after total knee arthoplasty: a randomized controlled trial. Piqueras, M., Marco, E., Coll, M., et al.[2022]

A 12-week exercise program delivered via videoconferencing significantly improved knee pain and function in 20 elderly participants, as measured by the WOMAC score, with all domains showing improvement (P < 0.003).

Participants also experienced a 44% increase in quadriceps muscle strength and a 13% increase in balance (Berg's Balance Scale) (both P < 0.001), while over 80% found the videoconferencing method user-friendly and convenient.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A community-based exercise programme for older persons with knee pain using telemedicine. Wong, YK., Hui, E., Woo, J.[2019]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Influence of structured telephone follow-up on patient compliance with rehabilitation after total knee arthroplasty. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Implementation of Patient-reported Outcome Measures in Total Knee Arthroplasty. [2022]

3. Australia pubmed.ncbi.nlm.nih.gov

Two and a half years on: data and experiences establishing a 'Virtual Clinic' for joint replacement follow up. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Research Priorities for Optimal Use of Patient-reported Outcomes in Quality and Outcome Improvement for Total Knee Arthroplasty. [2017]

5. England pubmed.ncbi.nlm.nih.gov

Outpatient physiotherapy versus home-based rehabilitation for patients at risk of poor outcomes after knee arthroplasty: CORKA RCT. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Financial Incentives and Health Coaching to Improve Physical Activity Following Total Knee Replacement: A Randomized Controlled Trial. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Reporting of post-operative rehabilitation interventions for Total knee arthroplasty: a scoping review. [2022]

8. England pubmed.ncbi.nlm.nih.gov

2021 Mark Coventry Award: Use of a smartphone-based care platform after primary partial and total knee arthroplasty: a prospective randomized controlled trial. [2021]

9. England pubmed.ncbi.nlm.nih.gov

The effectiveness of the use of a digital activity coaching system in addition to a two-week home-based exercise program in patients after total knee arthroplasty: study protocol for a randomized controlled trial. [2018]

10. England pubmed.ncbi.nlm.nih.gov

Effects of a home-based, exergaming intervention on physical function and pain after total knee replacement in older adults: a randomised controlled trial. [2023]

11. England pubmed.ncbi.nlm.nih.gov

Effectiveness of remote exercise programs in reducing pain for patients with knee osteoarthritis: A systematic review of randomized trials. [2022]

12. Sweden pubmed.ncbi.nlm.nih.gov

Effectiveness of an interactive virtual telerehabilitation system in patients after total knee arthoplasty: a randomized controlled trial. [2022]

13. England pubmed.ncbi.nlm.nih.gov

A community-based exercise programme for older persons with knee pain using telemedicine. [2019]