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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine which additional features in an online exercise program help individuals who have undergone knee replacement surgery become more active. Participants will explore various combinations of tools, such as 'Hear from Others' videos, personalized feedback, phone coaching, and progress updates to doctors. The goal is to identify which options most effectively improve physical activity, reduce pain, and enhance physical function over time. It is suitable for those who had knee replacement surgery over a year ago, have internet access, and currently engage in less than 60 minutes of moderate exercise per week. As an unphased trial, this study provides participants the chance to explore innovative tools that could enhance their recovery journey.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that home-based exercise programs, such as the Energize Online Program, are generally safe for individuals after knee replacement surgery. Studies comparing these programs to regular physiotherapy found that participants managed them well, with no serious safety issues reported. This suggests that the online exercise program, which includes phone coaching and feedback, is safe to try. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores new ways to enhance recovery after knee replacement surgery by combining an online exercise program with personalized support. Unlike traditional physical therapy, which often requires in-person visits, this approach offers flexibility through online access, making it easier for patients to stick with their exercise routine. The trial also adds unique elements like 'Hear from Others' videos, which provide motivational stories from other patients, and individualized feedback, ensuring that each patient's progress is closely monitored and adjusted as needed. By involving phone coaching and progress reports to healthcare providers, this trial aims to create a comprehensive support system that could lead to better outcomes and faster recovery times for patients.

What evidence suggests that this trial's treatments could be effective for knee replacement patients?

Research has shown that online exercise programs like the Energize! program can significantly increase physical activity in people after knee replacement surgery. This trial will evaluate various combinations of the Energize! program features. Some participants will receive the Energize! program alone, while others will receive additional features such as phone coaching, progress updates for doctors, and personalized feedback. Studies have found that these programs help participants engage in more moderate to vigorous exercise, which is important for meeting recommended activity levels. Participants also often experience less pain and improved physical function. Overall, the Energize! program and its features hold promise for helping people stay active and recover well after knee replacement surgery. ^{2 5 6 7 8}

Who Is on the Research Team?

Jessica Unick, PhD

Principal Investigator

The Miriam Hospital

Christine Pellegrini, PhD

Principal Investigator

University of South Carolina

Are You a Good Fit for This Trial?

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.

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

Self-report engaging in less than 60 minutes/week of moderate-intensity physical activity

Exclusion Criteria

Are participating in a structured weight loss or physical activity program

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

Live outside of the continental U.S

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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 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 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]

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]

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]

Citations

1. acrabstracts.org acrabstracts.org/abstract/preliminary-effects-of-a-fully-remote-online-physical-activity-program-following-knee-replacement/

Preliminary Effects of a Fully-Remote Online Physical ... Therefore, this study conducted entirely remotely, examined the effects of a 12-week fully automated online physical activity program (Energize!) on ActiGraph- ...

2. trialx.com trialx.com/clinical-trials/listings/266858/the-energize-study-for-adults-with-knee-replacement/?&geo_lat=34.0004&geo_lng=-81.0334&radius=10&place=Columbia&user_country=United%20States

The Energize! Study for Adults With Knee Replacement The purpose is to examine the effects of an online physical activity program on moderate to vigorous intensity physical activity, pain, and ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5498982/

study protocol for a randomized controlled trial The objective of this study is to determine the effectiveness of an activity coaching system in addition to a home-based exercise program after a TKA compared ...

4. withpower.com withpower.com/trial/remote-exercise-program-for-knee-replacement-05755

Remote Exercise Program for Knee Replacement The purpose of this study is to identify which supplemental intervention components added to an online exercise program contribute to the greatest increases ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04761367

NCT04761367 | Exercise Program After Total Hip and ... It is aimed at evaluating the efficacy and safety of an exercise program specifically designed for improving physical function and QoL in people who had ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06768762

Study Details | NCT06768762 | Optimizing a Remote ... The purpose of this study is to identify which supplemental intervention components added to an online exercise program contribute to the greatest increases ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8202539/

Efficacy and safety of a self-developed home-based ... This randomized controlled study compared standard supervised physiotherapy (SPT) with a self-developed, home-based, enhanced knee flexion exercise program ...

8. josr-online.biomedcentral.com josr-online.biomedcentral.com/articles/10.1186/s13018-021-02516-0

Efficacy and safety of a self-developed home-based enhanced ... This randomized controlled study compared standard supervised physiotherapy (SPT) with a self-developed, home-based, enhanced knee flexion exercise program.