Healthy Living Program for Knee Replacement Recovery

Overseen By Ellen Wingard

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of South Carolina

Must not be taking: Anti-obesity medications

Disqualifiers: Mobility limiting comorbidity, Bariatric surgery, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 12 months

212 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether the PACE Weight Loss program aids recovery after knee replacement surgery. It aims to improve weight loss, physical activity, pain, and function by comparing it to a standard self-management program. Participants will either follow a personalized diet and activity plan with coaching or receive a self-management guide and regular calls. The trial seeks individuals who had knee replacement surgery in the last six months, have a BMI between 25-45, and can use a computer or smartphone to track progress. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance recovery after knee surgery.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking anti-obesity medications.

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

Research has shown that weight loss programs like the PACE Weight Loss Program are generally safe for most people. Studies have found that these programs can help participants lose significant weight over time without serious side effects. Participants typically receive personalized diet and exercise plans, along with coaching support, to help them develop healthier habits. Some individuals might experience mild discomfort, such as hunger or tiredness, but these feelings are usually temporary and manageable. Overall, the PACE program is considered well-tolerated and aims to support healthy weight loss and recovery after knee replacement. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the PACE Weight Loss Program because it takes a personalized approach to aid knee replacement recovery by incorporating tailored diet, activity, and weight loss goals. Unlike standard rehabilitation therapies that might focus primarily on physical therapy, the PACE program emphasizes self-monitoring and behavioral changes, supported by regular coaching calls over a full year. This comprehensive, long-term support is designed to empower patients to take charge of their recovery, potentially leading to better outcomes than traditional methods alone.

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

Research has shown that the PACE Weight Loss program, which participants in this trial may receive, can help adults lose significant weight after knee replacement surgery. Early evidence suggests that starting this program about 12 weeks post-surgery results in more weight loss by 26 weeks than starting later. The program sets personalized diet and activity goals to increase physical activity. Since many patients gain weight after knee surgery, this program aims to prevent that. Losing weight may also reduce knee pain and improve knee function. ^{1 2 3 6 7}

Who Is on the Research Team?

Christine Pellegrini, Ph.D.

Principal Investigator

University of South Carolina

Are You a Good Fit for This Trial?

This trial is for adults who've had knee replacement surgery within the past 6 months, have a BMI of 27-45 kg/m2, and can access the internet with a compatible device. They should be willing to attend four in-person assessments and speak English. It's not for those in other weight loss programs, planning major relocations or additional knee surgeries soon, or with conditions that limit mobility like spinal stenosis.

Inclusion Criteria

I had a knee replacement less than 12 weeks ago.

Be willing to attend 4 in-person assessments

My BMI is between 27 and 45.

Exclusion Criteria

I am having both knees replaced at the same time or plan to have the other knee replaced soon.

I am enrolled in a weight loss program.

Are planning to relocate out of the Columbia or Greenville, SC areas in the next 18 months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to either a weight loss program or a chronic disease self-management program, with coaching calls weekly during months 1-4, biweekly during months 5-6, and monthly during months 7-12.

12 months

Weekly calls (months 1-4), biweekly calls (months 5-6), monthly calls (months 7-12)

Follow-up

Participants continue to receive monthly calls and are monitored for changes in weight, physical activity, pain, and function.

6 months

Monthly calls

What Are the Treatments Tested in This Trial?

Interventions

• Chronic Disease Self-Management
• PACE Weight Loss program

Trial Overview The study compares two programs: PACE Weight Loss program aimed at improving weight loss and physical activity post-knee replacement versus Chronic Disease Self-Management program. The goal is to see which one leads to better outcomes in terms of weight loss, pain relief, improved function, and cost-effectiveness.

How Is the Trial Designed?

Group I: PACE Weight Loss Program Experimental Treatment 1 Intervention

Participants randomized to this arm will receive personalized diet, activity, and weight loss goals as well as tools to self-monitor behaviors and weight. To facilitate changes, participants will receive coaching calls weekly during months 1-4, biweekly during months 5-6, and monthly during months 7-12.

Group II: Chronic Disease Self-Management Program Placebo Group 1 Intervention

Participants randomized to this arm will receive a chronic disease self-management program including a self-management book. Participants will receive regular calls weekly during months 1-4, biweekly during months 5-6, and monthly during months 7-12.

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

In a study of 66 total knee replacements in morbidly obese women, only 57% achieved excellent or good results, compared to 86% in nonobese women, indicating that while knee replacement is safe for morbidly obese patients, the outcomes are less favorable than for nonobese patients.

The study found no significant weight loss in morbidly obese patients after knee replacement surgery, suggesting that the procedure should not be viewed as a method for facilitating weight loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Knee replacement in morbidly obese women. Pritchett, JW., Bortel, DT.[2009]

An 8-week low-energy diet before total knee replacement led to an average weight loss of 10.7 kg in patients, which was maintained one year after surgery, indicating the feasibility and safety of preoperative weight loss interventions.

While both groups showed improvements in quality of life and knee function after surgery, there were no statistically significant differences between the diet and control groups, suggesting that while weight loss is beneficial, it may not directly translate to better functional outcomes compared to standard care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Weight Loss Intervention Before Total Knee Replacement: A 12-Month Randomized Controlled Trial. Liljensøe, A., Laursen, JO., Bliddal, H., et al.[2022]

A multi-component dietary weight loss program, including a ketogenic very low calorie diet and video consultations, was well-received by 24 patients with knee osteoarthritis, highlighting its ease of use and convenience as key factors for adherence.

Support from dietitians and the program's holistic approach, which included educational resources and exercise, were crucial for participants' success, leading to improved knee pain and function over the 6-month period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"It's the single best thing I've done in the last 10 years": a qualitative study exploring patient and dietitian experiences with, and perceptions of, a multi-component dietary weight loss program for knee osteoarthritis. Lawford, BJ., Bennell, KL., Jones, SE., et al.[2021]

A multicenter trial involving 422 participants showed that a post-acute group exercise program after total knee replacement (TKR) did not lead to significantly better outcomes in knee pain or activity limitations compared to usual care over 12 months.

Despite both groups experiencing improvements in pain and activity limitations, many participants still faced notable physical performance deficits a year after surgery, indicating that additional interventions may be needed to enhance recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Post-Acute Rehabilitation After Total Knee Replacement: A Multicenter Randomized Clinical Trial Comparing Long-Term Outcomes. Fransen, M., Nairn, L., Bridgett, L., et al.[2018]

Patients scheduled for knee replacement prefer weight loss programs that begin before surgery, last at least 6 months, and include both diet and exercise components, highlighting the importance of early intervention.

The study revealed that patients are motivated to lose weight primarily for physical appearance and to alleviate knee symptoms, and they find strategies like joining formal programs and self-monitoring effective in their weight loss efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preferences and motivation for weight loss among knee replacement patients: implications for a patient-centered weight loss intervention. Pellegrini, CA., Ledford, G., Hoffman, SA., et al.[2019]

In a study of 100 patients undergoing total hip or knee replacement, it was found that most patients gained weight post-surgery, regardless of whether they had hip or knee replacements.

The results indicate that successful joint replacement surgery does not lead to weight loss, suggesting that obesity should be treated as a separate health issue rather than solely a consequence of joint disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of lower-extremity total joint replacement for arthritis on obesity. Heisel, C., Silva, M., dela Rosa, MA., et al.[2022]

In a study of 4,624 participants from the Look AHEAD trial, those who underwent total knee arthroplasty (TKA) while on an intensive lifestyle intervention (ILI) maintained significant weight loss compared to those receiving standard diabetes support, both before and after surgery.

The analysis showed that TKA did not negatively impact the ability of participants to adhere to weight loss goals, indicating that patients with obesity can continue to lose weight after surgery while on a structured weight loss program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Association of Total Knee Arthroplasty With Weight Loss in the Look AHEAD (Action for Health in Diabetes) Clinical Trial. Mihalko, WM., Johnson, KC., Neiberg, RH., et al.[2023]

A seven-year follow-up study of 49 patients who underwent total knee arthroplasty (TKA) found that those who participated in a preoperative weight loss program could not maintain their weight loss long-term, gaining an average of 3.1 kg more than the control group.

Despite the inability to maintain weight loss, both groups showed significant improvements in pain, knee function, and health-related quality of life after TKA, indicating that weight loss prior to surgery may still have short-term benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term results after weight loss intervention in knee arthroplasty patients with obesity. Thomasen, A., Mechlenburg, I., Laursen, JO., et al.[2022]

Participants with knee osteoarthritis who completed a 6-month multicomponent weight loss program reported positive experiences in maintaining their weight loss 6 months later, highlighting the effectiveness of the program.

The program, which included a very low-calorie diet, exercise, and support from dietitians and physiotherapists, empowered participants to manage their weight, although challenges such as loss of accountability and returning to old habits were noted.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

'The fact that I know I can do it is quite a motivator now': a qualitative study exploring experiences maintaining weight loss 6 months after completing a weight loss programme for knee osteoarthritis. Lawford, B., Hinman, RS., Jones, S., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6335652/

Comparison of a Patient-Centered Weight Loss Program ... Preliminary evidence suggesting that initiating a program 12 weeks after surgery produces greater weight losses at 26 weeks compared to a program starting ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05190666?cond=Obesity&term=weight-loss%20program;%20weight%20management%20program&aggFilters=funderType:nih%20fed,status:rec&rank=9

NCT05190666 | Healthy Living After Knee Replacement The purpose of this study is to examine if a weight loss program designed for adults after knee replacement improves weight loss , physical activity, pain, and ...

3. withpower.com withpower.com/trial/phase-overweight-2022-a3d9a

Healthy Living Program for Knee Replacement Recovery The purpose of this study is to examine if a weight loss program designed for adults after knee replacement improves weight loss, physical activity, pain, ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5540525/

Preferences and motivation for weight loss among knee ... Zeni and colleagues [14] estimate that 66% of patients actually gain weight by 2 years after surgery. Weight loss programs for adults with knee ...

5. trial.medpath.com trial.medpath.com/clinical-trial/514b4649d2b8177d/nct02728661-patient-centered-weight-loss-program-knee-replacement

Patient-Centered Weight Loss Program for Knee Replacement ... Yet, 66% of patients actually gain weight by 2 years after surgery. Patients undergoing TKR not only face unique barriers (i.e., pain, mobility limitations, ...

6. sc.edu sc.edu/study/colleges_schools/public_health/research/research_areas/exercise_science/tech_behavioral_intervention/current_projects/

Current Projects - Arnold School of Public Health The purpose of this project is to evaluate the effectiveness of the PACE weight loss program in adults after TKR in a fully-powered two-arm randomized ...

7. journals.sagepub.com journals.sagepub.com/doi/full/10.1177/1457496919883812

Weight Loss Intervention Before Total Knee Replacement The average weight loss after 8-week preoperative intervention was 10.7 kg and consisted of a 6.7 kg reduction in fat mass. One year after total ...