Exercise Programs for Knee Arthritis

(CaRE Trial)

Overseen By Gaupp

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Disqualifiers: Cardiovascular disease, Hypertension, Inflammatory disorders, others

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

Compensation: Varies

Number of Visits: 36

Duration: 12 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of different exercise programs for people with knee arthritis. One group will follow a regular exercise routine (Exercise without Rest), while the other group will include resting breaks during their sessions (Exercise with Rest). Researchers aim to determine if adding rest affects arthritis symptom management. This trial may suit individuals with knee osteoarthritis who experience their knee as the most painful joint and lead a sedentary lifestyle. As an unphased trial, it offers participants the chance to contribute to valuable research that could enhance arthritis management strategies.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have a history of cardiovascular disease or hypertension, it must be controlled by medication to participate.

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

Research has shown that exercise programs, with or without rest breaks, are generally safe for individuals with knee osteoarthritis. Studies indicate that exercising without rest breaks does not worsen knee osteoarthritis and is considered safe. For instance, one study found that regular exercise is safe and effective for knee osteoarthritis, with few side effects. Another study demonstrated that using technology to support exercise programs is both safe and beneficial for knee issues.

Exercise programs with rest breaks yield similar results. High-intensity exercise with rest breaks can enhance knee strength and quality of life without causing harm. In summary, both types of exercise programs are well-tolerated and have a good safety record according to past research. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these exercise programs for knee arthritis because they explore the impact of rest periods on exercise effectiveness. Unlike standard treatments like medication or physical therapy, which often focus on pain relief or general exercise, this trial specifically examines whether taking breaks during exercise sessions can enhance outcomes. The "Exercise With Rest" program integrates two 45-minute rest periods into a comprehensive workout, potentially optimizing recovery and reducing fatigue. This unique approach could lead to more personalized and effective exercise regimens for managing knee arthritis.

What evidence suggests that this trial's exercise programs could be effective for knee arthritis?

Research has shown that exercise therapy benefits people with knee osteoarthritis. In this trial, participants will join one of two exercise programs. The "Exercise With Rest" arm includes rest periods, which studies have found can lead to better recovery, less pain, and improved strength and quality of life. The "Exercise Without Rest" arm also helps reduce pain and improve symptoms. One study reported that 63.7% of reviews noted significant improvements with exercise therapy and few side effects. Both exercise programs are beneficial, but including rest periods might offer additional recovery benefits. ^{2 3 5 6 7}

Who Is on the Research Team?

Sara Piva

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

This trial is for people with knee osteoarthritis. It's designed to see if they can participate in two different exercise programs—one with rest breaks and one without. Specific eligibility details are not provided, so general health status may be considered.

Inclusion Criteria

I lead a sedentary lifestyle.

I am between 45 and 79 years old.

BMI range of 25 to 35 kg/m2

Exclusion Criteria

Contraindication to MRI

Medical condition or characteristic of the participant that could place the individual at increased risk or preclude them from complying with study procedures

Pregnant female

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo an exercise program 3 times a week for 12 weeks, with or without resting intervals

12 weeks

36 visits (in-person)

Assessment

Participants undergo assessments including gait analysis, MRI imaging, muscle strength tests, and questionnaires

1-2 weeks

Follow-up

Participants are monitored for adherence, retention, and safety of interventions

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Exercise without Rest
• Exercise with Rest

Trial Overview The study compares the feasibility of two exercise regimens for those with knee arthritis: a standard program versus one that includes rest periods. Participants will be randomly assigned to either group to evaluate which method works best.

How Is the Trial Designed?

Group I: Exercise With Rest Experimental Treatment 1 Intervention

Participants in this arm exercise 3 times a week for 12 weeks. Exercise program consists of warm-up, strengthening exercises of the lower major extremity muscle groups, and aerobic training using a treadmill. These sessions include two 45 minute rest periods between exercises and take about two and a half hours.

Group II: Exercise Without Rest Active Control 1 Intervention

Exercise without Rest

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

Carnegie Mellon University

Collaborator

Trials

80

Recruited

540,000+

Published Research Related to This Trial

The straight leg raise (SLR) exercise showed greater activation of the vastus medialis (VM) muscle compared to single leg stance and bilateral squat exercises, indicating its effectiveness in knee rehabilitation.

Among the weight-bearing exercises, step-up and unilateral leg press exercises resulted in the highest VM activation, suggesting they may be beneficial for progressing rehabilitation after SLR.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vastus medialis activation during knee extension exercises: evidence for exercise prescription. Bolgla, LA., Shaffer, SW., Malone, TR.[2022]

A randomized controlled trial involving 40 adults with knee osteoarthritis showed that adding mobilisation with movement to usual care significantly improved disability, pain, and function over six months, with a mean difference of 7.4 points in disability at six months.

Participants receiving mobilisation with movement reported better outcomes in all measured areas, except for knee mobility, indicating that this intervention can enhance overall patient satisfaction and functional abilities in managing knee osteoarthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long term efficacy of mobilisation with movement on pain and functional status in patients with knee osteoarthritis: a randomised clinical trial. Nigam, A., Satpute, KH., Hall, TM.[2022]

Recent systematic reviews and clinical trials indicate that progressive resistance training and aerobic exercise have a modest positive effect on strength, pain, and function in older adults and those with knee arthritis.

However, there is little evidence that exercise programs effectively prevent disability, suggesting that current exercise strategies may need to be revised or new approaches developed to better address disability outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise: necessary but not sufficient for improving function and preventing disability? Keysor, JJ., Brembs, A.[2011]

A study involving 80 patients with knee osteoarthritis showed that both home exercise programs significantly improved knee range of motion, muscle strength, and overall function, as measured by various health indices.

However, patients who received guidance from a physiotherapist experienced greater improvements compared to those who followed an exercise brochure alone, highlighting the added value of professional support in home exercise therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of effectiveness of the home exercise program and the home exercise program taught by physiotherapist in knee osteoarthritis. Yilmaz, M., Sahin, M., Algun, ZC.[2019]

Billie Jean King effectively managed her knee arthritis through a vigorous exercise program, demonstrating the potential benefits of physical activity for arthritis control.

Her experience highlights the importance of exercise as a therapeutic intervention for individuals with arthritis, suggesting that it can lead to improved joint function and overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

King vs Arthritis: Advantage, King. Duda, M.[2016]

A 12-week lower-body positive pressure (LBPP)-supported treadmill exercise program significantly reduced knee pain and improved joint function in 19 overweight patients with knee osteoarthritis, with benefits maintained for at least 6 months after the program ended.

Participants also retained gains in thigh muscle strength and reported continued improvements in quality of life, indicating that this exercise strategy could be effective for long-term management of knee OA symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Body Weight-Supported Exercise on Symptoms of Knee Osteoarthritis: A Follow-up Investigation. Peeler, J., Leiter, J., MacDonald, P.[2021]

Exercise is a safe and effective intervention for patients with knee osteoarthritis (OA), showing minimal adverse side effects, making it a suitable treatment option for managing the disease.

Obesity is identified as the most modifiable risk factor for knee OA, and the article discusses how weight loss and exercise can positively impact the condition, emphasizing the importance of these interventions in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diet and exercise for obese adults with knee osteoarthritis. Messier, SP.[2022]

A 5-week quadriceps-strengthening exercise program was feasible for an elderly man with severe dementia and knee osteoarthritis, indicating that such nonpharmacologic treatments can be implemented in this population.

While the exercise program improved the patient's sleep, the effectiveness on pain relief was inconclusive due to the inadequacy of the pain measurement tool for individuals with low cognitive functioning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of using quadriceps-strengthening exercise to improve pain and sleep in a severely demented elder with osteoarthritis - a case report. Tsai, PF., Richards, K., FitzRandolph, R.[2020]

A systematic review of 26 high-quality studies found that various strengthening exercise programs significantly improve pain relief, physical function, and quality of life for patients with knee osteoarthritis within a six-month period.

Combining strengthening exercises with other therapeutic activities, like coordination and balance training, further enhances these benefits, indicating a comprehensive approach may be more effective for managing knee osteoarthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Ottawa panel clinical practice guidelines for the management of knee osteoarthritis. Part two: strengthening exercise programs. Brosseau, L., Taki, J., Desjardins, B., et al.[2022]

Mind-body exercise programs, such as Hatha Yoga and Tai Chi, have been shown to effectively improve pain relief and physical function in patients with knee osteoarthritis, based on a systematic review of high-quality studies.

Hatha Yoga and Tai Chi Qigong received high grades for their effectiveness, with significant improvements noted in pain relief and quality of life, making them valuable non-traditional exercise options for managing knee osteoarthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Ottawa panel clinical practice guidelines for the management of knee osteoarthritis. Part one: introduction, and mind-body exercise programs. Brosseau, L., Taki, J., Desjardins, B., et al.[2022]

Therapeutic exercise is a safe and effective first-line treatment for patients with knee and hip osteoarthritis, with various types of exercises (like aerobic and strengthening) improving pain and function when performed at recommended dosages.

To enhance adherence to therapeutic exercise, strategies such as patient education and goal-setting are beneficial, especially since many patients face barriers to achieving the ideal exercise dosage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guidance for Implementing Best Practice Therapeutic Exercise for Patients With Knee and Hip Osteoarthritis: What Does the Current Evidence Base Tell Us? Holden, MA., Button, K., Collins, NJ., et al.[2022]

Exercise is an effective intervention for reducing pain and improving function in individuals with knee osteoarthritis, and it also provides pain relief for those with hip osteoarthritis, based on a review of multiple studies.

Despite the positive outcomes, there is a lack of clarity regarding the optimal frequency, dose, and duration of exercise for managing osteoarthritis, highlighting the need for more standardized research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Managing Hip and Knee Osteoarthritis with Exercise: What is the Best Prescription? Iversen, MD.[2021]

In a randomized controlled trial with 48 participants, both sensory-motor training and resistance training showed similar effectiveness in improving symptoms of knee osteoarthritis, as measured by the WOMAC index after 8 weeks.

Resistance training led to significant improvements in pain levels during movement and quality of life after 4 and 8 weeks, respectively, suggesting it may offer additional benefits over sensory-motor training in these specific areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sensory-motor training versus resistance training in the treatment of knee osteoarthritis: A randomized controlled trial. Kuş, G., Tarakçı, E., Razak Ozdincler, A., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12273085/

Effectiveness of exercise therapy in patients with knee ... This study aimed to assess the methodological quality of published systematic reviews of exercise therapy in knee osteoarthritis and summarise ...

2. eurjmedres.biomedcentral.com eurjmedres.biomedcentral.com/articles/10.1186/s40001-025-03083-4

Knee osteoarthritis rehabilitation: an integrated framework of ... The influence of exercise therapy on patients with KOA has been well researched, resulting in improvements in recovery, reduced pain, enhanced ...

3. mhealth.jmir.org mhealth.jmir.org/2024/1/e54356/

Efficacy of the mHealth-Based Exercise Intervention re.flex for ... This study aims to evaluate the efficacy of a 12-week fully automated app-based exercise intervention with and without a supporting knee brace on health- ...

4. frontiersin.org frontiersin.org/journals/physiology/articles/10.3389/fphys.2025.1561697/full

Effect of high-intensity training on improving knee flexion ... High-intensity exercise significantly improves knee flexion strength, leg press strength, and KOOS symptoms and QoL in knee osteoarthritis patients.

5. jospt.org jospt.org/doi/10.2519/jospt.2018.7877

Physical Activity and Exercise Therapy Benefit More Than ... Physical activity and exercise therapy not only improve symptoms and impairments of OA, but are also effective in preventing at least 35 chronic conditions.

6. jospt.org jospt.org/doi/10.2519/jospt.2016.6908

A Standardized “Rescue” Exercise Program for ... Having a predefined and standardized rescue exercise option appears beneficial, and did not result in further worsening of exacerbated knee OA ...

7. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2799405

Effect of Diet and Exercise on Knee Pain in Patients With ... This randomized clinical trial assesses the effect of a diet and exercise intervention vs an attention control condition on knee pain at ...