Mindful Exercise for Osteoarthritis

(TEMPO-1B Trial)

Overseen By Ehyun Kim, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Boston University Charles River Campus

Must not be taking: Chemotherapy, Radiation, Corticosteroids

Disqualifiers: Rheumatoid arthritis, Knee surgery, Pregnancy, others

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

Compensation: Varies

Number of Visits: 36

Duration: 10 weeks

62 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this randomized controlled trial (RCT) is to test the feasibility of an 10-week telehealth mindful exercise intervention compared to a telehealth exercise only intervention for people with knee osteoarthritis (OA). This RCT will be fully digital with all recruitment, assessments, and intervention being conducted remotely.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. However, it does exclude those currently receiving chemotherapy or radiation therapy for cancer, except for non-melanoma skin cancer.

Is mindful exercise safe for people with osteoarthritis?

Research on yoga, a form of mindful exercise, suggests it is generally safe for people with osteoarthritis, with studies focusing on its effects on pain, function, and quality of life. Safety was a secondary outcome in a systematic review, indicating that it is considered when evaluating these programs. ^{1 2 3 4 5}

How is the Telehealth Exercise and Mindfulness treatment for osteoarthritis different from other treatments?

This treatment is unique because it combines exercise and mindfulness practices delivered through telehealth, allowing patients to manage osteoarthritis from home. Unlike traditional treatments that may require in-person visits, this approach offers flexibility and accessibility, especially beneficial during situations like the COVID-19 pandemic. ^{5 6 7 8 9}

What data supports the effectiveness of the treatment Telehealth Exercise and Mindfulness for osteoarthritis?

Research shows that mindfulness can enhance the response to exercise in people with knee osteoarthritis, and telehealth-delivered exercise programs are well-received and can improve pain and function. Mind-body exercises are also recommended for managing knee osteoarthritis, suggesting that combining mindfulness with telehealth exercise could be beneficial. ^{2 5 9 10 11}

Are You a Good Fit for This Trial?

This trial is for individuals with knee osteoarthritis. Participants will engage in the study remotely, meaning they can do it from home using digital tools like a computer or smartphone.

Inclusion Criteria

I am over 50, have knee pain related to activity, and stiffness in the morning lasts less than 30 minutes.

BMI < 40

Available for study duration

Exclusion Criteria

I haven't had steroid or hyaluronic acid knee injections in the last 3 months.

Pregnancy (self-report)

Suspected or known drugs or alcohol abuse

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a telehealth exercise or mindful exercise intervention twice a week for 10 weeks

10 weeks

20 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Remote surveys at weeks 16 and 22

What Are the Treatments Tested in This Trial?

Interventions

• Telehealth Exercise and Mindfulness

Trial Overview The study is testing two different 10-week programs delivered through telehealth: one combines exercise with mindfulness practices, and the other focuses on exercise only.

How Is the Trial Designed?

Group I: Group TMX (Telehealth Exercise and Mindfulness) Experimental Treatment 1 Intervention

Participants in this group will receive a group-based, supervised, integrated mindfulness and exercise program twice a week for 10 weeks along with a structured home program. Similar to the exercise intervention, these sessions will be delivered via Boston University HIPAA-compliant Zoom videoconferencing software.

Group II: Group TX (Telehealth Exercise) Active Control 1 Intervention

Participants in this group will receive a group-based, supervised exercise session twice a week for 10 weeks along with a structured home exercise program. These sessions will be delivered via Boston University HIPAA-compliant Zoom videoconferencing software.

Who Is Running the Clinical Trial?

Boston University Charles River Campus

Lead Sponsor

Trials

125

Recruited

14,100+

Published Research Related to This Trial

Patients who participated in telehealth for knee osteoarthritis found it to be easy, convenient, and flexible, leading to a positive perception of its acceptability, especially among those with prior exposure to telehealth.

Both telehealth and in-person participants reported similar benefits from the GLA:D® program, including reduced fear of pain, improved beliefs about exercise, and enhancements in pain and function, suggesting that telehealth can effectively provide high-quality care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Much better than I thought it was going to be": Telehealth delivered group-based education and exercise was perceived as acceptable among people with knee osteoarthritis. Ezzat, AM., Bell, E., Kemp, JL., 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]

In a study of 345 participants with knee osteoarthritis, telehealth-delivered exercise programs significantly improved pain and function, with increased arthritis self-efficacy and reduced fear of movement identified as key mediators of these improvements.

The combination of diet and exercise led to additional benefits, including weight loss, which further enhanced pain reduction and functional improvements compared to exercise alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How Does Exercise, With and Without Diet, Improve Pain and Function in Knee Osteoarthritis? A Secondary Analysis of a Randomized Controlled Trial Exploring Potential Mediators of Effects. Lawford, BJ., Hinman, RS., McManus, F., et al.[2023]

Yoga may help reduce pain, improve physical function, and decrease stiffness in individuals with knee osteoarthritis compared to both exercise and non-exercise control groups, based on a review of nine trials involving 640 participants aged 50-80 years.

However, the evidence is of very low quality and subject to potential bias, leading to only a weak recommendation for yoga as a treatment for knee osteoarthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Yoga for Osteoarthritis: a Systematic Review and Meta-analysis. Lauche, R., Hunter, DJ., Adams, J., et al.[2020]

Exercise therapy is effective in reducing pain and activity limitations in patients with knee osteoarthritis, and it is likely beneficial for hip osteoarthritis as well, highlighting its role as a non-invasive treatment option.

Combining exercise therapy with weight loss can further alleviate symptoms in overweight osteoarthritis patients, and new targeted exercise modalities are being developed to address specific activity limitations and joint instability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Exercise therapy in hip or knee osteoarthritis]. Dekker, J., Peter, W., van der Leeden, M., et al.[2011]

A systematic review of 23 studies involving 4,994 participants found that telephone-based interventions, often combined with educational materials, significantly reduced pain intensity and disability in patients with osteoarthritis and spinal pain compared to usual care.

However, adding face-to-face components to telephone interventions did not provide any additional benefits over standard care, indicating that simple telephone-based support may be sufficient for improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of telephone-based interventions for managing osteoarthritis and spinal pain: a systematic review and meta-analysis. O'Brien, KM., Hodder, RK., Wiggers, J., et al.[2022]

Citations

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

Mindfulness Is Associated With Treatment Response From Nonpharmacologic Exercise Interventions in Knee Osteoarthritis. [2021]

2. England pubmed.ncbi.nlm.nih.gov

"Much better than I thought it was going to be": Telehealth delivered group-based education and exercise was perceived as acceptable among people with knee osteoarthritis. [2022]

3. England 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. [2022]

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

How Does Exercise, With and Without Diet, Improve Pain and Function in Knee Osteoarthritis? A Secondary Analysis of a Randomized Controlled Trial Exploring Potential Mediators of Effects. [2023]

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

"Sounds a Bit Crazy, But It Was Almost More Personal:" A Qualitative Study of Patient and Clinician Experiences of Physical Therapist-Prescribed Exercise For Knee Osteoarthritis Via Skype. [2018]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Development of a mind body program for obese knee osteoarthritis patients with comorbid depression. [2023]

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

Yoga for Osteoarthritis: a Systematic Review and Meta-analysis. [2020]

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

The importance of dose in land-based supervised exercise for people with hip osteoarthritis. A systematic review and meta-analysis. [2018]

9. Canada pubmed.ncbi.nlm.nih.gov

An e-Learning Program for Physiotherapists to Manage Knee Osteoarthritis Via Telehealth During the COVID-19 Pandemic: Real-World Evaluation Study Using Registration and Survey Data. [2022]

10. Netherlands pubmed.ncbi.nlm.nih.gov

[Exercise therapy in hip or knee osteoarthritis]. [2011]

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

Effectiveness of telephone-based interventions for managing osteoarthritis and spinal pain: a systematic review and meta-analysis. [2022]