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?

This trial aims to evaluate the effectiveness of a 10-week mindful exercise program for individuals with knee osteoarthritis (OA). Participants will join one of two groups: one combining mindfulness with exercise (Telehealth Exercise and Mindfulness) and another focusing on exercise alone. All recruitment and sessions occur online. Individuals experiencing knee pain most days for at least three months and who have not recently undergone physical therapy may qualify. As an unphased trial, this study provides a unique opportunity to explore innovative approaches to managing knee OA from home.

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.

What prior data suggests that this mindful exercise intervention is safe for people with knee osteoarthritis?

Research has shown that mindful exercises through telehealth are safe for people with knee osteoarthritis (OA). In an 8-week study, participants with knee OA performed these exercises in groups over a video call and found them manageable.

Mindfulness, often included in yoga, is generally safe for individuals with osteoarthritis. It helps reduce pain without causing harm. This method has been tested and proven safe, providing a reliable way to manage symptoms in people with knee OA. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Mindful Exercise for Osteoarthritis treatment because it blends telehealth exercise with mindfulness, offering a holistic approach to managing osteoarthritis. Unlike traditional treatments that focus solely on physical therapy or medications, this method integrates mental well-being with physical activity. The telehealth format makes it accessible and convenient, allowing participants to engage in structured sessions from home. This innovative combination could potentially enhance patient outcomes by addressing both mental and physical aspects of osteoarthritis.

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

This trial will compare two approaches for managing knee osteoarthritis (OA): a combined telehealth exercise and mindfulness program, and a telehealth exercise program alone. Research has shown that combining online exercise sessions with mindfulness can help people with knee OA by easing pain management and enhancing movement. One study found that adding mindfulness to exercise routines worked better than exercise alone. Participants in this trial will experience these online programs, which have been reported as safe and easy to use, suggesting they could be effective options for managing knee OA symptoms. ^{1 2 4 6 7}

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

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11254171/

Telehealth mindful exercise for people with knee ... An 8-week telehealth, group-based, mindful exercise intervention was safe for people with knee OA. Our decentralized approach was feasible in terms of ...

2. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/16/NCT05524116/Prot_SAP_000.pdf

Telehealth exercise and mindfulness for pain in ... traditional exercise treatments may increase the effectiveness of exercise alone. ... MOOES = Modified Outcomes of Exercise Expectations ...

3. liebertpub.com liebertpub.com/doi/10.1177/27683605251364715?doi=10.1177/27683605251364715

Participant Experiences in Using a Telehealth Mindful ... Objective: To explore the acceptability of an 8-week, telehealth, group-based, mindful exercise intervention in individuals with knee osteoarthritis (OA).

4. bmcmusculoskeletdisord.biomedcentral.com bmcmusculoskeletdisord.biomedcentral.com/articles/10.1186/s12891-023-07131-0

protocol for the Better Hip randomised controlled trial | BMC ... The primary aim of this study is to determine the effectiveness of a telehealth-delivered clinician-supported exercise and weight loss program (Better Hip)

5. jmir.org jmir.org/2024/1/e55576/

Effectiveness of Internet-Based Telehealth Programs in ... The meta-analysis provides moderate-quality evidence that IBTH programs have a beneficial effect on improving function, relieving pain, and improving self- ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39021877/

Telehealth mindful exercise for people with knee osteoarthritis Conclusion: An 8-week telehealth, group-based, mindful exercise intervention was safe for people with knee OA. Our decentralized approach was ...

7. withpower.com withpower.com/trial/phase-osteoarthritis-knee-1-2025-3b421

Mindful Exercise for Osteoarthritis (TEMPO-1B Trial) 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, ...