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Behavioral Intervention

Mindful Exercise for Osteoarthritis (TEMPO-1B Trial)

N/A

Waitlist Available

Research Sponsored by Boston University Charles River Campus

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Meet National Institute for Health and Clinical Excellence clinical guidelines for knee osteoarthritis (i.e., age ≥ 50 years, presence of activity related pain, presence of morning knee stiffness ≤ 30 minutes)

Knee pain on most days for 3 months or more

Must not have

Previous knee osteotomy partial or total knee replacement in either knee

Currently receiving chemotherapy or radiation therapy for cancer except non-melanoma skin cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up throughout the recruitment process; up to 12 months from the start of the study

Awards & highlights

No Placebo-Only Group

Summary

"This trial will test if a 10-week telehealth mindful exercise program is feasible for people with knee osteoarthritis compared to a telehealth exercise program. Everything from recruitment to the intervention will be

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves mindful exercises and physical activity programs, potential side effects may include muscle soreness or strain. Mindfulness practice typically does not have side effects but could potentially cause emotional discomfort for some.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I have had knee pain most days for at least 3 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a knee surgery, including partial or total knee replacement.

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I am currently undergoing chemotherapy or radiation, except for non-melanoma skin cancer.

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I am planning to undergo major treatment for knee OA soon.

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I have or am currently receiving physical therapy for knee osteoarthritis.

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I have participated in mindfulness programs like Tai Chi or meditation recently.

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I have not had knee surgery in the last 6 months.

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I have had a hip or ankle joint replacement.

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I have a major surgery planned within the next 6 months.

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I have a neurological condition affecting my movement.

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I am not currently in a clinical trial for joint or muscle pain.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ throughout the recruitment process; up to 12 months from the start of the study

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~throughout the recruitment process; up to 12 months from the start of the study

This trial's timeline: 3 weeks for screening, Varies for treatment, and throughout the recruitment process; up to 12 months from the start of the study for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Attendance

Recruitment Rate

Retention Rate

+1 more

Secondary study objectives

Global Mindfulness Scale

Knee Injury and Osteoarthritis Outcome Score

Numeric Rating Scale - Nominated Activity

+5 more

Other study objectives

7-meter Walk Test

Arthritis Self Efficacy Scale

Cognitive and Affective Mindfulness Scale - Revised

+14 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Group TMX (Telehealth Exercise and Mindfulness)Experimental Treatment1 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 Control1 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.

0 / 12Eligibility criteria met