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Group TMX (Telehealth Exercise and Mindfulness) 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)

* BMI\<40

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

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.

Eligible Conditions

Osteoarthritis

Eligibility Criteria

Inclusion Criteria

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

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 / 7Eligibility criteria met