Group TMX (Telehealth Exercise and Mindfulness) for Osteoarthritis of the Knee

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Osteoarthritis of the KneeMindful Exercise program - Behavioral
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This is a parallel-arm mixed-methods randomized controlled trial to investigate the feasibility of telehealth delivered mindful exercise vs. usual exercise interventions for people with knee osteoarthritis.

Eligible Conditions
  • Osteoarthritis of the Knee

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

3 Primary · 35 Secondary · Reporting Duration: through the recruitment process, up to 3 months from the start of the study

12-week
Individual Interviews with 20 participants
Satisfaction Scale
Telehealth Usability Questionnaire
6-week, 12-week
Participant feedback survey
6-week, 12-week, 18-week
Participant global impression of change
Weekly for 12-weeks
Weekly Exercise log
baseline
Multidimensional Outcome Expectation for Exercise Scale
baseline, 12-week
6-minute walk test
7-meter walk test
Arthritis - Rapid Estimate of Adult Literacy in Medicine (A-REALM)
Arthritis Self Efficacy Scale
Chronic pain self-efficacy questionnaire
Conditioned Pain Modulation
Exercise Induced Hypoalgesia
Fear Avoidance Beliefs Questionnaire - Physical Activity
Isometric knee extensor force
Isometric knee flexor force
Mechanical Temporal Summation
Pain Catastrophizing
Pain
Patient-Reported Outcomes Measurement Information System - sleep disturbance
Pressure Pain Threshold
Sit to stand test
Stair climb test
Widespread Pain Index Symptom Severity Scale
eHealth Literacy Scale
baseline, 6-week, 12-week, 18-week
Cognitive and Affective Mindfulness Scale - Revised
Knee Injury and Osteoarthritis Outcome Score ADL Subscale
Knee Injury and Osteoarthritis Outcome Score Pain subscale
Pain, Enjoyment, General Activity scale
Patient Global Assessment of Osteoarthritis
Patient Health Questionnaire 8-item
baseline, weekly during the 12-weeks, 18-week
Numeric Rating Scale - nominated activity
post-intervention (at 12-weeks)
Attendance
post-intervention visit (at the end of 12-weeks)
Retention Rate
Month 3
Recruitment Rate
weekly for 12 weeks
Analgesic use
Weekly mindfulness log

Trial Safety

Trial Design

2 Treatment Groups

Group TX (Telehealth Exercise)
1 of 2
Group TMX (Telehealth Exercise and Mindfulness)
1 of 2

Active Control

Experimental Treatment

40 Total Participants · 2 Treatment Groups

Primary Treatment: Group TMX (Telehealth Exercise and Mindfulness) · No Placebo Group · N/A

Group TMX (Telehealth Exercise and Mindfulness)
Behavioral
Experimental Group · 1 Intervention: Mindful Exercise program · Intervention Types: Behavioral
Group TX (Telehealth Exercise)
Behavioral
ActiveComparator Group · 1 Intervention: Exercise · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: through the recruitment process, up to 3 months from the start of the study

Who is running the clinical trial?

Boston University Charles River CampusLead Sponsor
98 Previous Clinical Trials
11,054 Total Patients Enrolled
3 Trials studying Osteoarthritis of the Knee
222 Patients Enrolled for Osteoarthritis of the Knee
Deepak Kumar, PT, PhDPrincipal InvestigatorBoston University
2 Previous Clinical Trials
122 Total Patients Enrolled
2 Trials studying Osteoarthritis of the Knee
122 Patients Enrolled for Osteoarthritis of the Knee

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have average or more knee pain during the previous week.
You are able to attend the sessions.
You are able to understand and speak English at a sufficient level to understand the study procedures and informed consent.