Telehealth Exercise and Mindfulness for Pain in Osteoarthritis - Stage 1B
ConditionKnee Osteoarthritis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorBoston University Charles River Campus
About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Meet National Institute for Health and Clinical Excellence clinical guidelines for knee osteoarthritis (i.e., age ≥ 50 years, presence of activity related pain, no morning knee stiffness or presence of morning knee stiffness ≤ 30 minutes)
BMI<40
Knee pain on most days for 3 months or more
Average overall knee pain severity of ≥ 4 on an 11-point numeric rating scale over last 7 days, at least 2 weeks apart
Disqualifiers
Contraindications to exercise
Other pain in lower back or legs that is greater than knee pain
Received physical therapy treatment for knee OA in the past 6 months or currently receiving physical therapy
Received any mindfulness programs such as Tai Chi, meditation, etc. in the past 6 months or currently receiving such program
Trial design
Design model
Parallel
Treatments tested in this trial
Exercise Program
BehavioralIn this 10-week intervention, participants will be given strengthening exercises and neuromuscular re-education exercises.
Mindful Exercise
BehavioralIn this 10-week intervention, mindfulness meditation will be integrated with strengthening and neuromuscular exercises recommended for knee osteoarthritis.
Treatment groups
66 Participants
are divided into 2 treatment groupsGroup A: Group TX (Telehealth Exercise)Active comparator 1 intervention
Group B: Group TMX (Telehealth Exercise and Mindfulness)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Recruitment Rate
Proportion of participants that are recruited for the study
Time frame
Throughout the recruitment process; up to 12 months from the start of the study2
Attendance
Proportion of sessions attended.
Time frame
Throughout the intervention period (over 10-weeks)3
Retention Rate
Proportion of participants who complete patient-reported outcome surveys.
Time frame
Post-intervention visit (10-week)4
Adverse and serious adverse events
\# of intervention related adverse or serious adverse events
Time frame
From first intervention session to week 22Secondary outcomes
1
Knee Injury and Osteoarthritis Outcome Score
Patient-reported outcome for knee pain and disability; a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems.
Time frame
Baseline, 5-week, 10-week, 16-week, 22-week2
Numeric Rating Scale - Nominated Activity
Average rating of knee pain from 0-10, where 0 represents no pain and 10 represents worst pain imaginable, in the past week in a nominated activity selected at baseline.
Time frame
Weekly for 22 weeks3
Participant Feedback Survey
Custom scale measuring feedback on interventionists and interventions. Scores range from 0-4 (0 - Strongly Disagree, 1 - Disagree, 2 - Neither Agree no Disagree, 3 - Agree, and 4 - Strongly Agree).
Time frame
5-week, Post-intervention visit (10-week), Follow-up visit (22-week)4
Satisfaction Scale
Custom 4-item (0-10 Likert scale) to determine satisfaction with individual components of the intervention.
Time frame
Post-intervention visit (10-week), Follow-up visit (22-week)Other outcomes
1
7-meter Walk Test
Functional test that measures comfortable walking speed as participant walks for two laps of a 7-meter path for a total walking distance of 28-meters. Participants will performance this visit remotely at their home.
Time frame
Baseline,10-week2
Pain, Enjoyment, General Activity Scale
3-item scale assessing pain intensity and interference. The response range is 0-10; the score of Pain, Enjoyment, General Activity Scale is the mean of the three individual item scores. Higher scores represent worse pain and pain-related interference.
Time frame
Baseline, 5-week, 10-week, 16-week, 22-week3
Patient Global Assessment of Osteoarthritis
Participant's assessment of impact of osteoarthritis on their general health on a 0-100 mm scale. Higher scores represent higher impact of disease or worse global health.
Time frame
Baseline, 5-week, 10-week, 16-week, 22-week4
Treatment History
A survey that collects information about the treatments the individual has undertaken for their knee osteoarthritis
Time frame
Baseline, 5-week, 10-week, 16-week, 22-weekSponsors and contacts
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Source ClinicalTrials.gov