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.
In this RCT, 66 adults with knee osteoarthritis will be assigned to either an exercise arm or mindful exercise arm. Both interventions will be delivered via videoconferencing in a group setting. In both groups, participants will receive a supervised session twice a week for 10 weeks. Participants will also receive a home program. During the study period, participants will be asked to remotely complete brief surveys every week and longer surveys on pain, function, mood, and other symptoms at baseline, week 5, week 10, week 16, and week 22. These surveys will be about pain, function, mood, and other symptoms. Participants will complete digital wearable-sensor based assessments at baseline and week 10. Participants will also be asked to complete brief surveys each week during the study. Feasibility of the intervention will be determined post-intervention by outcome measures such as recruitment rate, retention rate, and adherence.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
66
In this 10-week intervention, participants will be given strengthening exercises and neuromuscular re-education exercises.
In this 10-week intervention, mindfulness meditation will be integrated with strengthening and neuromuscular exercises recommended for knee osteoarthritis.
Boston University
Boston, Massachusetts, United States
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 study
Attendance
Proportion of sessions attended.
Time frame: Throughout the intervention period (over 10-weeks)
Retention Rate
Proportion of participants who complete patient-reported outcome surveys.
Time frame: Post-intervention visit (10-week)
Adverse and serious adverse events
\# of intervention related adverse or serious adverse events
Time frame: From first intervention session to week 22
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-week
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 weeks
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)
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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)
Pain Catastrophizing Scale
13-item self-report measure designed to assess catastrophic thinking related to pain among adults with or without chronic pain. Each item is rated on a 5-point scale: 0 (Not at all) to 4 (all the time).
Time frame: Baseline, 5-week, 10-week, 16-week, 22-week
Participant Global Impression of Change
Participant's rating of change in condition on a 15-point scale. Higher scores represent improvement and lower scores represent worsening or no change in symptoms.
Time frame: 5-week, 10-week, 16-week, 22-week
Tampa Scale of Kinesiophobia
17-item self-report checklist with a 4-point Likert scale (1 - Strongly disagree; 2 - Disagree; 3 - Agree; 4 - Strongly agree) to assess one's fear of movement. Scoring of items 4, 8, 12, and 16 must be reversed, where "strongly disagree" is 4 points, "disagree" is 3 points, "agree" is 2 points, and "strongly agree" is 1 point. Sum up the scores for all 17 items to obtain the total raw score, ranging from 17 to 68 points. Higher total scores indicate an increasing degree of kinesiophobia, with 17 indicating no kinesiophobia or negligible fear of movement and 68 representing the highest possible level of kinesiophobia.
Time frame: Baseline, 10-week, 22-week
Global Mindfulness Scale
13-item tool that assesses all five mindfulness factors: Allowance, Boundlessness, Open-Heartedness, Insight, and Presence.
Time frame: Baseline, 10-week, 22-week