Boston University
Boston, Massachusetts, 02215, United States
Location status: Recruiting
NCT Number: NCT06684587
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.
Interested in participating?
Request Info50 year and older
All sexes
Interventional
Not applicable
Boston, Massachusetts, 02215, United States
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Throughout the recruitment process; up to 12 months from the start of the study
Proportion of participants that are recruited for the study
Time frame: Throughout the intervention period (over 10-weeks)
Proportion of sessions attended.
Time frame: Post-intervention visit (10-week)
Proportion of participants who complete patient-reported outcome surveys.
Time frame: From first intervention session to week 22
# of intervention related adverse or serious adverse events
Time frame: Baseline, 5-week, 10-week, 16-week, 22-week
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: Weekly for 22 weeks
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: 5-week, Post-intervention visit (10-week), Follow-up visit (22-week)
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: Post-intervention visit (10-week), Follow-up visit (22-week)
Custom 4-item (0-10 Likert scale) to determine satisfaction with individual components of the intervention.
Time frame: Baseline, 5-week, 10-week, 16-week, 22-week
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: 5-week, 10-week, 16-week, 22-week
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: Baseline, 10-week, 22-week
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
13-item tool that assesses all five mindfulness factors: Allowance, Boundlessness, Open-Heartedness, Insight, and Presence.
Time frame: Baseline,10-week
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, 5-week, 10-week, 16-week, 22-week
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-week
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-week
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-week
Self-reported outcome on severity of cognitive symptoms such as fatigue, trouble thinking or remembering, waking up tired, and other physical symptoms such as headache, dizziness, etc. Each symptom is scored on a 4-point scale where 0 indicates no problem and 3 indicates severe problem. Scores are calculated by summing items, with higher scores (out of a maximum score of 12) indicating greater symptom severity.
Time frame: Baseline, 5-week, 10-week, 22-week
7-item questionnaire for anxiety, with scoring from 0-3 on each item. A total score of 0-4 indicates minimal anxiety; 5-9 for mild anxiety; 10-14 for moderate anxiety; and 15-21 for severe anxiety
Time frame: Baseline, 10-week, 22-week
8-item scale assessing depression symptoms. Each question is scored from 0 to 3, where higher scores indicate higher frequency of experiencing depressive symptoms. The total score is the sum value of individual questions. Higher total scores indicate greater severity of depression.
Time frame: Baseline, 5-week, 10-week, 16-week, 22-week
Assess the number of painful, aching or stiffed joints.
Time frame: Baseline, 10-week, 22-week
Self-reported outcome assessing confidence in one's capacity to function despite pain. Scores range from 10 (very uncertain) to 100 (very certain). Higher scores indicate greater self-efficacy to manage osteoarthritis.
Time frame: Baseline,10-week
Self-reported outcome assessing how one's fear avoidance beliefs contributes to the cognitive/affective part of their knee pain. Each item is scored from 0 to 6. Total scores are the summation of each item scores. Higher total scores indicate greater fear of physical activity.
Time frame: Baseline,10-week
9-question survey tool that integrates individual-level biological and behavioral factors
Time frame: Baseline,10-week
Participants will be asked to wear a single inertial sensor that will be placed on their lower back for a period of 7 days. Mean daily walking in meters per second speed over 7 days will be extracted
Time frame: Baseline,10-week
Participants will be asked to wear a single inertial sensor that will be placed on their lower back for a period of 7 days. Standard deviation of daily walking speed in meters per second over 7 days will be extracted
Time frame: Weekly for 22-weeks
# of days and # of times/day of analgesic medication use for knee pain
Time frame: Weekly for 22-weeks
# of minutes of strengthening exercise per day of the week
Time frame: Weekly for 22-weeks
# of minutes of aerobic exercise per day of the week
Time frame: Weekly for 22-weeks (only for mindful exercise group)
# of minutes of mindfulness practice per day of the week
Contact information is provided by the study sponsor or research team.
Deepak Kumar, PT, PhD
CONTACT
Ehyun Kim, MS
CONTACT
Boston University Charles River Campus
Other
Telehealth Exercise and Mindfulness for Pain in Osteoarthritis: A Stage 1B Feasibility Study
Acronym: TEMPO-1B
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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