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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group TX (Telehealth Exercise) | Active Comparator | 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. |
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| Group TMX (Telehealth Exercise and Mindfulness) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise Program | Behavioral | In this 10-week intervention, participants will be given strengthening exercises and neuromuscular re-education exercises. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment Rate | Proportion of participants that are recruited for the study | Throughout the recruitment process; up to 12 months from the start of the study |
| Attendance | Proportion of sessions attended. | Throughout the intervention period (over 10-weeks) |
| Retention Rate | Proportion of participants who complete patient-reported outcome surveys. | Post-intervention visit (10-week) |
| Adverse and serious adverse events | # of intervention related adverse or serious adverse events | From first intervention session to week 22 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 5-week, 10-week, 16-week, 22-week |
| Numeric Rating Scale - Nominated Activity |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline,10-week |
| Pain, Enjoyment, General Activity Scale |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Deepak Kumar, PT, PhD | Contact | 617-358-3037 | kumard@bu.edu | |
| Ehyun Kim, MS | Contact | 617-358-8142 | kimawc@bu.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston University | Recruiting | Boston | Massachusetts | 02215 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39021877 | Background | Shah N, Morone N, Kim E, Ellis TD, Cohn E, LaValley MP, Kumar D. Telehealth mindful exercise for people with knee osteoarthritis: A decentralized feasibility randomized controlled trial. Osteoarthr Cartil Open. 2024 Jun 19;6(3):100494. doi: 10.1016/j.ocarto.2024.100494. eCollection 2024 Sep. |
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Requests will be considered on an individual basis
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D009043 | Motor Activity |
| D010146 | Pain |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D055070 | Resistance Training |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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Parallel-arm randomized controlled trial
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| Mindful Exercise | Behavioral | In this 10-week intervention, mindfulness meditation will be integrated with strengthening and neuromuscular exercises recommended for knee osteoarthritis. |
|
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. |
| 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). | 5-week, Post-intervention visit (10-week), Follow-up visit (22-week) |
| Satisfaction Scale | Custom 4-item (0-10 Likert scale) to determine satisfaction with individual components of the intervention. | 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). | 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. | 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. | Baseline, 10-week, 22-week |
| Global Mindfulness Scale | 13-item tool that assesses all five mindfulness factors: Allowance, Boundlessness, Open-Heartedness, Insight, and Presence. | Baseline, 10-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. |
| Baseline, 5-week, 10-week, 16-week, 22-week |
| 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. | Baseline, 5-week, 10-week, 16-week, 22-week |
| Treatment History | A survey that collects information about the treatments the individual has undertaken for their knee osteoarthritis | Baseline, 5-week, 10-week, 16-week, 22-week |
| Widespread Pain Index Symptom Severity Scale | 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. | Baseline, 5-week, 10-week, 16-week, 22-week |
| Generalized Anxiety Disorder 7-item | 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 | Baseline, 5-week, 10-week, 22-week |
| Patient Health Questionnaire 8-item | 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. | Baseline, 10-week, 22-week |
| Homunculus | Assess the number of painful, aching or stiffed joints. | Baseline, 5-week, 10-week, 16-week, 22-week |
| Arthritis Self Efficacy Scale | 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. | Baseline, 10-week, 22-week |
| Fear Avoidance Beliefs Questionnaire - Physical Activity | 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. | Baseline,10-week |
| Whole Person Health Index | 9-question survey tool that integrates individual-level biological and behavioral factors | Baseline,10-week |
| Daily life gait speed | 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 | Baseline,10-week |
| Daily life gait speed variability | 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 | Baseline,10-week |
| Weekly medication use | # of days and # of times/day of analgesic medication use for knee pain | Weekly for 22-weeks |
| Weekly strengthening exercise | # of minutes of strengthening exercise per day of the week | Weekly for 22-weeks |
| Weekly aerobic exercise | # of minutes of aerobic exercise per day of the week | Weekly for 22-weeks |
| Weekly mindfulness practice (only for mindful exercise group) | # of minutes of mindfulness practice per day of the week | Weekly for 22-weeks (only for mindful exercise group) |
| D012216 |
| Rheumatic Diseases |
| D001519 | Behavior |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |