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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.
In this RCT, the feasibility of an 8-week telehealth mindful exercise intervention compared to an 8-week telehealth exercise only intervention for people with knee osteoarthritis (OA) will be assessed. Forty adults with knee OA will be assigned to either a mindful exercise arm OR exercise arm. Both interventions will be delivered via real-time videoconferencing in a group setting (n=8-10 per group). All participants will be administered questionnaires for self-reported symptoms, mood, quality of life, etc. throughout the study period. Participants will be given the choice to opt in for in-person data collection visits wherein their physical function, muscle strength, sensitivity to painful stimuli, and brain function will be assessed before and at the end of the interventions. At the end of the 8-week interventions, 10 participants will be purposively sampled from each arm (n=20 total) for individual interviews to determine acceptability of the telehealth interventions. 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 supervised and group-based exercise program once a week for 8 weeks via telehealth. |
|
| Group TMX (Telehealth Exercise and Mindfulness) | Experimental | Participants in this group will receive a supervised, group-based integrated mindfulness and exercise program once a week for 8 weeks via telehealth. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindful Exercise program | Behavioral | In this 8-week intervention, components of Mindful Based Stress Reduction Program will be integrated with strengthening and neuromuscular exercises recommended for knee osteoarthritis. The goal of this program is to train participants how to be mindful during their exercises. |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment | Number of participants that are randomized for the study | through the recruitment process, up to 6 months from the start of the study |
| Attendance | Proportion of sessions attended | post-intervention (at 8-weeks) |
| Retention Rate | Proportion of participants who complete patient-reported outcome surveys | post-intervention visit (at the end of 8-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) | 8-week |
| Satisfaction Scale | Custom 4-item (0-10 scale) to determine satisfaction with individual components of the intervention (i.e.,, exercise, mindfulness, telehealth, and overall satisfaction). There are 4 items and each item is scored separately. Higher scores for each item mean greater satisfaction for that dimension. | 8-week |
| 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, 8-week, 14-week |
| Pain, Enjoyment, General Activity Scale |
| Measure | Description | Time Frame |
|---|---|---|
| Arthritis - Rapid Estimate of Adult Literacy in Medicine (A-REALM) | 66-word recognition adult health literacy test. Each correct pronunciation of word is scored as 1. The total score is classified into 1 to 4 reading grade levels where higher scores (61-66) represent ninth grade and above reading level | baseline |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Deepak Kumar, PT, PhD | Boston University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Movement and Applied Imaging Lab, Boston University | Boston | Massachusetts | 02215 | United States |
Requests will be considered on an individual basis
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A total of 45 participants were enrolled (i.e., signed the consent form) and 40 of these were randomized to Group TX (n=19) or Group TMX (n=21).
Five participants withdrew from the study prior to randomization due to work schedule changes (n=2), severe back pain (n=1), family emergency (n=1), and lack of motivation (n=1).
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| ID | Title | Description |
|---|---|---|
| FG000 | Group TX (Telehealth Exercise) | Participants in this group will receive a supervised and group-based exercise program once a week for 8 weeks via telehealth. Exercise: In this 8-week intervention, participants will be given recommended strengthening and neuromuscular exercises for knee osteoarthritis. Participants in both the intervention and control group will receive these exercises. |
| FG001 | Group TMX (Telehealth Exercise and Mindfulness) | Participants in this group will receive a supervised, group-based integrated mindfulness and exercise program once a week for 8 weeks via telehealth. Mindful Exercise program: In this 8-week intervention, components of Mindful Based Stress Reduction Program will be integrated with strengthening and neuromuscular exercises recommended for knee osteoarthritis. The goal of this program is to train participants how to be mindful during their exercises. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline to Postintervention (Week 8) |
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| |||||||||||||||||||||
| Week 8 to Follow-up (Week 14) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Group TX (Telehealth Exercise) | Participants in this group will receive a supervised and group-based exercise program once a week for 8 weeks via telehealth. Exercise: In this 8-week intervention, participants will be given recommended strengthening and neuromuscular exercises for knee osteoarthritis. Participants in both the intervention and control group will receive these exercises. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Recruitment | Number of participants that are randomized for the study | A total of 40 randomized over 6 months (Oct 2022 - March 2023) | Posted | Count of Participants | Participants | through the recruitment process, up to 6 months from the start of the study |
|
14-weeks
The adverse events were self-reported by participants during the course of the study. No serious adverse events were reported by participants in either groups.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group TX (Telehealth Exercise) | Participants in this group will receive a supervised and group-based exercise program once a week for 8 weeks via telehealth. Exercise: In this 8-week intervention, participants will be given recommended strengthening and neuromuscular exercises for knee osteoarthritis. Participants in both the intervention and control group will receive these exercises. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Exacerbation of knee pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | There were four reports of adverse events potentially related to the study in TX group and 0 in the TMX group. These adverse events were related to exacerbation of knee pain. The remaining adverse events were unrelated to the study. |
There are limitations to consider while interpreting the findings of our study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Deepak Kumar | Boston University | 3026901455 | kumard@bu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 15, 2023 | Nov 15, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 5, 2023 | Oct 29, 2023 | ICF_001.pdf |
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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 |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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Parallel-arm randomized controlled trial
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For some of the outcomes that are not patient-reported, researchers collecting the at the post-intervention visit timepoint will be blinded to group allocation.
|
| Exercise | Behavioral | In this 8-week intervention, participants will be given recommended strengthening and neuromuscular exercises for knee osteoarthritis. Participants in both the intervention and control group will receive these exercises. |
|
Assesses Pain Intensity and Interference. the response range is 0-10; the PEG scale score is the mean of the three individual item scores. Higher scores represent worse pain. |
| baseline, 8-week, 14-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 | baseline, 8-week, 14-week |
| Participant Global Impression of Change | participant's rating of change in condition on a 14-point scale ranging from "a very great deal worse" to "a very great deal better". Values range from -7 to +7 (excluding 0). Score >=1 represent improvement and scores <= -1 represent worsening. | 8-week, 14-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, 8-week, 14-week |
| Pain Catastrophizing Scale | 3-item scale which measures of catastrophizing related to pain. Each item is rated on a 5-point scale: 0 (Not at all) to 4 (all the time). | baseline, 8-week |
| Widespread Pain Index Symptom Severity Scale | self-report 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, 8-week |
| Pain DETECT | self-report measure on presence of neuropathic pain. each question is scored from 0 to 5 where higher scores indicate higher gradation of pain. The final score is between -1 and 38 and a score of 19 and higher indicates higher likelihood of neuropathic pain | baseline, 8-week |
| Patient Health Questionnaire 8-item | 8-item questionnaire assessing depression symptoms. Each question is scored from 0 to 3 where higher scores indicate higher frequency of experiencing depressive symptoms. Total score is the sum of individual item scores. Score range is 0-24. Higher total scores indicate greater severity of depression | baseline, 8-week, 14-week |
| Cognitive and Affective Mindfulness Scale - Revised | 12-item scale on dispositional mindfulness. Items are rated on a 4-point Likert scale from 1 (rarely/not at all) to 4 (almost always). Scores on the scale are summed. Higher scores reflect greater mindfulness. | baseline, 8-week, 14-week |
| Fear Avoidance Beliefs Questionnaire - Physical Activity | 4-item questionnaire to determine 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 summation of each item scores. Range is 0-24. Higher total scores indicate greater fear of physical activity | baseline, 8-week |
| Arthritis Self Efficacy Scale | Questionnaire to assess confidence in one's capacity to function despite pain. Each item in the questionnaire is scored on a 1-10 scale. It provides three subscales of pain, function, and other symptoms calculated as average of items contributing to that subscale. Range for each subscale is 1-10. Higher scores indicate greater self-efficacy to manage osteoarthritis. | baseline, 8-week |
| Chronic Pain Self-efficacy Questionnaire | Measures three domains of pain self-efficacy: pain management, physical functioning, and coping with symptoms. Each item is scored on a scale of 0 (very uncertain) to 100 (very certain). Score for each domain is the average of all items contributing to that domain. Higher total scores indicate greater self-efficacy to manage one's chronic pain. | baseline, 8-week |
| Sit to Stand Test [OPTIONAL IN-PERSON VISIT] |
functional test that measures the time taken to sit and stand from chair five times |
| baseline, 8-week |
| 6-minute Walk Test [OPTIONAL IN-PERSON VISIT] | functional test that measures the maximal distance covered while walking at fast-pace for six minutes | baseline, 8-week |
| 7-meter Walk Test [OPTIONAL IN-PERSON VISIT] | functional test that measures comfortable walking speed as participant walks back and forth over 7 meters twice | baseline, 8-week |
| Stair Climb Test [OPTIONAL IN-PERSON VISIT] | functional test that measures the time taken to ascend and descend a flight of stairs | baseline, 8-week |
| Pressure Pain Threshold [OPTIONAL IN-PERSON VISIT] | a test of pain sensitivity | baseline, 8-week |
| Mechanical Temporal Summation [OPTIONAL IN-PERSON VISIT] | a test of central pain sensitization | baseline, 8-week |
| Conditioned Pain Modulation [OPTIONAL IN-PERSON VISIT] | a test of descending pain modulation | baseline, 8-week |
| Exercise Induced Hypoalgesia [OPTIONAL IN-PERSON VISIT] | a test of change in pain sensitivity after a bout of exercise | baseline, 8-week |
| Isometric Knee Extensor Force [OPTIONAL IN-PERSON VISIT] | knee extensor isometric muscle strength | baseline, 8-week |
| Isometric Knee Flexor Force [OPTIONAL IN-PERSON VISIT] | knee flexor isometric muscle strength | baseline, 8-week |
| Telehealth Usability Questionnaire | scale evaluating the usability and satisfaction of telehealth implementation and services. Each item is rated on a seven-point Likert scale, with a rating of one indicating disagree and a rating of seven indicating agree; higher ratings indicate better system usability | 8-week |
| Weekly Log | log of minutes and days spent doing strengthening exercises, aerobic exercises, and mindfulness practice (mindfulness practice only applicable to people in the TMX group). Survey also includes log of oral analgesic use. | Weekly for 14-weeks |
| Heal Treatment Expectancy Survey - Short Form | 6-item survey assessing participant's attitude and expectations of the intervention measured on a 5-point likert scale. higher scores indicate more positive attitude and expectations for the treatment | baseline |
| Treatment History | a survey that collects information about the treatments the individual has undertaken for their knee osteoarthritis | baseline, week 8, week 14 |
| eHealth Literacy Scale | 8-item scale measuring one's perceived ability and comfort with accessing digital services for health information. each item is rated on a 5-point likert scale. total scores are summed. higher scores indicate greater perceived skills at using online health information to help solve health problems | baseline |
| hernia surgery |
|
| NOT COMPLETED |
|
|
| BG001 | Group TMX (Telehealth Exercise and Mindfulness) | Participants in this group will receive a supervised, group-based integrated mindfulness and exercise program once a week for 8 weeks via telehealth. Mindful Exercise program: In this 8-week intervention, components of Mindful Based Stress Reduction Program will be integrated with strengthening and neuromuscular exercises recommended for knee osteoarthritis. The goal of this program is to train participants how to be mindful during their exercises. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Education | Count of Participants | Participants |
|
| Annual income | Count of Participants | Participants |
|
| Marital Status | Count of Participants | Participants |
|
Participants in this group will receive a supervised, group-based integrated mindfulness and exercise program once a week for 8 weeks via telehealth. Mindful Exercise program: In this 8-week intervention, components of Mindful Based Stress Reduction Program will be integrated with strengthening and neuromuscular exercises recommended for knee osteoarthritis. The goal of this program is to train participants how to be mindful during their exercises. |
|
|
| Primary | Attendance | Proportion of sessions attended | Posted | Mean | Standard Deviation | % sessions attended | post-intervention (at 8-weeks) |
|
|
|
| Primary | Retention Rate | Proportion of participants who complete patient-reported outcome surveys | Posted | Count of Participants | Participants | post-intervention visit (at the end of 8-weeks) |
|
|
|
| Primary | 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) | On the 19 participants randomized to TX group, 18 provided data for this outcome at week 8. Of the 21 participants assigned to the TMX group, 17 provided data for this outcome at week 8. Since the TX group did not receive any mindfulness training, outcome related to rating of the mindfulness intervention or instructor were not collected for this group. | Posted | Mean | Full Range | score on a scale | 8-week |
|
|
|
| Primary | Satisfaction Scale | Custom 4-item (0-10 scale) to determine satisfaction with individual components of the intervention (i.e.,, exercise, mindfulness, telehealth, and overall satisfaction). There are 4 items and each item is scored separately. Higher scores for each item mean greater satisfaction for that dimension. | On the 19 participants randomized to TX group, 18 provided data for this outcome at week 8. Of the 21 participants assigned to the TMX group, 17 provided data for this outcome at week 8. TX group did not receive the mindfulness intervention so the mindfulness item on this scale was not administered to this group | Posted | Mean | Full Range | score on a scale | 8-week |
|
|
|
| Secondary | 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. | On the 19 participants randomized to TX group, 18 provided data for this outcome at week 8 and week 14. Of the 21 participants assigned to the TMX group, 17 provided data for this outcome at week 8 and week 14. | Posted | Mean | 95% Confidence Interval | score on a scale | baseline, 8-week, 14-week |
|
|
|
| Secondary | Pain, Enjoyment, General Activity Scale | Assesses Pain Intensity and Interference. the response range is 0-10; the PEG scale score is the mean of the three individual item scores. Higher scores represent worse pain. | On the 19 participants randomized to TX group, 18 provided data for this outcome at week 8 and week 14. Of the 21 participants assigned to the TMX group, 17 provided data for this outcome at week 8 and week 14. | Posted | Mean | 95% Confidence Interval | score on a scale | baseline, 8-week, 14-week |
|
|
|
| Secondary | 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 | On the 19 participants randomized to TX group, 18 provided data for this outcome at week 8 and week 14. Of the 21 participants assigned to the TMX group, 17 provided data for this outcome at week 8 and week 14. | Posted | Mean | 95% Confidence Interval | score on a scale | baseline, 8-week, 14-week |
|
|
|
| Secondary | Participant Global Impression of Change | participant's rating of change in condition on a 14-point scale ranging from "a very great deal worse" to "a very great deal better". Values range from -7 to +7 (excluding 0). Score >=1 represent improvement and scores <= -1 represent worsening. | On the 19 participants randomized to TX group, 18 provided data for this outcome at week 8 and week 14. Of the 21 participants assigned to the TMX group, 16 provided data for this outcome at week 8 and 17 provided data for this outcome at week 14. | Posted | Mean | 95% Confidence Interval | score on a scale | 8-week, 14-week |
|
|
|
| Secondary | 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 | One participant in TX group and four participants in TMX Group were lost to follow-up | Posted | Mean | 95% Confidence Interval | score on a scale | baseline, 8-week, 14-week |
|
|
|
| Secondary | Pain Catastrophizing Scale | 3-item scale which measures of catastrophizing related to pain. Each item is rated on a 5-point scale: 0 (Not at all) to 4 (all the time). | On the 19 participants randomized to TX group, 18 provided data for this outcome at week 8. Of the 21 participants assigned to the TMX group, 17 provided data for this outcome at week 8. | Posted | Mean | 95% Confidence Interval | score on a scale | baseline, 8-week |
|
|
|
| Secondary | Widespread Pain Index Symptom Severity Scale | self-report 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. | On the 19 participants randomized to TX group, 18 provided data for this outcome at week 8. Of the 21 participants assigned to the TMX group, 17 provided data for this outcome at week 8. | Posted | Mean | 95% Confidence Interval | score on a scale | baseline, 8-week |
|
|
|
| Secondary | Pain DETECT | self-report measure on presence of neuropathic pain. each question is scored from 0 to 5 where higher scores indicate higher gradation of pain. The final score is between -1 and 38 and a score of 19 and higher indicates higher likelihood of neuropathic pain | On the 19 participants randomized to TX group, 18 provided data for this outcome at week 8. Of the 21 participants assigned to the TMX group, 20 provided data at baseline and 16 provided data for this outcome at week 8. | Posted | Mean | 95% Confidence Interval | score on a scale | baseline, 8-week |
|
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|
| Secondary | Patient Health Questionnaire 8-item | 8-item questionnaire assessing depression symptoms. Each question is scored from 0 to 3 where higher scores indicate higher frequency of experiencing depressive symptoms. Total score is the sum of individual item scores. Score range is 0-24. Higher total scores indicate greater severity of depression | On the 19 participants randomized to TX group, 18 provided data for this outcome at week 14. Of the 21 participants assigned to the TMX group, 17 provided data for this outcome at week 8 and week 14. | Posted | Mean | 95% Confidence Interval | score on a scale | baseline, 8-week, 14-week |
|
|
|
| Secondary | Cognitive and Affective Mindfulness Scale - Revised | 12-item scale on dispositional mindfulness. Items are rated on a 4-point Likert scale from 1 (rarely/not at all) to 4 (almost always). Scores on the scale are summed. Higher scores reflect greater mindfulness. | On the 19 participants randomized to TX group, 18 provided data for this outcome at week 8 and 17 provided data at week 14. Of the 21 participants assigned to the TMX group, 17 provided data for this outcome at week 8 and week 14. | Posted | Mean | 95% Confidence Interval | score on a scale | baseline, 8-week, 14-week |
|
|
|
| Secondary | Fear Avoidance Beliefs Questionnaire - Physical Activity | 4-item questionnaire to determine 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 summation of each item scores. Range is 0-24. Higher total scores indicate greater fear of physical activity | On the 19 participants randomized to TX group, 18 provided data for this outcome at week 8. Of the 21 participants assigned to the TMX group, 17 provided data for this outcome at week 8. | Posted | Mean | 95% Confidence Interval | score on a scale | baseline, 8-week |
|
|
|
| Secondary | Arthritis Self Efficacy Scale | Questionnaire to assess confidence in one's capacity to function despite pain. Each item in the questionnaire is scored on a 1-10 scale. It provides three subscales of pain, function, and other symptoms calculated as average of items contributing to that subscale. Range for each subscale is 1-10. Higher scores indicate greater self-efficacy to manage osteoarthritis. | Of the 21 participants assigned to the TMX group, 16 provided data for this outcome at week 8. | Posted | Mean | 95% Confidence Interval | score on a scale | baseline, 8-week |
|
|
|
| Secondary | Chronic Pain Self-efficacy Questionnaire | Measures three domains of pain self-efficacy: pain management, physical functioning, and coping with symptoms. Each item is scored on a scale of 0 (very uncertain) to 100 (very certain). Score for each domain is the average of all items contributing to that domain. Higher total scores indicate greater self-efficacy to manage one's chronic pain. | On the 19 participants randomized to TX group, 17 provided data for this outcome at week 8. Of the 21 participants assigned to the TMX group, 16 provided data for this outcome at week 8. | Posted | Mean | 95% Confidence Interval | score on a scale | baseline, 8-week |
|
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| Other Pre-specified | Arthritis - Rapid Estimate of Adult Literacy in Medicine (A-REALM) | 66-word recognition adult health literacy test. Each correct pronunciation of word is scored as 1. The total score is classified into 1 to 4 reading grade levels where higher scores (61-66) represent ninth grade and above reading level | Not Posted | baseline | Participants |
| Other Pre-specified | Sit to Stand Test [OPTIONAL IN-PERSON VISIT] | functional test that measures the time taken to sit and stand from chair five times | Not Posted | baseline, 8-week | Participants |
| Other Pre-specified | 6-minute Walk Test [OPTIONAL IN-PERSON VISIT] | functional test that measures the maximal distance covered while walking at fast-pace for six minutes | Not Posted | baseline, 8-week | Participants |
| Other Pre-specified | 7-meter Walk Test [OPTIONAL IN-PERSON VISIT] | functional test that measures comfortable walking speed as participant walks back and forth over 7 meters twice | Not Posted | baseline, 8-week | Participants |
| Other Pre-specified | Stair Climb Test [OPTIONAL IN-PERSON VISIT] | functional test that measures the time taken to ascend and descend a flight of stairs | Not Posted | baseline, 8-week | Participants |
| Other Pre-specified | Pressure Pain Threshold [OPTIONAL IN-PERSON VISIT] | a test of pain sensitivity | Not Posted | baseline, 8-week | Participants |
| Other Pre-specified | Mechanical Temporal Summation [OPTIONAL IN-PERSON VISIT] | a test of central pain sensitization | Not Posted | baseline, 8-week | Participants |
| Other Pre-specified | Conditioned Pain Modulation [OPTIONAL IN-PERSON VISIT] | a test of descending pain modulation | Not Posted | baseline, 8-week | Participants |
| Other Pre-specified | Exercise Induced Hypoalgesia [OPTIONAL IN-PERSON VISIT] | a test of change in pain sensitivity after a bout of exercise | Not Posted | baseline, 8-week | Participants |
| Other Pre-specified | Isometric Knee Extensor Force [OPTIONAL IN-PERSON VISIT] | knee extensor isometric muscle strength | Not Posted | baseline, 8-week | Participants |
| Other Pre-specified | Isometric Knee Flexor Force [OPTIONAL IN-PERSON VISIT] | knee flexor isometric muscle strength | Not Posted | baseline, 8-week | Participants |
| Other Pre-specified | Telehealth Usability Questionnaire | scale evaluating the usability and satisfaction of telehealth implementation and services. Each item is rated on a seven-point Likert scale, with a rating of one indicating disagree and a rating of seven indicating agree; higher ratings indicate better system usability | Not Posted | 8-week | Participants |
| Other Pre-specified | Weekly Log | log of minutes and days spent doing strengthening exercises, aerobic exercises, and mindfulness practice (mindfulness practice only applicable to people in the TMX group). Survey also includes log of oral analgesic use. | Not Posted | Weekly for 14-weeks | Participants |
| Other Pre-specified | Heal Treatment Expectancy Survey - Short Form | 6-item survey assessing participant's attitude and expectations of the intervention measured on a 5-point likert scale. higher scores indicate more positive attitude and expectations for the treatment | Not Posted | baseline | Participants |
| Other Pre-specified | Treatment History | a survey that collects information about the treatments the individual has undertaken for their knee osteoarthritis | Not Posted | baseline, week 8, week 14 | Participants |
| Other Pre-specified | eHealth Literacy Scale | 8-item scale measuring one's perceived ability and comfort with accessing digital services for health information. each item is rated on a 5-point likert scale. total scores are summed. higher scores indicate greater perceived skills at using online health information to help solve health problems | Not Posted | baseline | Participants |
| 0 |
| 19 |
| 0 |
| 19 |
| 8 |
| 19 |
| EG001 | Group TMX (Telehealth Exercise and Mindfulness) | Participants in this group will receive a supervised, group-based integrated mindfulness and exercise program once a week for 8 weeks via telehealth. Mindful Exercise program: In this 8-week intervention, components of Mindful Based Stress Reduction Program will be integrated with strengthening and neuromuscular exercises recommended for knee osteoarthritis. The goal of this program is to train participants how to be mindful during their exercises. | 0 | 21 | 0 | 21 | 3 | 21 |
|
| Hernia surgery | Surgical and medical procedures | Non-systematic Assessment | Adverse event unrelated to study |
|
| Flu | Infections and infestations | Non-systematic Assessment | Adverse event unrelated to study |
|
| Ankle injury | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Adverse event unrelated to study because event was reported before the start of the intervention sessions |
|
| Knee replacement surgery | Surgical and medical procedures | Non-systematic Assessment | Participant had scheduled a knee replacement surgery during the course of the study |
|
| Generally feeling unwell | General disorders | Non-systematic Assessment | Participant reported generally feeling unwell |
|
Not provided
Not provided
| D012216 |
| Rheumatic Diseases |
| D001519 | Behavior |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| The exercise instructor was a good role model |
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| The exercise instructor explained lessons clearly |
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| The exercise instructor was engaging |
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| The exercise instructor was helpful/answered all questions |
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| I enjoyed the exercise lessons |
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| I was engaged in the exercise lessons |
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| I was able to understand the exercise lessons |
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| I was able to integrate the information from the different exercise lessons |
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| I will be able to use the exercise lessons in my life |
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| The mindfulness instructor demonstrated good knowledge |
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| The mindfulness instructor was a good role model |
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| The mindfulness instructor explained lessons clearly |
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| The mindfulness instructor was engaging |
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| The mindfulness instructor was helpful/answered all questions |
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| I enjoyed the mindfulness lessons |
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| I was engaged in the mindfulness lessons |
|
|
| I was able to understand the mindfulness lessons |
|
|
| I was able to integrate the information from the different mindfulness lessons |
|
|
| I will be able to use the mindfulness lessons in my life |
|
|
| Mindfulness Component |
|
|
| Telehealth component |
|
|
| General participation |
|
|
| Pain Week-8 |
|
|
| Pain Week-14 |
|
|
| Symptoms Baseline |
|
|
| Symptoms Week-8 |
|
|
| Symptoms Week-14 |
|
|
| Activity of Daily Living Baseline |
|
|
| Activity of Daily Living Week-8 |
|
|
| Activity of Daily Living Week-14 |
|
|
| Sports and Recreation Baseline |
|
|
| Sports and Recreation Week-8 |
|
|
| Sports and Recreation Week-14 |
|
|
| Quality Of Life Baseline |
|
|
| Quality Of Life Week-8 |
|
|
| Quality Of Life Week-14 |
|
|
| Week-8 |
|
|
| Week-14 |
|
|
| Week-8 |
|
|
| Week-14 |
|
|
| Week-14 |
|
|
| Week-8 |
|
|
| Week-14 |
|
|
| Week-8 |
|
|
| Week-8 |
|
|
| Week-8 |
|
|
| Week-8 |
|
|
| Week-14 |
|
|
| Week-8 |
|
|
| Week-14 |
|
|
| Week-8 |
|
|
| Pain Week-8 |
|
|
| Function Baseline |
|
|
| Function Week-8 |
|
|
| Other symptoms Baseline |
|
|
| Other symptoms Week-8 |
|
|
| Pain Week-8 |
|
|
| Function Baseline |
|
|
| Function Week-8 |
|
|
| Coping Baseline |
|
|
| Coping Week-8 |
|
|