An interventional study of Mindful Exercise program and Exercise in Knee Osteoarthritis, sponsored by Boston University Charles River Campus. Completed at 1 site in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2025-01-16.
Sponsored by Boston University Charles River Campus · Not applicable, Interventional, and Treatment
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.
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's enrollment of 45 is below the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →Boston University Charles River Campus is the lead sponsor of 154 studies on the registry; 30 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 8 (57%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants in this group will receive a supervised and group-based exercise program once a week for 8 weeks via telehealth.
Behavioral: Exercise
Participants in this group will receive a supervised, group-based integrated mindfulness and exercise program once a week for 8 weeks via telehealth.
Behavioral: 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.
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.
Recruitment
Number of participants that are randomized for the study
Time frame: through the recruitment process, up to 6 months from the start of the study
Attendance
Proportion of sessions attended
Time frame: post-intervention (at 8-weeks)
Retention Rate
Proportion of participants who complete patient-reported outcome surveys
Time frame: 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)
Time frame: 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.
Time frame: 8-week
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, 8-week, 14-week
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.
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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).
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: baseline, 8-week
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
Time frame: baseline
Sit to Stand Test [OPTIONAL IN-PERSON VISIT]
functional test that measures the time taken to sit and stand from chair five times
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: baseline, 8-week
Pressure Pain Threshold [OPTIONAL IN-PERSON VISIT]
a test of pain sensitivity
Time frame: baseline, 8-week
Mechanical Temporal Summation [OPTIONAL IN-PERSON VISIT]
a test of central pain sensitization
Time frame: baseline, 8-week
Conditioned Pain Modulation [OPTIONAL IN-PERSON VISIT]
a test of descending pain modulation
Time frame: baseline, 8-week
Exercise Induced Hypoalgesia [OPTIONAL IN-PERSON VISIT]
a test of change in pain sensitivity after a bout of exercise
Time frame: baseline, 8-week
Isometric Knee Extensor Force [OPTIONAL IN-PERSON VISIT]
knee extensor isometric muscle strength
Time frame: baseline, 8-week
Isometric Knee Flexor Force [OPTIONAL IN-PERSON VISIT]
knee flexor isometric muscle strength
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: baseline
Treatment History
a survey that collects information about the treatments the individual has undertaken for their knee osteoarthritis
Time frame: 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
Time frame: baseline
| Milestone | Group TX (Telehealth Exercise) | Group TMX (Telehealth Exercise and Mindfulness) |
|---|---|---|
| Started | 19 | 21 |
| Completed | 19 | 18 |
| Not completed | 0 | 3 |
| Withdrew: Brain tumor flare up | 0 | 1 |
| Withdrew: Concussion | 0 | 1 |
| Withdrew: Hernia surgery | 0 | 1 |
| Milestone | Group TX (Telehealth Exercise) | Group TMX (Telehealth Exercise and Mindfulness) |
|---|---|---|
| Started | 19 | 18 |
| Completed | 18 | 17 |
| Not completed | 1 | 1 |
| Withdrew: Caregiver for sick family member | 1 | 0 |
| Withdrew: Lost to follow-up | 0 | 1 |
Number of participants that are randomized for the study
| Participants | Group TX (Telehealth Exercise) | Group TMX (Telehealth Exercise and Mindfulness) |
|---|---|---|
| Recruitment | 19 | 21 |
Proportion of sessions attended
| % sessions attended | Group TX (Telehealth Exercise) | Group TMX (Telehealth Exercise and Mindfulness) |
|---|---|---|
| Attendance | 68 ± 34 | 54 ± 39 |
Proportion of participants who complete patient-reported outcome surveys
| Participants | Group TX (Telehealth Exercise) | Group TMX (Telehealth Exercise and Mindfulness) |
|---|---|---|
| Retention Rate | 19 | 18 |
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)
| score on a scale | Group TX (Telehealth Exercise) | Group TMX (Telehealth Exercise and Mindfulness) |
|---|---|---|
| The exercise instructor demonstrated good knowledge | 3.56 (2 to 4) | 3.29 (2 to 4) |
| The exercise instructor was a good role model | 3.44 (2 to 4) | 3.35 (2 to 4) |
| The exercise instructor explained lessons clearly | 3.33 (1 to 4) | 3.38 (2 to 4) |
| The exercise instructor was engaging | 3.39 (2 to 4) | 3.44 (2 to 4) |
| The exercise instructor was helpful/answered all questions | 3.33 (1 to 4) | 3.44 (2 to 4) |
| I enjoyed the exercise lessons | 3.11 (1 to 4) | 2.88 (1 to 4) |
| I was engaged in the exercise lessons | 3.39 (1 to 4) | 3.12 (2 to 4) |
| I was able to understand the exercise lessons | 3.56 (2 to 4) | 3.24 (2 to 4) |
| I was able to integrate the information from the different exercise lessons | 3.39 (2 to 4) | 3.19 (2 to 4) |
| I will be able to use the exercise lessons in my life | 3.22 (0 to 4) | 3.25 (2 to 4) |
| The mindfulness instructor demonstrated good knowledge | — | 3.35 (2 to 4) |
| The mindfulness instructor was a good role model | — | 3.35 (2 to 4) |
| The mindfulness instructor explained lessons clearly | — | 3.24 (2 to 4) |
| The mindfulness instructor was engaging | — | 3.29 (2 to 4) |
| The mindfulness instructor was helpful/answered all questions | — | 3.29 (2 to 4) |
| I enjoyed the mindfulness lessons | — | 2.71 (1 to 4) |
| I was engaged in the mindfulness lessons | — | 3.12 (2 to 4) |
| I was able to understand the mindfulness lessons | — | 3.12 (1 to 4) |
| I was able to integrate the information from the different mindfulness lessons | — | 3.24 (2 to 4) |
| I will be able to use the mindfulness lessons in my life | — | 3 (2 to 4) |
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.
| score on a scale | Group TX (Telehealth Exercise) | Group TMX (Telehealth Exercise and Mindfulness) |
|---|---|---|
| Exercise component | 8.1 (2.0 to 10.0) | 8.2 (5.0 to 10.0) |
| Mindfulness Component | — | 7.3 (2.0 to 10.0) |
| Telehealth component | 8.1 (1.0 to 10.0) | 7.9 (5.0 to 10.0) |
| General participation | 7.9 (1.0 to 10.0) | 8.1 (5.0 to 10.0) |
Patient-reported outcome for knee pain and disability; a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems.
| score on a scale | Group TX (Telehealth Exercise) | Group TMX (Telehealth Exercise and Mindfulness) |
|---|---|---|
| Pain Baseline | 61.3 (57.6 to 64.9) | 57.7 (52.6 to 62.7) |
| Pain Week-8 | 63.7 (57.9 to 69.5) | 61.8 (54.4 to 69.1) |
| Pain Week-14 | 63.8 (57.3 to 70.3) | 64.2 (57 to 71.4) |
| Symptoms Baseline | 59.7 (54.3 to 65) | 59.4 (53.9 to 65) |
| Symptoms Week-8 | 63.1 (58.5 to 67.8) | 59.9 (53.7 to 66.1) |
| Symptoms Week-14 | 68.8 (63 to 74.5) | 62.1 (54 to 70.3) |
| Activity of Daily Living Baseline | 72.1 (66.7 to 77.6) | 63 (57.8 to 68.1) |
| Activity of Daily Living Week-8 | 72.6 (66.4 to 78.8) | 68.2 (60.3 to 76.1) |
| Activity of Daily Living Week-14 | 71.4 (64.2 to 78.7) | 68.5 (62.4 to 74.6) |
| Sports and Recreation Baseline | 48.1 (37.5 to 58.6) | 37.4 (31.1 to 43.7) |
| Sports and Recreation Week-8 | 47.2 (34.2 to 60.3) | 40.6 (32.4 to 48.7) |
| Sports and Recreation Week-14 | 42.8 (30.6 to 55.1) | 45.3 (36.5 to 54.1) |
| Quality Of Life Baseline | 45.8 (41.6 to 50) | 41.1 (35.1 to 47.1) |
| Quality Of Life Week-8 | 49 (44.1 to 53.8) | 48.5 (42.4 to 54.6) |
| Quality Of Life Week-14 | 52.1 (46.4 to 57.8) | 52.6 (44.4 to 60.7) |
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.
| score on a scale | Group TX (Telehealth Exercise) | Group TMX (Telehealth Exercise and Mindfulness) |
|---|---|---|
| Baseline | 4.9 (4.2 to 5.6) | 5.4 (4.6 to 6.1) |
| Week-8 | 4 (2.9 to 5) | 3.9 (3 to 4.7) |
| Week-14 | 3.9 (2.9 to 4.9) | 3.4 (2.5 to 4.4) |
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
| score on a scale | Group TX (Telehealth Exercise) | Group TMX (Telehealth Exercise and Mindfulness) |
|---|---|---|
| Baseline | 6.1 (5.3 to 6.9) | 6.5 (6.1 to 6.9) |
| Week-8 | 5.1 (4 to 6.2) | 5.2 (4.4 to 5.9) |
| Week-14 | 4.8 (3.8 to 5.9) | 4.8 (3.8 to 5.7) |
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.
| score on a scale | Group TX (Telehealth Exercise) | Group TMX (Telehealth Exercise and Mindfulness) |
|---|---|---|
| Week-8 | 2.2 (1 to 3.4) | 2.4 (1.2 to 3.7) |
| Week-14 | 1.4 (0.1 to 2.7) | 2.2 (1.1 to 3.3) |
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
| score on a scale | Group TX (Telehealth Exercise) | Group TMX (Telehealth Exercise and Mindfulness) |
|---|---|---|
| Baseline | 59.8 (49.2 to 70.4) | 63.7 (54.7 to 72.6) |
| Week-8 | 64.5 (54.5 to 74.5) | 65.7 (56.9 to 74.5) |
| Week-14 | 60.2 (50.8 to 69.5) | 68.7 (60.7 to 76.7) |
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).
| score on a scale | Group TX (Telehealth Exercise) | Group TMX (Telehealth Exercise and Mindfulness) |
|---|---|---|
| Baseline | 3.5 (2.7 to 4.4) | 3.9 (2.9 to 4.9) |
| Week-8 | 3.4 (2.3 to 4.6) | 3.1 (2 to 4.1) |
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.
| score on a scale | Group TX (Telehealth Exercise) | Group TMX (Telehealth Exercise and Mindfulness) |
|---|---|---|
| Baseline | 3.9 (3 to 4.8) | 3.1 (2.2 to 4.1) |
| Week-8 | 4.1 (2.9 to 5.3) | 3.7 (2.6 to 4.9) |
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
| score on a scale | Group TX (Telehealth Exercise) | Group TMX (Telehealth Exercise and Mindfulness) |
|---|---|---|
| Baseline | 9.8 (7.1 to 12.4) | 8.5 (6.6 to 10.4) |
| Week-8 | 9.4 (7 to 11.8) | 7.6 (4.9 to 10.4) |
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
| score on a scale | Group TX (Telehealth Exercise) | Group TMX (Telehealth Exercise and Mindfulness) |
|---|---|---|
| Baseline | 4.6 (2.3 to 6.9) | 3 (1.7 to 4.3) |
| Week-8 | 3.7 (2.2 to 5.3) | 3.9 (1.9 to 6) |
| Week-14 | 3.9 (2.4 to 5.5) | 4.1 (1.9 to 6.3) |
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.
| score on a scale | Group TX (Telehealth Exercise) | Group TMX (Telehealth Exercise and Mindfulness) |
|---|---|---|
| Baseline | 35.3 (32.7 to 37.8) | 37.4 (34.5 to 40.3) |
| Week-8 | 33.9 (30.6 to 37.3) | 36.4 (33 to 39.9) |
| Week-14 | 35.2 (32.1 to 38.4) | 37.3 (33.4 to 41.2) |
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
| score on a scale | Group TX (Telehealth Exercise) | Group TMX (Telehealth Exercise and Mindfulness) |
|---|---|---|
| Baseline | 18.3 (16.1 to 20.5) | 15.5 (12.9 to 18.1) |
| Week-8 | 16.7 (13.4 to 20) | 14.8 (11.6 to 18.1) |
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.
| score on a scale | Group TX (Telehealth Exercise) | Group TMX (Telehealth Exercise and Mindfulness) |
|---|---|---|
| Pain Baseline | 6.5 (5.8 to 7.3) | 6.1 (5.6 to 6.6) |
| Pain Week-8 | 7.1 (6.3 to 7.9) | 6.2 (5.3 to 7.1) |
| Function Baseline | 8 (7.4 to 8.7) | 7.7 (7.1 to 8.2) |
| Function Week-8 | 8.1 (7.2 to 9.1) | 8 (7.2 to 8.8) |
| Other symptoms Baseline | 7 (6.2 to 7.7) | 6.8 (6.2 to 7.3) |
| Other symptoms Week-8 | 7.1 (6.3 to 7.9) | 7.2 (6.4 to 8.1) |
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.
| score on a scale | Group TX (Telehealth Exercise) | Group TMX (Telehealth Exercise and Mindfulness) |
|---|---|---|
| Pain Baseline | 71.5 (64.6 to 78.4) | 66.2 (59.6 to 72.7) |
| Pain Week-8 | 66.8 (56.8 to 76.8) | 66.9 (59.1 to 74.8) |
| Function Baseline | 86 (78.8 to 93.2) | 81.4 (74.7 to 88.1) |
| Function Week-8 | 82.2 (72.3 to 92.2) | 78.2 (66.5 to 89.9) |
| Coping Baseline | 68.1 (60.1 to 76) | 72.6 (66.3 to 78.8) |
| Coping Week-8 | 71.2 (62.1 to 80.3) | 70.5 (60.6 to 80.5) |
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
Results for this outcome have not been posted.
functional test that measures the time taken to sit and stand from chair five times
Results for this outcome have not been posted.
functional test that measures the maximal distance covered while walking at fast-pace for six minutes
Results for this outcome have not been posted.
functional test that measures comfortable walking speed as participant walks back and forth over 7 meters twice
Results for this outcome have not been posted.
functional test that measures the time taken to ascend and descend a flight of stairs
Results for this outcome have not been posted.
a test of pain sensitivity
Results for this outcome have not been posted.
a test of central pain sensitization
Results for this outcome have not been posted.
a test of descending pain modulation
Results for this outcome have not been posted.
a test of change in pain sensitivity after a bout of exercise
Results for this outcome have not been posted.
knee extensor isometric muscle strength
Results for this outcome have not been posted.
knee flexor isometric muscle strength
Results for this outcome have not been posted.
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
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
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
Results for this outcome have not been posted.
a survey that collects information about the treatments the individual has undertaken for their knee osteoarthritis
Results for this outcome have not been posted.
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
Results for this outcome have not been posted.
Collected over 14-weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group TX (Telehealth Exercise) | 0/19 (0%) | 0/19 (0%) | 8/19 (42.1%) |
| Group TMX (Telehealth Exercise and Mindfulness) | 0/21 (0%) | 0/21 (0%) | 3/21 (14.3%) |
| Event | Group TX (Telehealth Exercise) | Group TMX (Telehealth Exercise and Mindfulness) |
|---|---|---|
| Exacerbation of knee painMusculoskeletal and connective tissue disorders | 4/19 | 0/21 |
| FluInfections and infestations | 2/19 | 1/21 |
| Knee replacement surgerySurgical and medical procedures | 1/19 | 0/21 |
| Generally feeling unwellGeneral disorders | 1/19 | 0/21 |
| Hernia surgerySurgical and medical procedures | 0/19 | 1/21 |
| Ankle injuryMusculoskeletal and connective tissue disorders | 0/19 | 1/21 |
| Age, Continuous(years) | Group TX (Telehealth Exercise) | Group TMX (Telehealth Exercise and Mindfulness) | Total |
|---|---|---|---|
| Mean | 67.4 ± 7.4 | 63.8 ± 8.9 | 65.5 ± 8.3 |
| Sex: Female, Male(Participants) | Group TX (Telehealth Exercise) | Group TMX (Telehealth Exercise and Mindfulness) | Total |
|---|---|---|---|
| Female | 17 | 18 | 35 |
| Male | 2 | 3 | 5 |
| Race (NIH/OMB)(Participants) | Group TX (Telehealth Exercise) | Group TMX (Telehealth Exercise and Mindfulness) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 0 | 1 |
| White | 18 | 19 | 37 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 1 | 1 |
| Education(Participants) | Group TX (Telehealth Exercise) | Group TMX (Telehealth Exercise and Mindfulness) | Total |
|---|---|---|---|
| High school or College 1 - 3 years | 6 | 8 | 14 |
| Undergraduate, graduate, or doctorate | 13 | 13 | 26 |
| Annual income(Participants) | Group TX (Telehealth Exercise) | Group TMX (Telehealth Exercise and Mindfulness) | Total |
|---|---|---|---|
| More than 50,000$ | 10 | 11 | 21 |
| Less than 50,000$ | 8 | 9 | 17 |
| Did not report | 1 | 1 | 2 |
| Marital Status(Participants) | Group TX (Telehealth Exercise) | Group TMX (Telehealth Exercise and Mindfulness) | Total |
|---|---|---|---|
| Married | 9 | 10 | 19 |
| Widowed, divorced, single, or not reported | 10 | 11 | 21 |
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Boston University Charles River Campus