Knee Osteoarthritis
Conditions
Keywords
telehealth, exercise, mindfulness, pain, feasibility
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALMindful 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.
BEHAVIORALExercise
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.
Sponsors
Boston University Charles River Campus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention model description
Parallel-arm randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Meet National Institute for Health and Clinical Excellence clinical guidelines for knee osteoarthritis (i.e., age ≥ 50 years, presence of activity related pain, presence of morning knee stiffness ≤ 30 minutes) * BMI\<40 * Knee pain on most days for 3 months or more * Average overall knee pain severity of ≥= 4 on a 11-point numeric rating scale during previous week * Able to attend remote sessions * Can speak and understand English at a sufficient level to understand the study procedures and informed consent. * Available for study duration
Exclusion criteria
* Contraindications to exercise * Other pain in lower back or legs that is greater than knee pain * Received physical therapy treatment for knee OA in the past 6 months or currently receiving physical therapy * Received any mindfulness programs such as Tai Chi, meditation, etc. in the past 6 months or currently receiving such program * Currently receiving chemotherapy or radiation therapy for cancer except non-melanoma skin cancer * History of other disease that may involve the index joint including inflammatory joint disease such as rheumatoid arthritis, seronegative spondyloarthropathy (eg, ankylosing spondylitis, psoriatic arthritis, inflammatory bowel disease related arthropathy), crystalline disease (eg, gout or pseudogout), lupus erythematosus, knee joint infections, Paget's disease affecting the knee, or knee joint tumors. * Any knee surgery in the previous 6 months * Joint replacement in either hip or ankle * Previous knee osteotomy partial or total knee replacement in either knee * Planned major treatment for knee OA (e.g., surgery, injections, physical therapy) during the study period * Planned major surgery in the next 6 months * Corticosteroid or hyaluronic acid injections in either knee in the previous 3 months * Neurological conditions that impacts motor functioning (e.g., stroke, Parkinson's disease, Alzheimer's disease, Multiple Sclerosis, diabetic neuropathy, etc). * Pregnancy (self-report) * Participation in another clinical trial for any joint or muscle pain * Suspected or known drugs or alcohol abuse
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment | through the recruitment process, up to 6 months from the start of the study | Number of participants that are randomized for the study |
| Satisfaction Scale | 8-week | 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. |
| Participant Feedback Survey | 8-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) |
| Retention Rate | post-intervention visit (at the end of 8-weeks) | Proportion of participants who complete patient-reported outcome surveys |
| Attendance | post-intervention (at 8-weeks) | Proportion of sessions attended |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain, Enjoyment, General Activity Scale | baseline, 8-week, 14-week | 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. |
| Knee Injury and Osteoarthritis Outcome Score | baseline, 8-week, 14-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. |
| Numeric Rating Scale - Nominated Activity | baseline, 8-week, 14-week | 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 |
| Participant Global Impression of Change | 8-week, 14-week | 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. |
| Patient Global Assessment of Osteoarthritis | baseline, 8-week, 14-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 |
| Pain Catastrophizing Scale | baseline, 8-week | 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). |
| Widespread Pain Index Symptom Severity Scale | baseline, 8-week | 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. |
| Pain DETECT | baseline, 8-week | 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 |
| Patient Health Questionnaire 8-item | baseline, 8-week, 14-week | 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 |
| Cognitive and Affective Mindfulness Scale - Revised | baseline, 8-week, 14-week | 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. |
| Fear Avoidance Beliefs Questionnaire - Physical Activity | baseline, 8-week | 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 |
| Arthritis Self Efficacy Scale | baseline, 8-week | 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. |
| Chronic Pain Self-efficacy Questionnaire | baseline, 8-week | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Sit to Stand Test [OPTIONAL IN-PERSON VISIT] | baseline, 8-week | functional test that measures the time taken to sit and stand from chair five times |
| Pressure Pain Threshold [OPTIONAL IN-PERSON VISIT] | baseline, 8-week | a test of pain sensitivity |
| Stair Climb Test [OPTIONAL IN-PERSON VISIT] | baseline, 8-week | functional test that measures the time taken to ascend and descend a flight of stairs |
| 7-meter Walk Test [OPTIONAL IN-PERSON VISIT] | baseline, 8-week | functional test that measures comfortable walking speed as participant walks back and forth over 7 meters twice |
| Mechanical Temporal Summation [OPTIONAL IN-PERSON VISIT] | baseline, 8-week | a test of central pain sensitization |
| Conditioned Pain Modulation [OPTIONAL IN-PERSON VISIT] | baseline, 8-week | a test of descending pain modulation |
| Exercise Induced Hypoalgesia [OPTIONAL IN-PERSON VISIT] | baseline, 8-week | a test of change in pain sensitivity after a bout of exercise |
| Isometric Knee Extensor Force [OPTIONAL IN-PERSON VISIT] | baseline, 8-week | knee extensor isometric muscle strength |
| Isometric Knee Flexor Force [OPTIONAL IN-PERSON VISIT] | baseline, 8-week | knee flexor isometric muscle strength |
| Telehealth Usability Questionnaire | 8-week | 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 |
| Weekly Log | Weekly for 14-weeks | 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. |
| Heal Treatment Expectancy Survey - Short Form | baseline | 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 |
| Treatment History | baseline, week 8, week 14 | a survey that collects information about the treatments the individual has undertaken for their knee osteoarthritis |
| eHealth Literacy Scale | baseline | 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 |
| 6-minute Walk Test [OPTIONAL IN-PERSON VISIT] | baseline, 8-week | functional test that measures the maximal distance covered while walking at fast-pace for six minutes |
| Arthritis - Rapid Estimate of Adult Literacy in Medicine (A-REALM) | baseline | 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 |
Countries
United States
Participant flow
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| 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. | 19 |
| 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. | 21 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Baseline to Postintervention (Week 8) | Brain tumor flare up | 0 | 1 |
| Baseline to Postintervention (Week 8) | concussion | 0 | 1 |
| Baseline to Postintervention (Week 8) | hernia surgery | 0 | 1 |
| Week 8 to Follow-up (Week 14) | Caregiver for sick family member | 1 | 0 |
| Week 8 to Follow-up (Week 14) | Lost to Follow-up | 0 | 1 |
Baseline characteristics
| Characteristic | Group TX (Telehealth Exercise) | Group TMX (Telehealth Exercise and Mindfulness) | Total |
|---|---|---|---|
| Age, Continuous | 67.4 years STANDARD_DEVIATION 7.4 | 63.8 years STANDARD_DEVIATION 8.9 | 65.5 years STANDARD_DEVIATION 8.3 |
| Annual income Did not report | 1 Participants | 1 Participants | 2 Participants |
| Annual income Less than 50,000$ | 8 Participants | 9 Participants | 17 Participants |
| Annual income More than 50,000$ | 10 Participants | 11 Participants | 21 Participants |
| Education High school or College 1 - 3 years | 6 Participants | 8 Participants | 14 Participants |
| Education Undergraduate, graduate, or doctorate | 13 Participants | 13 Participants | 26 Participants |
| Marital Status Married | 9 Participants | 10 Participants | 19 Participants |
| Marital Status Widowed, divorced, single, or not reported | 10 Participants | 11 Participants | 21 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 18 Participants | 19 Participants | 37 Participants |
| Sex: Female, Male Female | 17 Participants | 18 Participants | 35 Participants |
| Sex: Female, Male Male | 2 Participants | 3 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 21 |
| other Total, other adverse events | 8 / 19 | 3 / 21 |
| serious Total, serious adverse events | 0 / 19 | 0 / 21 |
Outcome results
Primary
Attendance
Proportion of sessions attended
Time frame: post-intervention (at 8-weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group TX (Telehealth Exercise) | Attendance | 68 % sessions attended | Standard Deviation 34 |
| Group TMX (Telehealth Exercise and Mindfulness) | Attendance | 54 % sessions attended | Standard Deviation 39 |
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)
Time frame: 8-week
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Group TX (Telehealth Exercise) | Participant Feedback Survey | The exercise instructor was engaging | 3.39 score on a scale |
| Group TX (Telehealth Exercise) | Participant Feedback Survey | I was engaged in the exercise lessons | 3.39 score on a scale |
| Group TX (Telehealth Exercise) | Participant Feedback Survey | The exercise instructor explained lessons clearly | 3.33 score on a scale |
| Group TX (Telehealth Exercise) | Participant Feedback Survey | I was able to understand the exercise lessons | 3.56 score on a scale |
| Group TX (Telehealth Exercise) | Participant Feedback Survey | The exercise instructor was helpful/answered all questions | 3.33 score on a scale |
| Group TX (Telehealth Exercise) | Participant Feedback Survey | I was able to integrate the information from the different exercise lessons | 3.39 score on a scale |
| Group TX (Telehealth Exercise) | Participant Feedback Survey | The exercise instructor was a good role model | 3.44 score on a scale |
| Group TX (Telehealth Exercise) | Participant Feedback Survey | I will be able to use the exercise lessons in my life | 3.22 score on a scale |
| Group TX (Telehealth Exercise) | Participant Feedback Survey | I enjoyed the exercise lessons | 3.11 score on a scale |
| Group TX (Telehealth Exercise) | Participant Feedback Survey | The exercise instructor demonstrated good knowledge | 3.56 score on a scale |
| Group TMX (Telehealth Exercise and Mindfulness) | Participant Feedback Survey | I will be able to use the exercise lessons in my life | 3.25 score on a scale |
| Group TMX (Telehealth Exercise and Mindfulness) | Participant Feedback Survey | The mindfulness instructor demonstrated good knowledge | 3.35 score on a scale |
| Group TMX (Telehealth Exercise and Mindfulness) | Participant Feedback Survey | The mindfulness instructor was a good role model | 3.35 score on a scale |
| Group TMX (Telehealth Exercise and Mindfulness) | Participant Feedback Survey | The mindfulness instructor explained lessons clearly | 3.24 score on a scale |
| Group TMX (Telehealth Exercise and Mindfulness) | Participant Feedback Survey | The mindfulness instructor was engaging | 3.29 score on a scale |
| Group TMX (Telehealth Exercise and Mindfulness) | Participant Feedback Survey | The mindfulness instructor was helpful/answered all questions | 3.29 score on a scale |
| Group TMX (Telehealth Exercise and Mindfulness) | Participant Feedback Survey | I enjoyed the mindfulness lessons | 2.71 score on a scale |
| Group TMX (Telehealth Exercise and Mindfulness) | Participant Feedback Survey | I was engaged in the mindfulness lessons | 3.12 score on a scale |
| Group TMX (Telehealth Exercise and Mindfulness) | Participant Feedback Survey | I was able to understand the mindfulness lessons | 3.12 score on a scale |
| Group TMX (Telehealth Exercise and Mindfulness) | Participant Feedback Survey | I was able to integrate the information from the different mindfulness lessons | 3.24 score on a scale |
| Group TMX (Telehealth Exercise and Mindfulness) | Participant Feedback Survey | I will be able to use the mindfulness lessons in my life | 3 score on a scale |
| Group TMX (Telehealth Exercise and Mindfulness) | Participant Feedback Survey | The exercise instructor demonstrated good knowledge | 3.29 score on a scale |
| Group TMX (Telehealth Exercise and Mindfulness) | Participant Feedback Survey | The exercise instructor was a good role model | 3.35 score on a scale |
| Group TMX (Telehealth Exercise and Mindfulness) | Participant Feedback Survey | The exercise instructor explained lessons clearly | 3.38 score on a scale |
| Group TMX (Telehealth Exercise and Mindfulness) | Participant Feedback Survey | The exercise instructor was engaging | 3.44 score on a scale |
| Group TMX (Telehealth Exercise and Mindfulness) | Participant Feedback Survey | The exercise instructor was helpful/answered all questions | 3.44 score on a scale |
| Group TMX (Telehealth Exercise and Mindfulness) | Participant Feedback Survey | I enjoyed the exercise lessons | 2.88 score on a scale |
| Group TMX (Telehealth Exercise and Mindfulness) | Participant Feedback Survey | I was engaged in the exercise lessons | 3.12 score on a scale |
| Group TMX (Telehealth Exercise and Mindfulness) | Participant Feedback Survey | I was able to understand the exercise lessons | 3.24 score on a scale |
| Group TMX (Telehealth Exercise and Mindfulness) | Participant Feedback Survey | I was able to integrate the information from the different exercise lessons | 3.19 score on a scale |
Primary
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
Population: A total of 40 randomized over 6 months (Oct 2022 - March 2023)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group TX (Telehealth Exercise) | Recruitment | 19 Participants |
| Group TMX (Telehealth Exercise and Mindfulness) | Recruitment | 21 Participants |
Primary
Retention Rate
Proportion of participants who complete patient-reported outcome surveys
Time frame: post-intervention visit (at the end of 8-weeks)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group TX (Telehealth Exercise) | Retention Rate | 19 Participants |
| Group TMX (Telehealth Exercise and Mindfulness) | Retention Rate | 18 Participants |
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.
Time frame: 8-week
Population: 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
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Group TX (Telehealth Exercise) | Satisfaction Scale | Telehealth component | 8.1 score on a scale |
| Group TX (Telehealth Exercise) | Satisfaction Scale | Exercise component | 8.1 score on a scale |
| Group TX (Telehealth Exercise) | Satisfaction Scale | General participation | 7.9 score on a scale |
| Group TMX (Telehealth Exercise and Mindfulness) | Satisfaction Scale | General participation | 8.1 score on a scale |
| Group TMX (Telehealth Exercise and Mindfulness) | Satisfaction Scale | Telehealth component | 7.9 score on a scale |
| Group TMX (Telehealth Exercise and Mindfulness) | Satisfaction Scale | Exercise component | 8.2 score on a scale |
| Group TMX (Telehealth Exercise and Mindfulness) | Satisfaction Scale | Mindfulness Component | 7.3 score on a scale |
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.
Time frame: baseline, 8-week
Population: Of the 21 participants assigned to the TMX group, 16 provided data for this outcome at week 8.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Group TX (Telehealth Exercise) | Arthritis Self Efficacy Scale | Pain Baseline | 6.5 score on a scale |
| Group TX (Telehealth Exercise) | Arthritis Self Efficacy Scale | Pain Week-8 | 7.1 score on a scale |
| Group TX (Telehealth Exercise) | Arthritis Self Efficacy Scale | Function Baseline | 8 score on a scale |
| Group TX (Telehealth Exercise) | Arthritis Self Efficacy Scale | Function Week-8 | 8.1 score on a scale |
| Group TX (Telehealth Exercise) | Arthritis Self Efficacy Scale | Other symptoms Baseline | 7 score on a scale |
| Group TX (Telehealth Exercise) | Arthritis Self Efficacy Scale | Other symptoms Week-8 | 7.1 score on a scale |
| Group TMX (Telehealth Exercise and Mindfulness) | Arthritis Self Efficacy Scale | Other symptoms Baseline | 6.8 score on a scale |
| Group TMX (Telehealth Exercise and Mindfulness) | Arthritis Self Efficacy Scale | Pain Baseline | 6.1 score on a scale |
| Group TMX (Telehealth Exercise and Mindfulness) | Arthritis Self Efficacy Scale | Function Week-8 | 8 score on a scale |
| Group TMX (Telehealth Exercise and Mindfulness) | Arthritis Self Efficacy Scale | Pain Week-8 | 6.2 score on a scale |
| Group TMX (Telehealth Exercise and Mindfulness) | Arthritis Self Efficacy Scale | Other symptoms Week-8 | 7.2 score on a scale |
| Group TMX (Telehealth Exercise and Mindfulness) | Arthritis Self Efficacy Scale | Function Baseline | 7.7 score on a scale |
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.
Time frame: baseline, 8-week
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Group TX (Telehealth Exercise) | Chronic Pain Self-efficacy Questionnaire | Coping Week-8 | 71.2 score on a scale |
| Group TX (Telehealth Exercise) | Chronic Pain Self-efficacy Questionnaire | Pain Week-8 | 66.8 score on a scale |
| Group TX (Telehealth Exercise) | Chronic Pain Self-efficacy Questionnaire | Function Baseline | 86 score on a scale |
| Group TX (Telehealth Exercise) | Chronic Pain Self-efficacy Questionnaire | Function Week-8 | 82.2 score on a scale |
| Group TX (Telehealth Exercise) | Chronic Pain Self-efficacy Questionnaire | Coping Baseline | 68.1 score on a scale |
| Group TX (Telehealth Exercise) | Chronic Pain Self-efficacy Questionnaire | Pain Baseline | 71.5 score on a scale |
| Group TMX (Telehealth Exercise and Mindfulness) | Chronic Pain Self-efficacy Questionnaire | Coping Baseline | 72.6 score on a scale |
| Group TMX (Telehealth Exercise and Mindfulness) | Chronic Pain Self-efficacy Questionnaire | Pain Baseline | 66.2 score on a scale |
| Group TMX (Telehealth Exercise and Mindfulness) | Chronic Pain Self-efficacy Questionnaire | Function Week-8 | 78.2 score on a scale |
| Group TMX (Telehealth Exercise and Mindfulness) | Chronic Pain Self-efficacy Questionnaire | Pain Week-8 | 66.9 score on a scale |
| Group TMX (Telehealth Exercise and Mindfulness) | Chronic Pain Self-efficacy Questionnaire | Coping Week-8 | 70.5 score on a scale |
| Group TMX (Telehealth Exercise and Mindfulness) | Chronic Pain Self-efficacy Questionnaire | Function Baseline | 81.4 score on a scale |
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.
Time frame: baseline, 8-week, 14-week
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Group TX (Telehealth Exercise) | Cognitive and Affective Mindfulness Scale - Revised | Baseline | 35.3 score on a scale |
| Group TX (Telehealth Exercise) | Cognitive and Affective Mindfulness Scale - Revised | Week-8 | 33.9 score on a scale |
| Group TX (Telehealth Exercise) | Cognitive and Affective Mindfulness Scale - Revised | Week-14 | 35.2 score on a scale |
| Group TMX (Telehealth Exercise and Mindfulness) | Cognitive and Affective Mindfulness Scale - Revised | Baseline | 37.4 score on a scale |
| Group TMX (Telehealth Exercise and Mindfulness) | Cognitive and Affective Mindfulness Scale - Revised | Week-8 | 36.4 score on a scale |
| Group TMX (Telehealth Exercise and Mindfulness) | Cognitive and Affective Mindfulness Scale - Revised | Week-14 | 37.3 score on a scale |
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
Time frame: baseline, 8-week
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Group TX (Telehealth Exercise) | Fear Avoidance Beliefs Questionnaire - Physical Activity | Week-8 | 16.7 score on a scale |
| Group TX (Telehealth Exercise) | Fear Avoidance Beliefs Questionnaire - Physical Activity | Baseline | 18.3 score on a scale |
| Group TMX (Telehealth Exercise and Mindfulness) | Fear Avoidance Beliefs Questionnaire - Physical Activity | Baseline | 15.5 score on a scale |
| Group TMX (Telehealth Exercise and Mindfulness) | Fear Avoidance Beliefs Questionnaire - Physical Activity | Week-8 | 14.8 score on a scale |
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.
Time frame: baseline, 8-week, 14-week
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Group TX (Telehealth Exercise) | Knee Injury and Osteoarthritis Outcome Score | Symptoms Week-8 | 63.1 score on a scale |
| Group TX (Telehealth Exercise) | Knee Injury and Osteoarthritis Outcome Score | Activity of Daily Living Week-14 | 71.4 score on a scale |
| Group TX (Telehealth Exercise) | Knee Injury and Osteoarthritis Outcome Score | Pain Week-8 | 63.7 score on a scale |
| Group TX (Telehealth Exercise) | Knee Injury and Osteoarthritis Outcome Score | Sports and Recreation Baseline | 48.1 score on a scale |
| Group TX (Telehealth Exercise) | Knee Injury and Osteoarthritis Outcome Score | Symptoms Week-14 | 68.8 score on a scale |
| Group TX (Telehealth Exercise) | Knee Injury and Osteoarthritis Outcome Score | Sports and Recreation Week-8 | 47.2 score on a scale |
| Group TX (Telehealth Exercise) | Knee Injury and Osteoarthritis Outcome Score | Symptoms Baseline | 59.7 score on a scale |
| Group TX (Telehealth Exercise) | Knee Injury and Osteoarthritis Outcome Score | Sports and Recreation Week-14 | 42.8 score on a scale |
| Group TX (Telehealth Exercise) | Knee Injury and Osteoarthritis Outcome Score | Activity of Daily Living Baseline | 72.1 score on a scale |
| Group TX (Telehealth Exercise) | Knee Injury and Osteoarthritis Outcome Score | Quality Of Life Baseline | 45.8 score on a scale |
| Group TX (Telehealth Exercise) | Knee Injury and Osteoarthritis Outcome Score | Pain Week-14 | 63.8 score on a scale |
| Group TX (Telehealth Exercise) | Knee Injury and Osteoarthritis Outcome Score | Quality Of Life Week-8 | 49 score on a scale |
| Group TX (Telehealth Exercise) | Knee Injury and Osteoarthritis Outcome Score | Activity of Daily Living Week-8 | 72.6 score on a scale |
| Group TX (Telehealth Exercise) | Knee Injury and Osteoarthritis Outcome Score | Quality Of Life Week-14 | 52.1 score on a scale |
| Group TX (Telehealth Exercise) | Knee Injury and Osteoarthritis Outcome Score | Pain Baseline | 61.3 score on a scale |
| Group TMX (Telehealth Exercise and Mindfulness) | Knee Injury and Osteoarthritis Outcome Score | Quality Of Life Week-14 | 52.6 score on a scale |
| Group TMX (Telehealth Exercise and Mindfulness) | Knee Injury and Osteoarthritis Outcome Score | Pain Baseline | 57.7 score on a scale |
| Group TMX (Telehealth Exercise and Mindfulness) | Knee Injury and Osteoarthritis Outcome Score | Pain Week-8 | 61.8 score on a scale |
| Group TMX (Telehealth Exercise and Mindfulness) | Knee Injury and Osteoarthritis Outcome Score | Pain Week-14 | 64.2 score on a scale |
| Group TMX (Telehealth Exercise and Mindfulness) | Knee Injury and Osteoarthritis Outcome Score | Symptoms Baseline | 59.4 score on a scale |
| Group TMX (Telehealth Exercise and Mindfulness) | Knee Injury and Osteoarthritis Outcome Score | Symptoms Week-8 | 59.9 score on a scale |
| Group TMX (Telehealth Exercise and Mindfulness) | Knee Injury and Osteoarthritis Outcome Score | Symptoms Week-14 | 62.1 score on a scale |
| Group TMX (Telehealth Exercise and Mindfulness) | Knee Injury and Osteoarthritis Outcome Score | Activity of Daily Living Baseline | 63 score on a scale |
| Group TMX (Telehealth Exercise and Mindfulness) | Knee Injury and Osteoarthritis Outcome Score | Activity of Daily Living Week-8 | 68.2 score on a scale |
| Group TMX (Telehealth Exercise and Mindfulness) | Knee Injury and Osteoarthritis Outcome Score | Activity of Daily Living Week-14 | 68.5 score on a scale |
| Group TMX (Telehealth Exercise and Mindfulness) | Knee Injury and Osteoarthritis Outcome Score | Sports and Recreation Baseline | 37.4 score on a scale |
| Group TMX (Telehealth Exercise and Mindfulness) | Knee Injury and Osteoarthritis Outcome Score | Sports and Recreation Week-8 | 40.6 score on a scale |
| Group TMX (Telehealth Exercise and Mindfulness) | Knee Injury and Osteoarthritis Outcome Score | Sports and Recreation Week-14 | 45.3 score on a scale |
| Group TMX (Telehealth Exercise and Mindfulness) | Knee Injury and Osteoarthritis Outcome Score | Quality Of Life Baseline | 41.1 score on a scale |
| Group TMX (Telehealth Exercise and Mindfulness) | Knee Injury and Osteoarthritis Outcome Score | Quality Of Life Week-8 | 48.5 score on a scale |
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
Time frame: baseline, 8-week, 14-week
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Group TX (Telehealth Exercise) | Numeric Rating Scale - Nominated Activity | Baseline | 6.1 score on a scale |
| Group TX (Telehealth Exercise) | Numeric Rating Scale - Nominated Activity | Week-8 | 5.1 score on a scale |
| Group TX (Telehealth Exercise) | Numeric Rating Scale - Nominated Activity | Week-14 | 4.8 score on a scale |
| Group TMX (Telehealth Exercise and Mindfulness) | Numeric Rating Scale - Nominated Activity | Baseline | 6.5 score on a scale |
| Group TMX (Telehealth Exercise and Mindfulness) | Numeric Rating Scale - Nominated Activity | Week-8 | 5.2 score on a scale |
| Group TMX (Telehealth Exercise and Mindfulness) | Numeric Rating Scale - Nominated Activity | Week-14 | 4.8 score on a scale |
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).
Time frame: baseline, 8-week
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Group TX (Telehealth Exercise) | Pain Catastrophizing Scale | Baseline | 3.5 score on a scale |
| Group TX (Telehealth Exercise) | Pain Catastrophizing Scale | Week-8 | 3.4 score on a scale |
| Group TMX (Telehealth Exercise and Mindfulness) | Pain Catastrophizing Scale | Baseline | 3.9 score on a scale |
| Group TMX (Telehealth Exercise and Mindfulness) | Pain Catastrophizing Scale | Week-8 | 3.1 score on a scale |
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
Time frame: baseline, 8-week
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Group TX (Telehealth Exercise) | Pain DETECT | Baseline | 9.8 score on a scale |
| Group TX (Telehealth Exercise) | Pain DETECT | Week-8 | 9.4 score on a scale |
| Group TMX (Telehealth Exercise and Mindfulness) | Pain DETECT | Baseline | 8.5 score on a scale |
| Group TMX (Telehealth Exercise and Mindfulness) | Pain DETECT | Week-8 | 7.6 score on a scale |
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.
Time frame: baseline, 8-week, 14-week
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Group TX (Telehealth Exercise) | Pain, Enjoyment, General Activity Scale | Baseline | 4.9 score on a scale |
| Group TX (Telehealth Exercise) | Pain, Enjoyment, General Activity Scale | Week-8 | 4 score on a scale |
| Group TX (Telehealth Exercise) | Pain, Enjoyment, General Activity Scale | Week-14 | 3.9 score on a scale |
| Group TMX (Telehealth Exercise and Mindfulness) | Pain, Enjoyment, General Activity Scale | Baseline | 5.4 score on a scale |
| Group TMX (Telehealth Exercise and Mindfulness) | Pain, Enjoyment, General Activity Scale | Week-8 | 3.9 score on a scale |
| Group TMX (Telehealth Exercise and Mindfulness) | Pain, Enjoyment, General Activity Scale | Week-14 | 3.4 score on a scale |
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.
Time frame: 8-week, 14-week
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Group TX (Telehealth Exercise) | Participant Global Impression of Change | Week-8 | 2.2 score on a scale |
| Group TX (Telehealth Exercise) | Participant Global Impression of Change | Week-14 | 1.4 score on a scale |
| Group TMX (Telehealth Exercise and Mindfulness) | Participant Global Impression of Change | Week-8 | 2.4 score on a scale |
| Group TMX (Telehealth Exercise and Mindfulness) | Participant Global Impression of Change | Week-14 | 2.2 score on a scale |
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
Time frame: baseline, 8-week, 14-week
Population: One participant in TX group and four participants in TMX Group were lost to follow-up
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Group TX (Telehealth Exercise) | Patient Global Assessment of Osteoarthritis | Baseline | 59.8 score on a scale |
| Group TX (Telehealth Exercise) | Patient Global Assessment of Osteoarthritis | Week-8 | 64.5 score on a scale |
| Group TX (Telehealth Exercise) | Patient Global Assessment of Osteoarthritis | Week-14 | 60.2 score on a scale |
| Group TMX (Telehealth Exercise and Mindfulness) | Patient Global Assessment of Osteoarthritis | Baseline | 63.7 score on a scale |
| Group TMX (Telehealth Exercise and Mindfulness) | Patient Global Assessment of Osteoarthritis | Week-8 | 65.7 score on a scale |
| Group TMX (Telehealth Exercise and Mindfulness) | Patient Global Assessment of Osteoarthritis | Week-14 | 68.7 score on a scale |
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
Time frame: baseline, 8-week, 14-week
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Group TX (Telehealth Exercise) | Patient Health Questionnaire 8-item | Baseline | 4.6 score on a scale |
| Group TX (Telehealth Exercise) | Patient Health Questionnaire 8-item | Week-8 | 3.7 score on a scale |
| Group TX (Telehealth Exercise) | Patient Health Questionnaire 8-item | Week-14 | 3.9 score on a scale |
| Group TMX (Telehealth Exercise and Mindfulness) | Patient Health Questionnaire 8-item | Baseline | 3 score on a scale |
| Group TMX (Telehealth Exercise and Mindfulness) | Patient Health Questionnaire 8-item | Week-8 | 3.9 score on a scale |
| Group TMX (Telehealth Exercise and Mindfulness) | Patient Health Questionnaire 8-item | Week-14 | 4.1 score on a scale |
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.
Time frame: baseline, 8-week
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Group TX (Telehealth Exercise) | Widespread Pain Index Symptom Severity Scale | Baseline | 3.9 score on a scale |
| Group TX (Telehealth Exercise) | Widespread Pain Index Symptom Severity Scale | Week-8 | 4.1 score on a scale |
| Group TMX (Telehealth Exercise and Mindfulness) | Widespread Pain Index Symptom Severity Scale | Baseline | 3.1 score on a scale |
| Group TMX (Telehealth Exercise and Mindfulness) | Widespread Pain Index Symptom Severity Scale | Week-8 | 3.7 score on a scale |
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
Time frame: baseline, 8-week
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
Time frame: baseline, 8-week
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
Time frame: baseline
Other Pre-specified
Conditioned Pain Modulation [OPTIONAL IN-PERSON VISIT]
a test of descending pain modulation
Time frame: baseline, 8-week
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
Time frame: baseline
Other Pre-specified
Exercise Induced Hypoalgesia [OPTIONAL IN-PERSON VISIT]
a test of change in pain sensitivity after a bout of exercise
Time frame: baseline, 8-week
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
Time frame: baseline
Other Pre-specified
Isometric Knee Extensor Force [OPTIONAL IN-PERSON VISIT]
knee extensor isometric muscle strength
Time frame: baseline, 8-week
Other Pre-specified
Isometric Knee Flexor Force [OPTIONAL IN-PERSON VISIT]
knee flexor isometric muscle strength
Time frame: baseline, 8-week
Other Pre-specified
Mechanical Temporal Summation [OPTIONAL IN-PERSON VISIT]
a test of central pain sensitization
Time frame: baseline, 8-week
Other Pre-specified
Pressure Pain Threshold [OPTIONAL IN-PERSON VISIT]
a test of pain sensitivity
Time frame: baseline, 8-week
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
Time frame: baseline, 8-week
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
Time frame: baseline, 8-week
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
Time frame: 8-week
Other Pre-specified
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
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.
Time frame: Weekly for 14-weeks