Telehealth Exercise and Mindfulness for Pain in Osteoarthritis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Telehealth Exercise and Mindfulness for Pain in Osteoarthritis: A Feasibility Study

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Behavioral: Mindful Exercise program
* Behavioral: Exercise


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel-arm randomized controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group TX (Telehealth Exercise)<br>Participants in this group will receive a supervised and group-based exercise program once a week for 8 weeks via telehealth. | Behavioral: Exercise<br>* 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.<br>|
| Experimental: Group TMX (Telehealth Exercise and Mindfulness)<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment Rate | Proportion of participants that are recruited for the study | through the recruitment process, up to 6 months from the start of the study | 
| Attendance | Proportion of participants that attended the intervention sessions | post-intervention (at 12-weeks) | 
| Retention Rate | Proportion of participants who complete patient-reported outcome surveys | post-intervention visit (at the end of 12-weeks) | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 7-point scale. Higher scores represent improvement and lower scores represent worsening or no change in symptoms | 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 | 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 | questionnaire assessing depression symptoms. each question is scored from 0 to 3 where higher scores indicate higher frequency of experiencing depressive symptoms. the sum value of individual questions is the total score. 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 | 
| 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 | 
| 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 | 
| Fear Avoidance Beliefs Questionnaire - Physical Activity | 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. Higher total scores indicate greater fear of physical activity | baseline, 8-week | 
| Arthritis Self Efficacy Scale | confidence in one's capacity to function despite pain. Scores range from 10 (very uncertain) to 100 (very certain). Higher scores indicate greater self-efficacy to manage osteoarthritis. | baseline, 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). higher total scores indicate greater self-efficacy to manage one's chronic pain. | 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 | 
| Satisfaction Scale | custom 4-item (0-10 likert scale) to determine satisfaction with individual components of the intervention | 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 | 
| Individual Interviews with 20 participants [ONLY FOR SELECT PARTICIPANTS] | interviews to explore acceptability of the mindful exercise intervention | 8-week | 
| Participant feedback survey | feedback on the intervention and interventionists | 8-week | 
| Weekly exercise log | log of exercise and aerobic activity | Weekly for 14-weeks | 
| Weekly mindful exercise log | log of mindfulness practice | 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 | 
| Demographics | a survey that collects information to help understand the background characteristics of the individual such as race, ethnicity, education, employment status, and family income | baseline | 
| Comorbidities | a survey that collects information on presence of other medical health conditions including heart disease, diabetes, etc. | baseline | 
| Treatment History | a survey that collects information about the treatments the individual has undertaken for their knee osteoarthritis | baseline | 
| Phenx Access Health Technology Survey | a survey that collects information about access the individual has to health technology | baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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exercise, mindfulness, pain, feasibility, telehealth