Telehealth Exercise and Mindfulness for Pain in Osteoarthritis (TEMPO)

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

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.

Study Overview

• Status: Completed
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Behavioral: Exercise; Behavioral: Mindful Exercise program

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.

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Movement and Applied Imaging Lab, Boston University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Behavioral: 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.
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

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
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
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
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
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 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
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Boston University Charles River Campus
• Investigators: Principal Investigator: Deepak Kumar, PT, PhD, Boston University

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2022
• Primary Completion (Actual): June 6, 2023
• Study Completion (Actual): July 3, 2023

Study Registration Dates

• First Submitted: August 25, 2022
• First Submitted That Met QC Criteria: August 29, 2022
• First Posted (Actual): September 1, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: November 26, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: pain; exercise; mindfulness; feasibility; telehealth
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis
• Other Study ID Numbers: 6492; 6492E (Other Identifier: BU CRC IRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Requests will be considered on an individual basis

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No