Telehealth Exercise and Mindfulness for Pain in Osteoarthritis - Stage 1B (TEMPO-1B)

Telehealth Exercise and Mindfulness for Pain in Osteoarthritis: A Stage 1B Feasibility Study

The goal of this randomized controlled trial (RCT) is to test the feasibility of an 10-week telehealth mindful exercise intervention compared to a telehealth exercise only intervention for people with knee osteoarthritis (OA). This RCT will be fully digital with all recruitment, assessments, and intervention being conducted remotely.

Study Overview

• Status: Recruiting
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Behavioral: Exercise Program; Behavioral: Mindful Exercise

Detailed Description

In this RCT, 66 adults with knee osteoarthritis will be assigned to either an exercise arm or mindful exercise arm. Both interventions will be delivered via videoconferencing in a group setting. In both groups, participants will receive a supervised session twice a week for 10 weeks. Participants will also receive a home program. During the study period, participants will be asked to remotely complete brief surveys every week and longer surveys on pain, function, mood, and other symptoms at baseline, week 5, week 10, week 16, and week 22. These surveys will be about pain, function, mood, and other symptoms. Participants will complete digital wearable-sensor based assessments at baseline and week 10. Participants will also be asked to complete brief surveys each week during the study. Feasibility of the intervention will be determined post-intervention by outcome measures such as recruitment rate, retention rate, and adherence.

• Study Type: Interventional
• Enrollment (Estimated): 66
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Deepak Kumar, PT, PhD; Phone Number: 617-358-3037; Email: kumard@bu.edu
• Study Contact Backup: Name: Ehyun Kim, MS; Phone Number: 617-358-8142; Email: kimawc@bu.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Boston University
      • Principal Investigator: Deepak Kumar, PT, PhD
      • Contact: Deepak Kumar, PT, PhD; Email: kumard@Bu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 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, no morning knee stiffness or 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 an 11-point numeric rating scale over last 7 days, at least 2 weeks apart
• 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 group-based, supervised exercise session twice a week for 10 weeks along with a structured home exercise program. These sessions will be delivered via Boston University HIPAA-compliant Zoom videoconferencing software.	Behavioral: Exercise Program; In this 10-week intervention, participants will be given strengthening exercises and neuromuscular re-education exercises.
Experimental: Group TMX (Telehealth Exercise and Mindfulness); Participants in this group will receive a group-based, supervised, integrated mindfulness and exercise program twice a week for 10 weeks along with a structured home program. Similar to the exercise intervention, these sessions will be delivered via Boston University HIPAA-compliant Zoom videoconferencing software.	Behavioral: Mindful Exercise; In this 10-week intervention, mindfulness meditation will be integrated with strengthening and neuromuscular exercises recommended for knee osteoarthritis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment Rate	Proportion of participants that are recruited for the study	Throughout the recruitment process; up to 12 months from the start of the study
Attendance	Proportion of sessions attended.	Throughout the intervention period (over 10-weeks)
Retention Rate	Proportion of participants who complete patient-reported outcome surveys.	Post-intervention visit (10-week)
Adverse and serious adverse events	# of intervention related adverse or serious adverse events	From first intervention session to week 22

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, 5-week, 10-week, 16-week, 22-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.	Weekly for 22 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).	5-week, Post-intervention visit (10-week), Follow-up visit (22-week)
Satisfaction Scale	Custom 4-item (0-10 Likert scale) to determine satisfaction with individual components of the intervention.	Post-intervention visit (10-week), Follow-up visit (22-week)
Pain Catastrophizing Scale	13-item self-report measure designed to assess catastrophic thinking related to pain among adults with or without chronic pain. Each item is rated on a 5-point scale: 0 (Not at all) to 4 (all the time).	Baseline, 5-week, 10-week, 16-week, 22-week
Participant Global Impression of Change	Participant's rating of change in condition on a 15-point scale. Higher scores represent improvement and lower scores represent worsening or no change in symptoms.	5-week, 10-week, 16-week, 22-week
Tampa Scale of Kinesiophobia	17-item self-report checklist with a 4-point Likert scale (1 - Strongly disagree; 2 - Disagree; 3 - Agree; 4 - Strongly agree) to assess one's fear of movement. Scoring of items 4, 8, 12, and 16 must be reversed, where "strongly disagree" is 4 points, "disagree" is 3 points, "agree" is 2 points, and "strongly agree" is 1 point. Sum up the scores for all 17 items to obtain the total raw score, ranging from 17 to 68 points. Higher total scores indicate an increasing degree of kinesiophobia, with 17 indicating no kinesiophobia or negligible fear of movement and 68 representing the highest possible level of kinesiophobia.	Baseline, 10-week, 22-week
Global Mindfulness Scale	13-item tool that assesses all five mindfulness factors: Allowance, Boundlessness, Open-Heartedness, Insight, and Presence.	Baseline, 10-week, 22-week

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
7-meter Walk Test	Functional test that measures comfortable walking speed as participant walks for two laps of a 7-meter path for a total walking distance of 28-meters. Participants will performance this visit remotely at their home.	Baseline,10-week
Pain, Enjoyment, General Activity Scale	3-item scale assessing pain intensity and interference. The response range is 0-10; the score of Pain, Enjoyment, General Activity Scale is the mean of the three individual item scores. Higher scores represent worse pain and pain-related interference.	Baseline, 5-week, 10-week, 16-week, 22-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, 5-week, 10-week, 16-week, 22-week
Treatment History	A survey that collects information about the treatments the individual has undertaken for their knee osteoarthritis	Baseline, 5-week, 10-week, 16-week, 22-week
Widespread Pain Index Symptom Severity Scale	Self-reported outcome 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, 5-week, 10-week, 16-week, 22-week
Generalized Anxiety Disorder 7-item	7-item questionnaire for anxiety, with scoring from 0-3 on each item. A total score of 0-4 indicates minimal anxiety; 5-9 for mild anxiety; 10-14 for moderate anxiety; and 15-21 for severe anxiety	Baseline, 5-week, 10-week, 22-week
Patient Health Questionnaire 8-item	8-item scale assessing depression symptoms. Each question is scored from 0 to 3, where higher scores indicate higher frequency of experiencing depressive symptoms. The total score is the sum value of individual questions. Higher total scores indicate greater severity of depression.	Baseline, 10-week, 22-week
Homunculus	Assess the number of painful, aching or stiffed joints.	Baseline, 5-week, 10-week, 16-week, 22-week
Arthritis Self Efficacy Scale	Self-reported outcome assessing 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, 10-week, 22-week
Fear Avoidance Beliefs Questionnaire - Physical Activity	Self-reported outcome assessing 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 the summation of each item scores. Higher total scores indicate greater fear of physical activity.	Baseline,10-week
Daily life gait speed	Participants will be asked to wear a single inertial sensor that will be placed on their lower back for a period of 7 days. Mean daily walking in meters per second speed over 7 days will be extracted	Baseline,10-week
Daily life gait speed variability	Participants will be asked to wear a single inertial sensor that will be placed on their lower back for a period of 7 days. Standard deviation of daily walking speed in meters per second over 7 days will be extracted	Baseline,10-week
Weekly medication use	# of days and # of times/day of analgesic medication use for knee pain	Weekly for 22-weeks
Weekly strengthening exercise	# of minutes of strengthening exercise per day of the week	Weekly for 22-weeks
Weekly aerobic exercise	# of minutes of aerobic exercise per day of the week	Weekly for 22-weeks
Weekly mindfulness practice (only for mindful exercise group)	# of minutes of mindfulness practice per day of the week	Weekly for 22-weeks (only for mindful exercise group)
Whole Person Health Index	9-question survey tool that integrates individual-level biological and behavioral factors	Baseline,10-week

Collaborators and Investigators

• Sponsor: Boston University Charles River Campus

Publications and helpful links

General Publications

• Shah N, Morone N, Kim E, Ellis TD, Cohn E, LaValley MP, Kumar D. Telehealth mindful exercise for people with knee osteoarthritis: A decentralized feasibility randomized controlled trial. Osteoarthr Cartil Open. 2024 Jun 19;6(3):100494. doi: 10.1016/j.ocarto.2024.100494. eCollection 2024 Sep.

Study record dates

Study Major Dates

• Study Start (Actual): April 24, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: November 7, 2024
• First Submitted That Met QC Criteria: November 9, 2024
• First Posted (Actual): November 12, 2024

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: April 30, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Exercise; Feasibility; Pain; Mindfulness; Telehealth
• Additional Relevant MeSH Terms: Neurologic Manifestations; Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Pain; Osteoarthritis, Knee; Motor Activity; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Therapeutics; Physical Therapy Modalities; Patient Care; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Physical Conditioning, Human; Exercise; Resistance Training
• Other Study ID Numbers: 7510

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
• product manufactured in and exported from the U.S.: No