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

September 16, 2026 updated by: Deepak Kumar, Boston University Charles River Campus

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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and 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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
66

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Deepak Kumar, PT, PhD
  • Phone Number: 617-358-3037
  • Email: kumard@bu.edu

Study Contact Backup

  • Name: Rhodora Torres, MS
  • Phone Number: 617-358-8142
  • Email: torresrt@bu.edu

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Boston University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Recruitment Rate
Time Frame: Throughout the recruitment process; up to 12 months from the start of the study
Proportion of participants that are recruited for the study
Throughout the recruitment process; up to 12 months from the start of the study
Attendance
Time Frame: Throughout the intervention period (over 10-weeks)
Proportion of sessions attended.
Throughout the intervention period (over 10-weeks)
Retention Rate
Time Frame: Post-intervention visit (10-week)
Proportion of participants who complete patient-reported outcome surveys.
Post-intervention visit (10-week)
Adverse and serious adverse events
Time Frame: From first intervention session to week 22
# of intervention related adverse or serious adverse events
From first intervention session to week 22

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Knee Injury and Osteoarthritis Outcome Score
Time Frame: Baseline, 5-week, 10-week, 16-week, 22-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.
Baseline, 5-week, 10-week, 16-week, 22-week
Numeric Rating Scale - Nominated Activity
Time Frame: Weekly for 22 weeks
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
Time Frame: 5-week, Post-intervention visit (10-week), Follow-up visit (22-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).
5-week, Post-intervention visit (10-week), Follow-up visit (22-week)
Satisfaction Scale
Time Frame: Post-intervention visit (10-week), Follow-up visit (22-week)
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
Time Frame: Baseline, 5-week, 10-week, 16-week, 22-week
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
Time Frame: 5-week, 10-week, 16-week, 22-week
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
Time Frame: Baseline, 10-week, 22-week
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
Time Frame: Baseline, 10-week, 22-week
13-item tool that assesses all five mindfulness factors: Allowance, Boundlessness, Open-Heartedness, Insight, and Presence.
Baseline, 10-week, 22-week

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
7-meter Walk Test
Time Frame: Baseline,10-week
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
Time Frame: Baseline, 5-week, 10-week, 16-week, 22-week
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
Time Frame: Baseline, 5-week, 10-week, 16-week, 22-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.
Baseline, 5-week, 10-week, 16-week, 22-week
Treatment History
Time Frame: Baseline, 5-week, 10-week, 16-week, 22-week
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
Time Frame: Baseline, 5-week, 10-week, 16-week, 22-week
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
Time Frame: Baseline, 5-week, 10-week, 22-week
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
Time Frame: Baseline, 10-week, 22-week
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
Time Frame: Baseline, 5-week, 10-week, 16-week, 22-week
Assess the number of painful, aching or stiffed joints.
Baseline, 5-week, 10-week, 16-week, 22-week
Arthritis Self Efficacy Scale
Time Frame: Baseline, 10-week, 22-week
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
Time Frame: Baseline,10-week
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
Time Frame: Baseline,10-week
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
Time Frame: Baseline,10-week
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
Time Frame: Weekly for 22-weeks
# of days and # of times/day of analgesic medication use for knee pain
Weekly for 22-weeks
Weekly strengthening exercise
Time Frame: Weekly for 22-weeks
# of minutes of strengthening exercise per day of the week
Weekly for 22-weeks
Weekly aerobic exercise
Time Frame: Weekly for 22-weeks
# of minutes of aerobic exercise per day of the week
Weekly for 22-weeks
Weekly mindfulness practice (only for mindful exercise group)
Time Frame: Weekly for 22-weeks (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
Time Frame: Baseline,10-week
9-question survey tool that integrates individual-level biological and behavioral factors
Baseline,10-week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boston University Charles River Campus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 24, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 7, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 9, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 12, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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