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Knee OsteoarthritisTEMPO-1BNCT06684587

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

A study testing Exercise Program and Mindful Exercise in people with Knee Osteoarthritis, run by Boston University Charles River Campus at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Knee Osteoarthritis
What is being tested?
Exercise Program and Mindful Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
1 siteUnited States
Study dates
24 Apr 2025to Aug 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 16Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Boston University

    Boston, Massachusetts, 02215

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Exercise Program, Mindful Exercise
Keywords
Telehealth, Exercise, Mindfulness, Pain, Feasibility
Medical subject headings
Osteoarthritis, Knee, Motor Activity, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exercise ProgramBehavioural

    In this 10-week intervention, participants will be given strengthening exercises and neuromuscular re-education exercises.

  • Mindful ExerciseBehavioural

    In this 10-week intervention, mindfulness meditation will be integrated with strengthening and neuromuscular exercises recommended for knee osteoarthritis.

Study groups in NCT06684587
Study groupRoleWhat they receive
Group TX (Telehealth Exercise)Active comparatorParticipants 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.
Receives: Behavioral: Exercise Program
Group TMX (Telehealth Exercise and Mindfulness)ExperimentalParticipants 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.
Receives: Behavioral: Mindful Exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recruitment Rate

    Proportion of participants that are recruited for the study

    Measured: Throughout the recruitment process; up to 12 months from the start of the study

  2. Attendance

    Proportion of sessions attended.

    Measured: Throughout the intervention period (over 10-weeks)

  3. Retention Rate

    Proportion of participants who complete patient-reported outcome surveys.

    Measured: Post-intervention visit (10-week)

  4. Adverse and serious adverse events

    # of intervention related adverse or serious adverse events

    Measured: From first intervention session to week 22

Secondary outcomes (8)

  1. 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.

    Measured: Baseline, 5-week, 10-week, 16-week, 22-week

  2. 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.

    Measured: Weekly for 22 weeks

  3. 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).

    Measured: 5-week, Post-intervention visit (10-week), Follow-up visit (22-week)

  4. Satisfaction Scale

    Custom 4-item (0-10 Likert scale) to determine satisfaction with individual components of the intervention.

    Measured: Post-intervention visit (10-week), Follow-up visit (22-week)

  5. 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).

    Measured: Baseline, 5-week, 10-week, 16-week, 22-week

  6. 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.

    Measured: 5-week, 10-week, 16-week, 22-week

  7. 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.

    Measured: Baseline, 10-week, 22-week

  8. Global Mindfulness Scale

    13-item tool that assesses all five mindfulness factors: Allowance, Boundlessness, Open-Heartedness, Insight, and Presence.

    Measured: Baseline, 10-week, 22-week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Nov 2024
  2. Study start24 Apr 2025
  3. Primary completionApr 2027 (estimated)
  4. Study completionAug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Parallel-arm randomized controlled trial
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
66 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06684587
Sponsor's protocol ID
7510
Acronym
TEMPO-1B
Status last verified
Sep 2026
First submitted
7 Nov 2024
Last updated
17 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Requests will be considered on an individual basis

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.

    PubMed 39021877

Questions about this trial

What is this clinical trial studying?

A study testing Exercise Program and Mindful Exercise in people with Knee Osteoarthritis, run by Boston University Charles River Campus at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recruitment Rate (time frame: Throughout the recruitment process; up to 12 months from the start of the study). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06684587, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.

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