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

NCT06684587 | Recruiting DMC

• 1 other identifier: 7510
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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). This RCT will be fully digital with all recruitment, assessments, and intervention being conducted remotely.

Conditions

Knee Osteoarthritis

Keywords

Telehealth; Exercise; Mindfulness; Pain; Feasibility

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (8)

• Knee Injury and Osteoarthritis Outcome Score

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

• Numeric Rating Scale - Nominated Activity

  Weekly for 22 weeks

• Participant Feedback Survey

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

• Satisfaction Scale

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

• Pain Catastrophizing Scale

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

Other Outcomes (17)

• 7-meter Walk Test

  Baseline,10-week

• Pain, Enjoyment, General Activity Scale

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

• Patient Global Assessment of Osteoarthritis

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

Study Arms (2)

Group TX (Telehealth Exercise)

ACTIVE COMPARATOR

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

Group TMX (Telehealth Exercise and Mindfulness)

EXPERIMENTAL

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

Interventions

Exercise Program BEHAVIORAL

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

Group TX (Telehealth Exercise)

Mindful Exercise BEHAVIORAL

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

Group TMX (Telehealth Exercise and Mindfulness)

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston University Charles River Campus: lead

Study Sites (1)

Boston University

Boston, Massachusetts, 02215, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 39021877 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee; Motor Activity; Pain

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Deepak Kumar, PT, PhD

CONTACT

617-358-3037; kumard@bu.edu

Ehyun Kim, MS

CONTACT

617-358-8142; kimawc@bu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Parallel-arm randomized controlled trial

Study Record Dates

• First Submitted: November 7, 2024
• First Posted: November 12, 2024
• Study Start: April 24, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)