Recruiting

Telehealth Exercise

Sponsor:

Boston University Charles River Campus

Code:

NCT06684587

Conditions

Knee Osteoarthritis

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Interventions

Exercise Program

Mindful Exercise

Study Details

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

Study ID

NCT06684587

Start date

Apr 24, 2025

Status verified date

Sep, 2026

Completion date

Aug, 2027

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

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 Design

Enrollment

66 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

Exercise Program

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

Mindful Exercise

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

Primary outcome measure

  • Recruitment Rate [ Time Frame: Throughout the recruitment process; up to 12 months from the start of the study ]
  • Attendance [ Time Frame: Throughout the intervention period (over 10-weeks) ]
  • Retention Rate [ Time Frame: Post-intervention visit (10-week) ]
  • Adverse and serious adverse events [ Time Frame: From first intervention session to week 22 ]

Central Contacts and Locations

Central contacts

Deepak Kumar, PT, PhD

617-358-3037kumard@bu.edu

Rhodora Torres, MS

617-358-8142torresrt@bu.edu

Locations

Boston University

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Deepak Kumar, PT, PhD

kumard@Bu.edu

Principal Investigator:

Deepak Kumar, PT, PhD

More Information

Sponsor

Boston University Charles River Campus

Last update posted

Sep 4, 2026

Last verified

Sep, 2026

Keywords

  • Telehealth
  • Exercise
  • Mindfulness
  • Pain
  • Feasibility

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Boston University Charles River Campus on 2026-09-04.