RECRUITING

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

Conditions

Knee Osteoarthritis Telehealth Exercise Mindfulness Pain Feasibility

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-04-24

Study Completion:2027-08

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06684587

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.

Ages Eligible for Study:50 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Deepak Kumar, PT, PhD

CONTACT

617-358-3037

kumard@bu.edu

Ehyun Kim, MS

CONTACT

617-358-8142

kimawc@bu.edu

Study Locations (Sites)

Boston University

Boston, Massachusetts, 02215

United States

Collaborators and Investigators

Sponsor: Boston University Charles River Campus

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 Registration Dates

Study Start Date2025-04-24

Study Completion Date2027-08

Study Record Updates

Study Start Date2025-04-24

Study Completion Date2027-08

Terms related to this study

Keywords Provided by Researchers

Telehealth
Exercise
Mindfulness
Pain
Feasibility

Additional Relevant MeSH Terms

Knee Osteoarthritis