Telehealth Exercise and Mindfulness for Pain in Osteoarthritis

NCT05524116 | Completed Results

• 1 other identifier: 6492
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

This is a parallel-arm mixed-methods randomized controlled trial to investigate the feasibility of telehealth delivered mindful exercise vs. usual exercise interventions for people with knee osteoarthritis.

Conditions

Knee Osteoarthritis

Keywords

telehealth; exercise; mindfulness; pain; feasibility

Outcome Measures

Primary Outcomes (5)

• Recruitment

  Number of participants that are randomized for the study

  through the recruitment process, up to 6 months from the start of the study

• Attendance

  Proportion of sessions attended

  post-intervention (at 8-weeks)

• Retention Rate

  Proportion of participants who complete patient-reported outcome surveys

  post-intervention visit (at the end of 8-weeks)

• 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)

  8-week

• Satisfaction Scale

  Custom 4-item (0-10 scale) to determine satisfaction with individual components of the intervention (i.e.,, exercise, mindfulness, telehealth, and overall satisfaction). There are 4 items and each item is scored separately. Higher scores for each item mean greater satisfaction for that dimension.

  8-week

Secondary Outcomes (13)

• Knee Injury and Osteoarthritis Outcome Score

  baseline, 8-week, 14-week

• Pain, Enjoyment, General Activity Scale

  baseline, 8-week, 14-week

• Numeric Rating Scale - Nominated Activity

  baseline, 8-week, 14-week

• Participant Global Impression of Change

  8-week, 14-week

• Patient Global Assessment of Osteoarthritis

  baseline, 8-week, 14-week

Other Outcomes (16)

• Arthritis - Rapid Estimate of Adult Literacy in Medicine (A-REALM)

  baseline

• Sit to Stand Test [OPTIONAL IN-PERSON VISIT]

  baseline, 8-week

• 6-minute Walk Test [OPTIONAL IN-PERSON VISIT]

  baseline, 8-week

Study Arms (2)

Group TX (Telehealth Exercise)

ACTIVE COMPARATOR

Participants in this group will receive a supervised and group-based exercise program once a week for 8 weeks via telehealth.

Behavioral: Exercise

Group TMX (Telehealth Exercise and Mindfulness)

EXPERIMENTAL

Participants in this group will receive a supervised, group-based integrated mindfulness and exercise program once a week for 8 weeks via telehealth.

Behavioral: Mindful Exercise program

Interventions

Mindful Exercise program BEHAVIORAL

In this 8-week intervention, components of Mindful Based Stress Reduction Program will be integrated with strengthening and neuromuscular exercises recommended for knee osteoarthritis. The goal of this program is to train participants how to be mindful during their exercises.

Group TMX (Telehealth Exercise and Mindfulness)

Exercise BEHAVIORAL

In this 8-week intervention, participants will be given recommended strengthening and neuromuscular exercises for knee osteoarthritis. Participants in both the intervention and control group will receive these exercises.

Group TX (Telehealth Exercise)

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, 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 a 11-point numeric rating scale during previous week
• 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)

Movement and Applied Imaging Lab, Boston University

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Motor Activity; Pain

Interventions

Exercise

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)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Limitations and Caveats

There are limitations to consider while interpreting the findings of our study. 1. All outcomes are participant-reported which can introduce bias as we did not include any objective measures (e.g., physical performance). 2. There was lack of diversity in race, education, socioeconomic status, and technological abilities, which limits the external validity of our findings

Results Point of Contact

• Title: Dr. Deepak Kumar
• Organization: Boston University

kumard@bu.edu

3026901455

Study Officials

• Deepak Kumar, PT, PhD

  Boston University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: For some of the outcomes that are not patient-reported, researchers collecting the at the post-intervention visit timepoint will be blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Parallel-arm randomized controlled trial

Study Record Dates

• First Submitted: August 25, 2022
• First Posted: September 1, 2022
• Study Start: October 4, 2022
• Primary Completion: June 6, 2023
• Study Completion: July 3, 2023
• Last Updated: January 16, 2025
• Results First Posted: January 16, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)