Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06384898
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-08
First Post:
2024-03-26
Brief Title:
Remote Tai Chi for Knee Osteoarthritis
Sponsor:
Tufts Medical Center
Organization:
Tufts Medical Center
Study Overview
Official Title:
Remote Tai Chi for Knee Osteoarthritis An Embedded Pragmatic Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TAICHIKNEE
Brief Summary:
The goal of this pragmatic randomized trial is to evaluate the effectiveness of remote Tai Chi to treat knee pain in adults with knee osteoarthritis The main questions the trial aims to answer are
Compared to routine care will patients with Knee OA receiving remote Tai Chi exhibit greater improvement in knee-related pain WOMAC pain score primary outcome pain interference PROMIS-Pain Interference secondary outcome and health-related quality of life at 3 months
Does remote tai chi decreases healthcare utilization and analgesic use over the one-year study period
Researchers will compare remote Tai Chi added to routine care to routine care alone to see if remote tai chi works to treat knee osteoarthritis pain Participants will participate in remotely delivered web-based tai chi sessions twice a week for 12 weeks or will continue to receive routine care Participants will be followed for 12 months after randomization
Compared to routine care will patients with Knee OA receiving remote Tai Chi exhibit greater improvement in knee-related pain WOMAC pain score primary outcome pain interference PROMIS-Pain Interference secondary outcome and health-related quality of life at 3 months
Does remote tai chi decreases healthcare utilization and analgesic use over the one-year study period
Researchers will compare remote Tai Chi added to routine care to routine care alone to see if remote tai chi works to treat knee osteoarthritis pain Participants will participate in remotely delivered web-based tai chi sessions twice a week for 12 weeks or will continue to receive routine care Participants will be followed for 12 months after randomization
Detailed Description:
Investigators will conduct a 12-month embedded pragmatic hybrid type 1 effectiveness-implementation individually randomized group-treatment trial that will compare the effects of a 3-month twice weekly remotely delivered web-based Tai Chi intervention plus routine care versus routine care alone across four health care systems Tufts Medical Center Boston Medical Center University of California Los Angeles Health and Cleveland Clinic in four geographic regions Eastern Massachusetts Southern California Northeast Ohio Cleveland Clinic Southern Florida Cleveland Clinic Investigators will enroll a total of 480 diverse patients with a clinical diagnosis of Knee OA Participants will be evaluated at baseline and 3 months with additional follow-up at 6 and 12 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UH3AT012413 | OTHER_GRANT | National Center for Complementary and Integrative Health | None |