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Clinical Trial Summary

Accumulating evidence supports that more pain, whether measured by number of pain sites or pain severity, is associated with poorer cognitive function and mobility, and fall risk in older persons. Tai Chi which holistically integrates physical and cognitive functions offers the possibility not only of alleviating pain but also improving attention and mobility in the many older adults who have chronic multisite pain. This proposed full-size randomized controlled Tai Chi trial is a direct extension of our previous work examining chronic pain, attention demands, mobility and falls in the older population, and is built on the investigators' National Institute on Aging-supported Tai Chi feasibility and acceptability pilot study among older adults with multisite pain and risk for falls. The goal of this single-blinded randomized controlled trial is to examine the effects of a 24-week Tai Chi intervention on chronic pain, cognition, mobility, fear of falling, and rates of total and injurious falls in older adults with multisite pain and at risk for falls. The results of this study will provide a foundation to establish the clinical significance of Tai Chi in the management of chronic multisite pain and to explore the mechanisms through which Tai Chi improves chronic pain symptoms and lowers rates of total and injurious falls in at-risk older adults.


Clinical Trial Description

The investigators will measure pain severity, pain interference, pain-related biomarkers, cognition, physical function, single-task and dual-task gait, and fear of falling pre- and post-intervention in 200 older adults (Tai Chi: N=100, and exercise control: N=100). The investigators will also measure rates of total and injurious falls in the 12 months during and following the intervention. The primary aims are: 1. to examine the effects of Tai Chi on pain symptoms in older adults with multisite pain. It is hypothesized that older adults in the Tai Chi intervention will have less pain, measured as pain severity and interference, than those in the light physical exercise control group; 2. to examine the effects of Tai Chi on fear of falling and rates of total and injurious falls in older adults with multisite pain. It is hypothesized that older adults in the Tai Chi intervention will have greater improvements in fear of falling scores and fewer total and injurious falls than those in the light exercise control group in the 48 weeks during and after the Tai Chi intervention. The secondary/exploratory aims are: 3. to examine the effects of Tai Chi on pain-related biomarkers in older adults with multisite pain. It is hypothesized that older adults in the Tai Chi intervention will have lower levels of pain-related biomarkers, than those in the light physical exercise control group; 4. to examine the role of improvement in chronic pain in the reduction of fall rates by Tai Chi in older adults with multisite pain. It is hypothesized that the reductions in fall rates are dependent on the improvement in pain symptoms in older adults with chronic multisite pain; 5. to examine the roles of improvements in cognition and mobility in the reduction of fall rates by Tai Chi in older adults with multisite pain. It is hypothesized that the reductions in chronic pain and in fall rates are mediated by the changes in cognition and mobility in older adults with chronic multisite pain. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03705598
Study type Interventional
Source University of Massachusetts, Boston
Contact
Status Not yet recruiting
Phase N/A
Start date July 1, 2024
Completion date March 31, 2029

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