An interventional study of Light physical exercise and Tai Chi in Chronic Pain and Falls, sponsored by University of Massachusetts, Boston. Recruiting at 1 site in United States. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-10-07.
Sponsored by University of Massachusetts, Boston · Not applicable, Interventional, and Treatment
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 the investigators' 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 studies 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 fall rate 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 fall rate in at-risk older adults.
The investigators will measure pain severity, pain interference, and fear of falling at baseline, mid-point (3-month), and post-intervention (6-month), as well as rate of falls during the intervention (0- to 6-month) and the 6-month follow-up period (month 6 to month 12) in 266 older adults (Tai Chi: N=133, and light physical exercise control: N=133). In addition, they will measure pain-related biomarkers, cognition, single-task and dual-task gait function, free-living physical activity, and sleep at baseline and post-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 rate of falls in older adults with multisite pain. It is hypothesized that older adults in the Tai Chi intervention will have less fear of falling and fewer falls than those in the light physical exercise control group. 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 Tai Chi intervention will have greater reductions in levels of pain-related biomarkers and and beta endorphin, than those in the light physical exercise control group; 4. to examine the roles of changes in pain symptoms in the change of fall rate by Tai Chi in older adults with multisite pain. It is hypothesized that the effect of Tai Chi on the reduced fall rate will be explained in part by improvements in pain symptoms in older adults with multisite pain; 5. to examine the roles of changes in cognition and cognitive motor function in the change of fall rate by Tai Chi in older adults with multisite pain. It is hypothesized that the reduced fall rate in the Tai Chi group will be mediated by changes in cognition and cognitive-motor function in older adults with multisite pain.
3,227 studies on the registry are indexed under Chronic Pain; 729 are open to participants now.
This study's planned enrollment of 266 is above the median of 60 across 2,388 interventional studies indexed under Chronic Pain.
Browse Chronic Pain studies →University of Massachusetts, Boston is the lead sponsor of 23 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Usual-pace walking, strength exercise, stretching exercise, and balance exercise.
Behavioral: Light physical exercise
Tai Chi walking drills and Yang-style Tai Chi 8 forms.
Behavioral: Tai Chi
One hour each session, two sessions each week, for 6 months. Each session will be structured into three 15-minute segments (including warm-up activities/balance exercise/walking, upper and lower body strength exercise/walking, and stretching exercise/balance exercise/walking, respectively), each ending with a short break to record the Borg Rating of Perceived Exertion (RPE), followed by a 5-minute break time or cool-down/wrap-up session. The session will be taught by a certified exercise physiologist and a research assistant.
One hour each session, two sessions each week, for 6 months. Each session will be structured into three 15-minute segments (including warm-up activities/balance exercise/breathing exercise, Tai Chi walking drills, and Tai Chi 8-form, respectively), each ending with a short break to record the RPE, and followed by a 5-minute break or cool-down/wrap-up session. The session will be taught by an experienced Tai Chi instructor and a research assistant.
Pain severity
Pain severity will be assessed using the Brief Pain Inventory.
Time frame: 6 months
Pain interference
Pain interference will be assessed using the Brief Pain Inventory.
Time frame: 6 months
Fear of falling
Fear of falling will be assessed using the Tinetti Falls Efficacy Scale.
Time frame: 6 months
Rate of falls
Rate of falls will be assessed using monthly falls calendar postcards.
Time frame: 12 months
C-reactive protein
Plasma levels of C-reactive protein will be measured using enzyme-linked immunosorbent assays.
Time frame: 6 months
Interleukin 6
Plasma levels of interleukin 6 will be measured using enzyme-linked immunosorbent assays.
Time frame: 6 months
Tumor necrosis factor alpha
Plasma levels of tumor necrosis factor alpha will be measured using enzyme-linked immunosorbent assays.
Time frame: 6 months
Nuclear factor kappa B
Plasma levels of nuclear factor kappa B will be measured using enzyme-linked immunosorbent assays.
Time frame: 6 months
Beta endorphin
Plasma levels of beta endorphin will be measured using an enzyme-linked immunosorbent assay.
Time frame: 6 months
Attention
Attention will be assessed by using 4 subscales of the Test of Everyday Attention.
Time frame: 6 months
Executive function
Executive function will be assessed using the Trailmaking test, which requires the connection of sequentially numbered circles (part A), and the connection of circles marked by numbers and letters in alternating sequence (part B).
Time frame: 6 months
Physical Function
Physical function will be measured by the well-validated Short Physical Performance Battery (SPPB), a composite measure of mobility including standing balance, usual-paced 4-meter walk, and time needed for 5 repeated chair stands performed without using arms.
Time frame: 6 months
Single-task stride time
Gait will be assessed using a sensored gait mat that has embedded pressure sensors distributed throughout the mat. The mat measures location and timing of individual steps, which then can be used to calculate stride time.
Time frame: 6 months
Single-task stride length
Gait will be assessed using a sensored gait mat that has embedded pressure sensors distributed throughout the mat. The mat measures location and timing of individual steps, which then can be used to calculate stride length.
Time frame: 6 months
Single-task swing time
Gait will be assessed using a sensored gait mat that has embedded pressure sensors distributed throughout the mat. The mat measures location and timing of individual steps, which then can be used to calculate swing time.
Time frame: 6 months
Dual-task stride length
Gait will be assessed using a sensored gait mat that has embedded pressure sensors distributed throughout the mat. During the dual-task walking, the participants will perform 2 sets of cognitive challenges in random order: serial subtractions 3 and 5 from 100. The mat measures location and timing of individual steps, which then can be used to calculate stride length.
Time frame: 6 months
Dual-task stride time
Gait will be assessed using a sensored gait mat that has embedded pressure sensors distributed throughout the mat. During the dual-task walking, the participants will perform 2 sets of cognitive challenges in random order: serial subtractions 3 and 5 from 100. The mat measures location and timing of individual steps, which then can be used to calculate stride time.
Time frame: 6 months
Free-living physical activity
Participants will be instructed to wear an accelerometer (GT3X+, ActiGraph, LLC) on their non-dominant wrist for 7 days. The manufacturer's software, ActiLife, will be used to process data. Physical activity counts (per minute per day over the 7 days) will be used as a measure of total physical activity.
Time frame: 6 months
Dual-task swing time
Gait will be assessed using a sensored gait mat that has embedded pressure sensors distributed throughout the mat. During the dual-task walking, the participants will perform 2 sets of cognitive challenges in random order: serial subtractions 3 and 5 from 100. The mat measures location and timing of individual steps, which then can be used to calculate swing time.
Time frame: 6 months
Sleep time
Participants will be instructed to wear an accelerometer (GT3X+, ActiGraph, LLC) on their non-dominant wrist for 7 days. The manufacturer's software, ActiLife, will be used to process data to calculate total daily sleep time.
Time frame: 6 months
Sleep efficiency
Participants will be instructed to wear an accelerometer (GT3X+, ActiGraph, LLC) on their non-dominant wrist for 7 days. The manufacturer's software, ActiLife, will be used to process data to calculate percent sleep during in-bed intervals (sleep efficiency).
Time frame: 6 months
Plan to share: No
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University of Massachusetts, Boston