Tai Chi Intervention for Geriatric Pain Syndrome

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Pain; Falls
• Intervention / Treatment: Behavioral: Light physical exercise; Behavioral: Tai Chi

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 266
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. be 65 years or older
2. report chronic multisite (≥2 sites) musculoskeletal pain
3. have had 1 or more falls in the past year or current use of an assistive device (a cane or walker)
4. be able to walk 20 feet without help
5. be able to communicate in English

Exclusion Criteria:

1. actively engage in moderate to vigorous exercise for more than 40 min/week
2. practiced Tai Chi or other mind-body exercise within the past year, or practiced Tai Chi or other mind-body exercise regularly for at least 3 months within the past 5 years
3. have cognitive impairment consistent with dementia (Montreal Cognitive Assessment (MOCA) score < 18 after corrections),
4. have a diagnosis of a disease/condition that would interfere with their study participation (e.g., rheumatoid arthritis, stroke, Parkinson's disease, degenerative neuromuscular disease, unstable cardiac disease, Alzheimer's disease or other dementia, terminal disease)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Light physical exercise; Usual-pace walking, strength exercise, stretching exercise, and balance exercise.	Behavioral: Light physical exercise; 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.
Active Comparator: Tai Chi; 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/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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain severity	Pain severity will be assessed using the Brief Pain Inventory.	6 months
Pain interference	Pain interference will be assessed using the Brief Pain Inventory.	6 months
Fear of falling	Fear of falling will be assessed using the Tinetti Falls Efficacy Scale.	6 months
Rate of falls	Rate of falls will be assessed using monthly falls calendar postcards.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
C-reactive protein	Plasma levels of C-reactive protein will be measured using enzyme-linked immunosorbent assays.	6 months
Interleukin 6	Plasma levels of interleukin 6 will be measured using enzyme-linked immunosorbent assays.	6 months
Tumor necrosis factor alpha	Plasma levels of tumor necrosis factor alpha will be measured using enzyme-linked immunosorbent assays.	6 months
Nuclear factor kappa B	Plasma levels of nuclear factor kappa B will be measured using enzyme-linked immunosorbent assays.	6 months
Beta endorphin	Plasma levels of beta endorphin will be measured using an enzyme-linked immunosorbent assay.	6 months
Attention	Attention will be assessed by using 4 subscales of the Test of Everyday Attention.	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).	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.	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.	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.	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.	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.	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.	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.	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.	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).	6 months

Collaborators and Investigators

• Sponsor: University of Massachusetts, Boston
• Collaborators: Beth Israel Deaconess Medical Center; Brigham and Women's Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): April 30, 2030
• Study Completion (Estimated): July 31, 2030

Study Registration Dates

• First Submitted: May 23, 2018
• First Submitted That Met QC Criteria: October 10, 2018
• First Posted (Actual): October 15, 2018

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Chronic Pain; Older Adults; Tai Chi; Falls
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Chronic Pain; Therapeutics; Mind-Body Therapies; Complementary Therapies; Exercise Movement Techniques; Physical Therapy Modalities; Tai Ji
• Other Study ID Numbers: 297908

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No