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NCT Number: NCT03705598

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.

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Key information

Conditions

Chronic Pain Falls Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • actively engage in moderate to vigorous exercise for more than 40 min/week
  • 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
  • have cognitive impairment consistent with dementia (Montreal Cognitive Assessment (MOCA) score < 18 after corrections),
  • 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)

Treatment and study plan

Light physical exercise

Behavioral

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.

Tai Chi

Behavioral

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.

Primary outcomes

  1. Pain severity

    Time frame: 6 months

    Pain severity will be assessed using the Brief Pain Inventory.

  2. Pain interference

    Time frame: 6 months

    Pain interference will be assessed using the Brief Pain Inventory.

  3. Fear of falling

    Time frame: 6 months

    Fear of falling will be assessed using the Tinetti Falls Efficacy Scale.

  4. Rate of falls

    Time frame: 12 months

    Rate of falls will be assessed using monthly falls calendar postcards.

Secondary outcomes

  1. C-reactive protein

    Time frame: 6 months

    Plasma levels of C-reactive protein will be measured using enzyme-linked immunosorbent assays.

  2. Interleukin 6

    Time frame: 6 months

    Plasma levels of interleukin 6 will be measured using enzyme-linked immunosorbent assays.

  3. Tumor necrosis factor alpha

    Time frame: 6 months

    Plasma levels of tumor necrosis factor alpha will be measured using enzyme-linked immunosorbent assays.

  4. Nuclear factor kappa B

    Time frame: 6 months

    Plasma levels of nuclear factor kappa B will be measured using enzyme-linked immunosorbent assays.

  5. Beta endorphin

    Time frame: 6 months

    Plasma levels of beta endorphin will be measured using an enzyme-linked immunosorbent assay.

  6. Attention

    Time frame: 6 months

    Attention will be assessed by using 4 subscales of the Test of Everyday Attention.

  7. Executive function

    Time frame: 6 months

    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).

  8. Physical Function

    Time frame: 6 months

    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.

  9. Single-task stride time

    Time frame: 6 months

    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.

  10. Single-task stride length

    Time frame: 6 months

    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.

  11. Single-task swing time

    Time frame: 6 months

    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.

  12. Dual-task stride length

    Time frame: 6 months

    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.

  13. Dual-task stride time

    Time frame: 6 months

    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.

  14. Free-living physical activity

    Time frame: 6 months

    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.

  15. Dual-task swing time

    Time frame: 6 months

    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.

  16. Sleep time

    Time frame: 6 months

    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.

  17. Sleep efficiency

    Time frame: 6 months

    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).

Sponsors and collaborators

Lead sponsor

University of Massachusetts, Boston

Other

Collaborators

  • Beth Israel Deaconess Medical Center
  • Brigham and Women's Hospital

Registry information

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Oct 15, 2018
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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