Tai Chi Intervention for Geriatric Pain Syndrome

NCT03705598 | Not Yet Recruiting DMC

• 1 other identifier: 297908
• Study Type: interventional
• Target: 266
• Locations: 0 countries
• Sites: N/A

Brief 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 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.

Conditions

Chronic Pain; Falls

Keywords

Tai Chi; Chronic Pain; Falls; Older Adults

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (17)

• C-reactive protein

  6 months

• Interleukin 6

  6 months

• Tumor necrosis factor alpha

  6 months

• Nuclear factor kappa B

  6 months

• Beta endorphin

  6 months

Study Arms (2)

Light physical exercise

PLACEBO COMPARATOR

Usual-pace walking, strength exercise, stretching exercise, and balance exercise.

Behavioral: Light physical exercise

Tai Chi

ACTIVE COMPARATOR

Tai Chi walking drills and Yang-style Tai Chi 8 forms.

Behavioral: Tai Chi

Interventions

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.

Light physical exercise

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.

Tai Chi

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Brigham and Women's Hospital: collaborator
• Beth Israel Deaconess Medical Center: collaborator
• University of Massachusetts, Boston: lead

MeSH Terms

Conditions

Chronic Pain

Interventions

Tai Ji

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 23, 2018
• First Posted: October 15, 2018
• Study Start: June 1, 2026
• Primary Completion (Estimated): April 30, 2030
• Study Completion (Estimated): July 31, 2030
• Last Updated: June 1, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share