Tai Chi Intervention for Geriatric Pain Syndrome

Not Applicable

Not yet recruiting

• Conditions: Falls; Chronic Pain
• Interventions: Behavioral: Light physical exercise; Behavioral: Tai Chi

• Registration Number: NCT03705598
• Lead Sponsor: University of Massachusetts, Boston

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.

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, mid-point, 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 Timeline

• Study First Submitted: 2018-05-23
• Study First Submitted QC: 2018-10-10
• Study First Posted: 2018-10-15
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-10
• Last Update Posted: 2024-07-11
• Study Start: 2025-04-01
• Primary Completion: 2030-03-31
• Study Completion: 2030-03-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 266

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 moderate to severe cognitive impairment (Mini-Mental State Examination (MMSE) score <18)
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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Light physical exercise	Light physical exercise	Usual-pace walking, strength exercise, stretching exercise, and balance exercise.
Tai Chi	Tai Chi	Tai Chi walking drills and Yang-style Tai Chi 8 forms.

Primary Outcome Measures

Name	Time	Method
Pain severity	24 weeks	Pain severity will be assessed using the Brief Pain Inventory.
Pain interference	24 weeks	Pain interference will be assessed using the Brief Pain Inventory.
Rate of falls	48 weeks	Rate of falls will be assessed using monthly falls calendar postcards.
Fear of falling	24 weeks	Fear of falling will be assessed using the Tinetti Falls Efficacy Scale.

Secondary Outcome Measures

Name	Time	Method
Interleukin 6	24 weeks	Plasma levels of interleukin 6 will be measured using enzyme-linked immunosorbent assays.
C-reactive protein	24 weeks	Plasma levels of C-reactive protein will be measured using enzyme-linked immunosorbent assays.
Tumor necrosis factor alpha	24 weeks	Plasma levels of tumor necrosis factor alpha will be measured using enzyme-linked immunosorbent assays.
Beta endorphin	24 weeks	Plasma levels of beta endorphin will be measured using an enzyme-linked immunosorbent assay.
Attention	24 weeks	Attention will be assessed by using 4 subscales of the Test of Everyday Attention.
Executive function	24 weeks	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).
Single-task stride time	24 weeks	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.
Single-task swing time	24 weeks	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.
Nuclear factor kappa B	24 weeks	Plasma levels of nuclear factor kappa B will be measured using enzyme-linked immunosorbent assays.
Single-task stride length	24 weeks	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.
Dual-task stride time	24 weeks	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.
Dual-task stride length	24 weeks	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.
Free-living physical activity	24 weeks	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.
Dual-task swing time	24 weeks	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.
Sleep time	24 weeks	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.
Sleep efficiency	24 weeks	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).