Clinical trial NCT03705598: Tai Chi Intervention for Geriatric Pain Syndrome
Official title: Tai Chi Intervention for Geriatric Pain Syndrome
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Pain
Falls
Lead sponsor: University of Massachusetts, Boston
Sponsor class: OTHER
Collaborators: name: Brigham and Women's Hospital
name: Beth Israel Deaconess Medical Center
First posted: 2018-10-15
Enrollment: 266
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Pain severity
timeFrame: 24 weeks
measure: Pain interference
timeFrame: 24 weeks
measure: Fear of falling
timeFrame: 24 weeks
measure: Rate of falls
timeFrame: 48 weeks
Secondary outcomes:
measure: C-reactive protein
timeFrame: 24 weeks
measure: Interleukin 6
timeFrame: 24 weeks
measure: Tumor necrosis factor alpha
timeFrame: 24 weeks
measure: Nuclear factor kappa B
timeFrame: 24 weeks
measure: Beta endorphin
timeFrame: 24 weeks
measure: Attention
timeFrame: 24 weeks
measure: Executive function
timeFrame: 24 weeks
measure: Single-task stride time
timeFrame: 24 weeks
measure: Single-task stride length
timeFrame: 24 weeks
measure: Single-task swing time
timeFrame: 24 weeks
measure: Dual-task stride time
timeFrame: 24 weeks
measure: Dual-task stride length
timeFrame: 24 weeks
measure: Dual-task swing time
timeFrame: 24 weeks
measure: Free-living physical activity
timeFrame: 24 weeks
measure: Sleep time
timeFrame: 24 weeks
measure: Sleep efficiency
timeFrame: 24 weeks
Other outcomes:
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