Chronic Pain, Falls
Conditions
Keywords
Tai Chi, Chronic Pain, Falls, Older Adults
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 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.
Interventions
BEHAVIORALLight 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.
BEHAVIORALTai 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.
Sponsors
University of Massachusetts, Boston
Brigham and Women's Hospital
Beth Israel Deaconess Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain severity | 6 months | Pain severity will be assessed using the Brief Pain Inventory. |
| Pain interference | 6 months | Pain interference will be assessed using the Brief Pain Inventory. |
| Fear of falling | 6 months | Fear of falling will be assessed using the Tinetti Falls Efficacy Scale. |
| Rate of falls | 12 months | Rate of falls will be assessed using monthly falls calendar postcards. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| C-reactive protein | 6 months | Plasma levels of C-reactive protein will be measured using enzyme-linked immunosorbent assays. |
| Interleukin 6 | 6 months | Plasma levels of interleukin 6 will be measured using enzyme-linked immunosorbent assays. |
| Tumor necrosis factor alpha | 6 months | Plasma levels of tumor necrosis factor alpha will be measured using enzyme-linked immunosorbent assays. |
| Nuclear factor kappa B | 6 months | Plasma levels of nuclear factor kappa B will be measured using enzyme-linked immunosorbent assays. |
| Beta endorphin | 6 months | Plasma levels of beta endorphin will be measured using an enzyme-linked immunosorbent assay. |
| Attention | 6 months | Attention will be assessed by using 4 subscales of the Test of Everyday Attention. |
| Executive function | 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). |
| Physical Function | 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. |
| Single-task stride time | 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. |
| Single-task stride length | 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. |
| Single-task swing time | 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. |
| Dual-task stride length | 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. |
| Dual-task stride time | 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. |
| Free-living physical activity | 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. |
| Dual-task swing time | 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. |
| Sleep time | 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. |
| Sleep efficiency | 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). |
Outcome results
None listed