Tai Chi Intervention for Geriatric Pain Syndrome
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorUniversity of Massachusetts, Boston
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Light physical exercise
BehavioralOne 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
BehavioralOne 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.
Treatment groups
266 Participants
are divided into 2 treatment groupsGroup A: Light physical exercisePlacebo comparator 1 intervention
Group B: Tai ChiActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Pain severity
Pain severity will be assessed using the Brief Pain Inventory.
Time frame
6 months2
Pain interference
Pain interference will be assessed using the Brief Pain Inventory.
Time frame
6 months3
Fear of falling
Fear of falling will be assessed using the Tinetti Falls Efficacy Scale.
Time frame
6 months4
Rate of falls
Rate of falls will be assessed using monthly falls calendar postcards.
Time frame
12 monthsSecondary outcomes
1
C-reactive protein
Plasma levels of C-reactive protein will be measured using enzyme-linked immunosorbent assays.
Time frame
6 months2
Interleukin 6
Plasma levels of interleukin 6 will be measured using enzyme-linked immunosorbent assays.
Time frame
6 months3
Tumor necrosis factor alpha
Plasma levels of tumor necrosis factor alpha will be measured using enzyme-linked immunosorbent assays.
Time frame
6 months4
Nuclear factor kappa B
Plasma levels of nuclear factor kappa B will be measured using enzyme-linked immunosorbent assays.
Time frame
6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Massachusetts, Boston
Lead sponsor
Brigham and Women's Hospital
Collaborator
Beth Israel Deaconess Medical Center
Collaborator
Source ClinicalTrials.gov