Chronic PainNCT03705598
Tai Chi Intervention for Geriatric Pain Syndrome
A study testing Light physical exercise and Tai Chi in people with Chronic Pain and Falls, run by University of Massachusetts, Boston at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Chronic Pain, Falls
- What is being tested?
- Light physical exercise and Tai Chi
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 266 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2026to 31 Jul 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
HELP Study Office and Lab
Boston, Massachusetts, 02125
Tongjian You, PhD, 6172875934, tongjian.you@umb.edu
Mekhala Rao, MPH, 6172876297, mekhala.rao@umb.edu
About this study
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.
Read the 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.
- Conditions
- Chronic Pain, Falls
- Being tested
- Light physical exercise, Tai Chi
- Keywords
- Tai Chi, Chronic Pain, Falls, Older Adults
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Light physical exerciseBehavioural
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.
Tai ChiBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Light physical exercise | Placebo comparator | Usual-pace walking, strength exercise, stretching exercise, and balance exercise. Receives: Behavioral: Light physical exercise |
| Tai Chi | Active comparator | Tai Chi walking drills and Yang-style Tai Chi 8 forms. Receives: Behavioral: Tai Chi |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain severity
Pain severity will be assessed using the Brief Pain Inventory.
Measured: 6 months
Pain interference
Pain interference will be assessed using the Brief Pain Inventory.
Measured: 6 months
Fear of falling
Fear of falling will be assessed using the Tinetti Falls Efficacy Scale.
Measured: 6 months
Rate of falls
Rate of falls will be assessed using monthly falls calendar postcards.
Measured: 12 months
Secondary outcomes (17)
C-reactive protein
Plasma levels of C-reactive protein will be measured using enzyme-linked immunosorbent assays.
Measured: 6 months
Interleukin 6
Plasma levels of interleukin 6 will be measured using enzyme-linked immunosorbent assays.
Measured: 6 months
Tumor necrosis factor alpha
Plasma levels of tumor necrosis factor alpha will be measured using enzyme-linked immunosorbent assays.
Measured: 6 months
Nuclear factor kappa B
Plasma levels of nuclear factor kappa B will be measured using enzyme-linked immunosorbent assays.
Measured: 6 months
Beta endorphin
Plasma levels of beta endorphin will be measured using an enzyme-linked immunosorbent assay.
Measured: 6 months
Attention
Attention will be assessed by using 4 subscales of the Test of Everyday Attention.
Measured: 6 months
Executive function
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).
Measured: 6 months
Physical Function
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.
Measured: 6 months
Single-task stride time
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.
Measured: 6 months
Single-task stride length
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.
Measured: 6 months
Single-task swing time
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.
Measured: 6 months
Dual-task stride length
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.
Measured: 6 months
Dual-task stride time
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.
Measured: 6 months
Free-living physical activity
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.
Measured: 6 months
Dual-task swing time
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.
Measured: 6 months
Sleep time
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.
Measured: 6 months
Sleep efficiency
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).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2018
- Study start1 Oct 2026
- Primary completion30 Apr 2030 (estimated)
- Study completion31 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 266 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Boston
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tongjian You, University of Massachusetts, Boston
- Investigators
- Tongjian You, PhD, Principal investigator, University of Massachusetts, Boston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03705598
- Sponsor's protocol ID
- 297908
- Status last verified
- Oct 2026
- First submitted
- 23 May 2018
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tai Chi Intervention for Geriatric Pain Syndrome
- ClinicalTrials.gov ID
- NCT03705598
- Acronym / sponsor ID
- 297908
- Conditions
- Chronic Pain, Falls
- Keywords
- Tai Chi, Chronic Pain, Falls, Older Adults
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 266 participants (estimated)
- Lead sponsor
- University of Massachusetts, BostonUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital, Beth Israel Deaconess Medical Center
- Study start
- 1 Oct 2026 (actual)
- Primary completion
- 30 Apr 2030 (estimated)
- Study completion
- 31 Jul 2030 (estimated)
- First posted
- 15 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Light physical exercise | Placebo comparator | Behavioral: Light physical exerciseUsual-pace walking, strength exercise, stretching exercise, and balance exercise. |
| Tai Chi | Active comparator | Behavioral: Tai ChiTai Chi walking drills and Yang-style Tai Chi 8 forms. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Light physical exerciseOne 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. | Behavioural | Light physical exercise |
| Tai ChiOne 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. | Behavioural | Tai Chi |
Primary outcome
Pain severity
Time frame: 6 months
Pain severity will be assessed using the Brief Pain Inventory.
Pain interference
Time frame: 6 months
Pain interference will be assessed using the Brief Pain Inventory.
Fear of falling
Time frame: 6 months
Fear of falling will be assessed using the Tinetti Falls Efficacy Scale.
Rate of falls
Time frame: 12 months
Rate of falls will be assessed using monthly falls calendar postcards.
17 secondary outcomes
C-reactive protein
Time frame: 6 months
Interleukin 6
Time frame: 6 months
Tumor necrosis factor alpha
Time frame: 6 months
Nuclear factor kappa B
Time frame: 6 months
Beta endorphin
Time frame: 6 months
Attention
Time frame: 6 months
Executive function
Time frame: 6 months
Physical Function
Time frame: 6 months
Single-task stride time
Time frame: 6 months
Single-task stride length
Time frame: 6 months
Single-task swing time
Time frame: 6 months
Dual-task stride length
Time frame: 6 months
Dual-task stride time
Time frame: 6 months
Free-living physical activity
Time frame: 6 months
Dual-task swing time
Time frame: 6 months
Sleep time
Time frame: 6 months
Sleep efficiency
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tongjian You, PhD principal investigator
University of Massachusetts, Boston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Light physical exercise and Tai Chi in people with Chronic Pain and Falls, run by University of Massachusetts, Boston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tongjian You, PhD (6172875934, Tongjian.you@umb.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain severity (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.