Chronic PainNCT03086772
Effects of Tai Chi on Multisite Pain and Brain Functions in Older Adults
A study testing Tai Chi and Light Exercise in people with Chronic Pain, run by University of Massachusetts, Boston at 1 site in United States.
Trial summary
The main purpose of this randomized controlled trial was to assess the feasibility and acceptability of a 12-week Tai Chi program for community-dwelling older adults with chronic multisite pain and a history of falling. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Tai Chi and Light Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Age of 65 years and older
- Multisite (2 or more sites) musculoskeletal pain
- At least one fall in the past year, or currently on an assistive device
- A sedentary lifestyle
- Be able to walk 20-feet without personal assistance
- Be able to communicate in English.
Who cannot join
- Regular Tai Chi practice
- Unstable cardiac disease
- Stroke
- Rheumatoid arthritis
- Degenerative neuromuscular disease
- Parkinson's disease
- Terminal disease
- Dementing illness
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Massachusetts, Boston
Boston, Massachusetts, 02125
About this study
The main purpose of this randomized controlled trial was to assess the feasibility and acceptability of a 12-week Tai Chi program for community-dwelling older adults with chronic multisite pain and a history of falling. In addition, the investigators examined the effects of Tai Chi on pain characteristics, cognition, physical function, gait mobility, levels of pain-related biomarkers, fear of falling and rate of falls in these older adults.
Read the detailed description
Older adults aged ≥65 years with multisite pain who reported falling in the past year or current use of an assistive device were recruited from Boston area communities. Participants were randomized to either a Tai Chi (N=28) or a light physical exercise (N=26) program, offered twice weekly for 12 weeks. The primary outcomes were feasibility and acceptability of the 12-week Tai Chi/light exercise program. Secondary outcomes included pain characteristics (pain severity and pain interference), cognition (attention and executive function), physical function (walking speed, strength, and balance), gait mobility (singe-task and dual-task gait), levels of pain-related markers (C-reactive protein, interleukin 6, tumor necrosis factor alpha, and beta endorphin), fear of falling, and rate of falls.
- Conditions
- Chronic Pain
- Being tested
- Tai Chi, Light Exercise
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tai ChiBehavioural
Individuals in the Tai Chi intervention group will participate in a 12-week Tai Chi program (one hour per class, two classes per week, plus home practice for 12 weeks) led by an experienced Tai Chi Instructor, assisted by an undergraduate research assistant.
Light ExerciseBehavioural
Individuals in the exercise control group will meet for a twice weekly class involving walking, weight training, stretching and health education (one hour per class, two classes per week for 12 weeks, taught by a trained graduate research assistant, assisted by an undergraduate research assistant.
| Study group | Role | What they receive |
|---|---|---|
| Tai Chi | Experimental | Individuals in the Tai Chi intervention group participated in a 12-week Tai Chi program. Receives: Behavioral: Tai Chi |
| Light Exercise | Active comparator | Individuals in the exercise control group performed a 12-week light exercise program. Receives: Behavioral: Light Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility and acceptability of the 12-week Tai Chi program
Feasibility and acceptability were evaluated by adherence, attendance, optimal program components, and safety.
Measured: Over the 12-week intervention period
Secondary outcomes (7)
Pain characteristics
Pain severity and interference were evaluated by using the Brief Pain Inventory (BPI) questionnaire.
Measured: Before and after the 12-week intervention period
Cognition
Attention was evaluated by using the Test of Everyday Attention (TEA) questionnaire. Executive function was evaluated by using the Trailmaking A and B tests questionnaire.
Measured: Before and after the 12-week intervention period
Physical function
Physical function was measured by using the Short Physical Performance Battery (SPPB)
Measured: Before and after the 12-week intervention period
Gait mobility
Single-task and dual-task gait function was determined by using the PKMAS software and Zeno walkway.
Measured: Before and after the 12-week intervention period
Pain-related biomarkers
Levels of inflammatory markers and beta endorphin were determined by using biochemistry assays.
Measured: Before and after the 12-week intervention period
Fear of falling
Fear of falling was measured using the Tinetti Falls Effi- cacy Scale.
Measured: Before and after the 12-week intervention period
Rate of falls
Rate of falls were recorded by using monthly fall calendars.
Measured: Over the 12-week intervention and 6 months following the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2017
- Study startMay 2014
- Primary completionApr 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Participant
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Boston
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Tongjian You, University of Massachusetts, Boston
- Investigators
- Tongjian You, PhD, Principal investigator, University of Massachusetts, BostonSuzanne Leveille, PhD, Principal investigator, University of Massachusetts, Boston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03086772
- Sponsor's protocol ID
- R21AG043883
- Other IDs
- R21AG043883
- Status last verified
- Oct 2018
- First submitted
- 4 Jun 2015
- Last updated
- 25 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
You T, Ogawa EF, Thapa S, Cai Y, Zhang H, Nagae S, Yeh GY, Wayne PM, Shi L, Leveille SG. Tai Chi for older adults with chronic multisite pain: a randomized controlled pilot study. Aging Clin Exp Res. 2018 Nov;30(11):1335-1343. doi: 10.1007/s40520-018-0922-0. Epub 2018 Mar 6.
PubMed 29512041
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Tai Chi on Multisite Pain and Brain Functions in Older Adults
- ClinicalTrials.gov ID
- NCT03086772
- Acronym / sponsor ID
- R21AG043883
- Conditions
- Chronic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University of Massachusetts, BostonUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- May 2014
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 22 Mar 2017 (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.
The main purpose of this randomized controlled trial was to assess the feasibility and acceptability of a 12-week Tai Chi program for community-dwelling older adults with chronic multisite pain and a history of falling. In addition, the investigators examined the effects of Tai Chi on pain characteristics, cognition, physical function, gait mobility, levels of pain-related biomarkers, fear of falling and rate of falls in these older adults.
Detailed description
Older adults aged ≥65 years with multisite pain who reported falling in the past year or current use of an assistive device were recruited from Boston area communities. Participants were randomized to either a Tai Chi (N=28) or a light physical exercise (N=26) program, offered twice weekly for 12 weeks. The primary outcomes were feasibility and acceptability of the 12-week Tai Chi/light exercise program. Secondary outcomes included pain characteristics (pain severity and pain interference), cognition (attention and executive function), physical function (walking speed, strength, and balance), gait mobility (singe-task and dual-task gait), levels of pain-related markers (C-reactive protein, interleukin 6, tumor necrosis factor alpha, and beta endorphin), fear of falling, and rate of falls.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tai Chi | Experimental | Behavioral: Tai ChiIndividuals in the Tai Chi intervention group participated in a 12-week Tai Chi program. |
| Light Exercise | Active comparator | Behavioral: Light ExerciseIndividuals in the exercise control group performed a 12-week light exercise program. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Age of 65 years and older
- Multisite (2 or more sites) musculoskeletal pain
- At least one fall in the past year, or currently on an assistive device
- A sedentary lifestyle
- Be able to walk 20-feet without personal assistance
Key exclusion criteria (8 listed)
- Regular Tai Chi practice
- Unstable cardiac disease
- Stroke
- Rheumatoid arthritis
- Degenerative neuromuscular 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 |
|---|---|---|
| Tai ChiIndividuals in the Tai Chi intervention group will participate in a 12-week Tai Chi program (one hour per class, two classes per week, plus home practice for 12 weeks) led by an experienced Tai Chi Instructor, assisted by an undergraduate research assistant. | Behavioural | Tai Chi |
| Light ExerciseIndividuals in the exercise control group will meet for a twice weekly class involving walking, weight training, stretching and health education (one hour per class, two classes per week for 12 weeks, taught by a trained graduate research assistant, assisted by an undergraduate research assistant. | Behavioural | Light Exercise |
Primary outcome
Feasibility and acceptability of the 12-week Tai Chi program
Time frame: Over the 12-week intervention period
Feasibility and acceptability were evaluated by adherence, attendance, optimal program components, and safety.
7 secondary outcomes
Pain characteristics
Time frame: Before and after the 12-week intervention period
Cognition
Time frame: Before and after the 12-week intervention period
Physical function
Time frame: Before and after the 12-week intervention period
Gait mobility
Time frame: Before and after the 12-week intervention period
Pain-related biomarkers
Time frame: Before and after the 12-week intervention period
Fear of falling
Time frame: Before and after the 12-week intervention period
Rate of falls
Time frame: Over the 12-week intervention and 6 months following the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2018.
- Results publication: PubMed 29512041You T, Ogawa EF, Thapa S, Cai Y, Zhang H, Nagae S, Yeh GY, Wayne PM, Shi L, Leveille SG. Tai Chi for older adults with chronic multisite pain: a randomized controlled pilot study. Aging Clin Exp Res. 2018 Nov;30(11):1335-1343. doi: 10.1007/s40520-018-0922-0. Epub 2018 Mar 6.
- 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. This study is not recruiting at the moment.
Tongjian You, PhD principal investigator
University of Massachusetts, Boston
Suzanne Leveille, 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 Tai Chi and Light Exercise in people with Chronic Pain, 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 6 inclusion and 8 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: finished, as of the sponsor's last update on 25 Oct 2018. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility and acceptability of the 12-week Tai Chi program (time frame: Over the 12-week intervention period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03086772, which also lists 1 linked publication.
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 25 Oct 2018.