Effects of Tai Chi on Multisite Pain and Brain Functions in Older Adults

October 23, 2018 updated by: Tongjian You, University of Massachusetts, Boston
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
54

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02125
        • University of Massachusetts, Boston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Regular Tai Chi practice
  • Unstable cardiac disease
  • Stroke
  • Rheumatoid arthritis
  • Degenerative neuromuscular disease
  • Parkinson's disease
  • Terminal disease
  • Dementing illness

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Tai Chi
Individuals in the Tai Chi intervention group participated in a 12-week Tai Chi program.
Behavioral: Tai Chi
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.
Active Comparator: Light Exercise
Individuals in the exercise control group performed a 12-week light exercise program.
Behavioral: Light Exercise
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Over the 12-week intervention period

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pain characteristics
Time Frame: Before and after the 12-week intervention period
Pain severity and interference were evaluated by using the Brief Pain Inventory (BPI) questionnaire.
Before and after the 12-week intervention period
Cognition
Time Frame: Before and after the 12-week intervention period
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.
Before and after the 12-week intervention period
Physical function
Time Frame: Before and after the 12-week intervention period
Physical function was measured by using the Short Physical Performance Battery (SPPB)
Before and after the 12-week intervention period
Gait mobility
Time Frame: Before and after the 12-week intervention period
Single-task and dual-task gait function was determined by using the PKMAS software and Zeno walkway.
Before and after the 12-week intervention period
Pain-related biomarkers
Time Frame: Before and after the 12-week intervention period
Levels of inflammatory markers and beta endorphin were determined by using biochemistry assays.
Before and after the 12-week intervention period
Fear of falling
Time Frame: Before and after the 12-week intervention period
Fear of falling was measured using the Tinetti Falls Effi- cacy Scale.
Before and after the 12-week intervention period
Rate of falls
Time Frame: Over the 12-week intervention and 6 months following the intervention
Rate of falls were recorded by using monthly fall calendars.
Over the 12-week intervention and 6 months following the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Massachusetts, Boston

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Aging (NIA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Tongjian You, PhD, University of Massachusetts, Boston
  • Principal Investigator: Suzanne Leveille, PhD, University of Massachusetts, Boston

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 4, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 15, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 22, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 25, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 23, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R21AG043883 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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