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

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

54

Phase

  • 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

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
Intervention / Treatment
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

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

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

University of Massachusetts, Boston

Collaborators

National Institute on Aging (NIA)

Investigators

  • 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

May 1, 2014

Primary Completion (Actual)

April 1, 2017

Study Completion (Actual)

April 1, 2017

Study Registration Dates

First Submitted

June 4, 2015

First Submitted That Met QC Criteria

March 15, 2017

First Posted (Actual)

March 22, 2017

Study Record Updates

Last Update Posted (Actual)

October 25, 2018

Last Update Submitted That Met QC Criteria

October 23, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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