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Completed

NCT Number: NCT03086772

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

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.

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Key information

Conditions

Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Massachusetts, Boston

Boston, Massachusetts, 02125, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tai Chi

Behavioral

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 Exercise

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. Physical function

    Time frame: Before and after the 12-week intervention period

    Physical function was measured by using the Short Physical Performance Battery (SPPB)

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

University of Massachusetts, Boston

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Mar 22, 2017
Registry last updated
Oct 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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