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

Primary Purpose

Chronic Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tai Chi
Light Exercise
Sponsored by
University of Massachusetts, Boston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Massachusetts, Boston

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Tai Chi

Light Exercise

Arm Description

Individuals in the Tai Chi intervention group participated in a 12-week Tai Chi program.

Individuals in the exercise control group performed a 12-week light exercise program.

Outcomes

Primary Outcome Measures

Feasibility and acceptability of the 12-week Tai Chi program
Feasibility and acceptability were evaluated by adherence, attendance, optimal program components, and safety.

Secondary Outcome Measures

Pain characteristics
Pain severity and interference were evaluated by using the Brief Pain Inventory (BPI) questionnaire.
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.
Physical function
Physical function was measured by using the Short Physical Performance Battery (SPPB)
Gait mobility
Single-task and dual-task gait function was determined by using the PKMAS software and Zeno walkway.
Pain-related biomarkers
Levels of inflammatory markers and beta endorphin were determined by using biochemistry assays.
Fear of falling
Fear of falling was measured using the Tinetti Falls Effi- cacy Scale.
Rate of falls
Rate of falls were recorded by using monthly fall calendars.

Full Information

First Posted
June 4, 2015
Last Updated
October 23, 2018
Sponsor
University of Massachusetts, Boston
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT03086772
Brief Title
Effects of Tai Chi on Multisite Pain and Brain Functions in Older Adults
Official Title
Effects of Tai Chi on Multisite Pain and Brain Functions in Older Adults
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
April 2017 (Actual)
Study Completion Date
April 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Massachusetts, Boston
Collaborators
National Institute on Aging (NIA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tai Chi
Arm Type
Experimental
Arm Description
Individuals in the Tai Chi intervention group participated in a 12-week Tai Chi program.
Arm Title
Light Exercise
Arm Type
Active Comparator
Arm Description
Individuals in the exercise control group performed a 12-week light exercise program.
Intervention Type
Behavioral
Intervention Name(s)
Tai Chi
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Light Exercise
Intervention Description
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 Outcome Measure Information:
Title
Feasibility and acceptability of the 12-week Tai Chi program
Description
Feasibility and acceptability were evaluated by adherence, attendance, optimal program components, and safety.
Time Frame
Over the 12-week intervention period
Secondary Outcome Measure Information:
Title
Pain characteristics
Description
Pain severity and interference were evaluated by using the Brief Pain Inventory (BPI) questionnaire.
Time Frame
Before and after the 12-week intervention period
Title
Cognition
Description
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.
Time Frame
Before and after the 12-week intervention period
Title
Physical function
Description
Physical function was measured by using the Short Physical Performance Battery (SPPB)
Time Frame
Before and after the 12-week intervention period
Title
Gait mobility
Description
Single-task and dual-task gait function was determined by using the PKMAS software and Zeno walkway.
Time Frame
Before and after the 12-week intervention period
Title
Pain-related biomarkers
Description
Levels of inflammatory markers and beta endorphin were determined by using biochemistry assays.
Time Frame
Before and after the 12-week intervention period
Title
Fear of falling
Description
Fear of falling was measured using the Tinetti Falls Effi- cacy Scale.
Time Frame
Before and after the 12-week intervention period
Title
Rate of falls
Description
Rate of falls were recorded by using monthly fall calendars.
Time Frame
Over the 12-week intervention and 6 months following the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tongjian You, PhD
Organizational Affiliation
University of Massachusetts, Boston
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Suzanne Leveille, PhD
Organizational Affiliation
University of Massachusetts, Boston
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Massachusetts, Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02125
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29512041
Citation
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.
Results Reference
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Effects of Tai Chi on Multisite Pain and Brain Functions in Older Adults

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