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Effects of Tai Chi on Multisite Pain and Falls in Older Adults

Primary Purpose

Chronic Pain, Falls

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Light physical exercise
Tai Chi
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:

  1. Aged 65 years and older
  2. have chronic multisite (2 or more sites) musculoskeletal pain (lasting 3 or more months in the previous year and present in the previous month)
  3. reports at least 1 fall in the previous year or currently using an assistive device to walk (cane or walker)
  4. Able to walk 20-feet without personal assistance
  5. has never practiced Tai Chi or other mind-body exercise in the previous 5 years
  6. able to communicate in English

Exclusion Criteria:

  1. Actively engaged in moderate to vigorous exercise for more than 40 minutes/ week
  2. Have practiced Tai Chi or other mind-body exercise within the past year
  3. Practiced Tai Chi or other mind-body exercise for 3 or more months in the past 5 years
  4. Physician diagnosis of any condition that might interfere with study participation including the following: unstable cardiac disease, stroke, rheumatoid arthritis, degenerative neuromuscular diseases, Parkinson's disease, terminal disease, or dementing illness

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Active Comparator

    Arm Label

    Light physical exercise

    Tai Chi

    Arm Description

    Normal walking, light intensity resistance exercise and stretching, and health education discussions.

    Joint rotations and balance games, Tai Chi walking drills and the 8 forms.

    Outcomes

    Primary Outcome Measures

    Pain severity
    Pain severity will be assessed using the Brief Pain Inventory.
    Pain interference
    Pain interference will be assessed using the Brief Pain Inventory.
    Fear of falling
    Fear of falling will be assessed using the Tinetti Falls Efficacy Scale.
    Rate of total falls
    Rate of total falls will be assessed using monthly falls calendar postcards.
    Rate of injurious falls
    Rate of injurious falls will be assessed using the Abbreviated Injury Scale.

    Secondary Outcome Measures

    Inflammatory markers
    Plasma levels of C-reactive protein, interleukin 6, tumor necrosis factor alpha and Nuclear Factor kappa B will be measured using enzyme-linked immunosorbent assays.
    Beta endorphin
    Plasma levels of beta endorphin will be measured using an enzyme-linked immunosorbent assay.
    Attention
    Attention will be assessed by using 4 subscales of the Test of Everyday Attention.
    Executive function
    Executive function will be assessed using the Trailmaking test, which requires the connection of sequentially numbered circles (part A), and the connection of circles marked by numbers and letters in alternating sequence (part B).
    Single-task gait
    Gait will be assessed using a sensored gait mat that has embedded pressure sensors distributed throughout the mat. The mat measures location and timing of individual steps, which then can be used to calculate spatio-temporal gait parameters including our outcome measures of stride time, stride length, and swing time.
    Dual-task gait
    Gait will be assessed using a sensored gait mat that has embedded pressure sensors distributed throughout the mat. The mat measures location and timing of individual steps, which then can be used to calculate spatio-temporal gait parameters including our outcome measures of stride time, stride length, and swing time. During the dual task walking, the participants will perform 2 sets of cognitive challenges in random order: serial subtractions 3 and 5 from 100. Dual task performance and number of errors on the serial subtractions will be recorded. Coefficient of variation will be used as a measure of gait variability (SD/mean x 100). The dual task decrement, the difference between single task and dual task gait variability will be measured.

    Full Information

    First Posted
    May 23, 2018
    Last Updated
    November 2, 2020
    Sponsor
    University of Massachusetts, Boston
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03705598
    Brief Title
    Effects of Tai Chi on Multisite Pain and Falls in Older Adults
    Official Title
    Effects of Tai Chi on Multisite Pain and Falls in Older Adults
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2020
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 1, 2021 (Anticipated)
    Primary Completion Date
    August 31, 2024 (Anticipated)
    Study Completion Date
    August 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Massachusetts, Boston

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Accumulating evidence supports that more pain, whether measured by number of pain sites or pain severity, is associated with poorer cognitive function and mobility, and fall risk in older persons. Tai Chi which holistically integrates physical and cognitive functions offers the possibility not only of alleviating pain but also improving attention and mobility in the many older adults who have chronic multisite pain. This proposed full-size randomized controlled Tai Chi trial is a direct extension of our previous work examining chronic pain, attention demands, mobility and falls in the older population, and is built on the investigators' NIA-supported Tai Chi feasibility and acceptability pilot study among older adults with multisite pain and risk for falls. The goal of this single-blinded randomized controlled trial is to examine the effects of a 24-week Tai Chi intervention on chronic pain, cognition, mobility, fear of falling, and rates of total and injurious falls in older adults with multisite pain and at risk for falls. The results of this study will provide a foundation to establish the clinical significance of Tai Chi in the management of chronic multisite pain and to explore the mechanisms through which Tai Chi improves chronic pain symptoms and lowers rates of total and injurious falls in at-risk older adults.
    Detailed Description
    The investigators will measure pain severity, pain interference, pain-related biomarkers, cognition, physical function, single-task and dual-task gait, and fear of falling pre- and post-intervention in 200 older adults (Tai Chi: N=100, and exercise control: N=100). The investigators will also measure rates of total and injurious falls in the 12 months during and following the intervention. The primary aims are: 1. to examine the effects of Tai Chi on pain symptoms in older adults with multisite pain. It is hypothesized that older adults in the Tai Chi intervention will have less pain, measured as pain severity and interference, than those in the light physical exercise control group; 2. to examine the effects of Tai Chi on fear of falling and rates of total and injurious falls in older adults with multisite pain. It is hypothesized that older adults in the Tai Chi intervention will have greater improvements in fear of falling scores and fewer total and injurious falls than those in the light exercise control group in the 48 weeks during and after the Tai Chi intervention. The secondary/exploratory aims are: 3. to examine the effects of Tai Chi on pain-related biomarkers in older adults with multisite pain. It is hypothesized that older adults in the Tai Chi intervention will have lower levels of pain-related biomarkers, than those in the light physical exercise control group; 4. to examine the role of improvement in chronic pain in the reduction of fall rates by Tai Chi in older adults with multisite pain. It is hypothesized that the reductions in fall rates are dependent on the improvement in pain symptoms in older adults with chronic multisite pain; 5. to examine the roles of improvements in cognition and mobility in the reduction of fall rates by Tai Chi in older adults with multisite pain. It is hypothesized that the reductions in chronic pain and in fall rates are mediated by the changes in cognition and mobility in older adults with chronic multisite pain.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Light physical exercise
    Arm Type
    Placebo Comparator
    Arm Description
    Normal walking, light intensity resistance exercise and stretching, and health education discussions.
    Arm Title
    Tai Chi
    Arm Type
    Active Comparator
    Arm Description
    Joint rotations and balance games, Tai Chi walking drills and the 8 forms.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Light physical exercise
    Intervention Description
    One hour each session, two sessions each week, for 24 weeks. Each session includes 10 minutes of warm up, 30 minutes of normal walking, light intensity resistance exercise and stretching, and 20 minutes of health education discussions, supervised by a certified exercise physiologist and a research assistant.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Tai Chi
    Intervention Description
    One hour each session, two sessions each week, for 24 weeks. Each session includes 10 minutes of warm-up that included joint rotations and balance games, 45 minutes of Tai Chi practice that included Tai Chi walking drills and the 8 forms (with 12-15 minutes of breaks), and 5 minutes of cool down and breathing exercises, supervised by an experienced Tai Chi instructor and a research assistant.
    Primary Outcome Measure Information:
    Title
    Pain severity
    Description
    Pain severity will be assessed using the Brief Pain Inventory.
    Time Frame
    24 weeks
    Title
    Pain interference
    Description
    Pain interference will be assessed using the Brief Pain Inventory.
    Time Frame
    24 weeks
    Title
    Fear of falling
    Description
    Fear of falling will be assessed using the Tinetti Falls Efficacy Scale.
    Time Frame
    48 weeks
    Title
    Rate of total falls
    Description
    Rate of total falls will be assessed using monthly falls calendar postcards.
    Time Frame
    48 weeks
    Title
    Rate of injurious falls
    Description
    Rate of injurious falls will be assessed using the Abbreviated Injury Scale.
    Time Frame
    48 weeks
    Secondary Outcome Measure Information:
    Title
    Inflammatory markers
    Description
    Plasma levels of C-reactive protein, interleukin 6, tumor necrosis factor alpha and Nuclear Factor kappa B will be measured using enzyme-linked immunosorbent assays.
    Time Frame
    24 weeks
    Title
    Beta endorphin
    Description
    Plasma levels of beta endorphin will be measured using an enzyme-linked immunosorbent assay.
    Time Frame
    24 weeks
    Title
    Attention
    Description
    Attention will be assessed by using 4 subscales of the Test of Everyday Attention.
    Time Frame
    24 weeks
    Title
    Executive function
    Description
    Executive function will be assessed using the Trailmaking test, which requires the connection of sequentially numbered circles (part A), and the connection of circles marked by numbers and letters in alternating sequence (part B).
    Time Frame
    24 weeks
    Title
    Single-task gait
    Description
    Gait will be assessed using a sensored gait mat that has embedded pressure sensors distributed throughout the mat. The mat measures location and timing of individual steps, which then can be used to calculate spatio-temporal gait parameters including our outcome measures of stride time, stride length, and swing time.
    Time Frame
    24 weeks
    Title
    Dual-task gait
    Description
    Gait will be assessed using a sensored gait mat that has embedded pressure sensors distributed throughout the mat. The mat measures location and timing of individual steps, which then can be used to calculate spatio-temporal gait parameters including our outcome measures of stride time, stride length, and swing time. During the dual task walking, the participants will perform 2 sets of cognitive challenges in random order: serial subtractions 3 and 5 from 100. Dual task performance and number of errors on the serial subtractions will be recorded. Coefficient of variation will be used as a measure of gait variability (SD/mean x 100). The dual task decrement, the difference between single task and dual task gait variability will be measured.
    Time Frame
    24 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Aged 65 years and older have chronic multisite (2 or more sites) musculoskeletal pain (lasting 3 or more months in the previous year and present in the previous month) reports at least 1 fall in the previous year or currently using an assistive device to walk (cane or walker) Able to walk 20-feet without personal assistance has never practiced Tai Chi or other mind-body exercise in the previous 5 years able to communicate in English Exclusion Criteria: Actively engaged in moderate to vigorous exercise for more than 40 minutes/ week Have practiced Tai Chi or other mind-body exercise within the past year Practiced Tai Chi or other mind-body exercise for 3 or more months in the past 5 years Physician diagnosis of any condition that might interfere with study participation including the following: unstable cardiac disease, stroke, rheumatoid arthritis, degenerative neuromuscular diseases, Parkinson's disease, terminal disease, or dementing illness

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Effects of Tai Chi on Multisite Pain and Falls in Older Adults

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