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
About this trial
This is an interventional treatment trial for Chronic Pain
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
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
NCT ID
NCT03705598
First Posted
May 23, 2018
Last Updated
November 2, 2020
Sponsor
University of Massachusetts, Boston
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
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Effects of Tai Chi on Multisite Pain and Falls in Older Adults
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